P11-4 (Oligopeptide-104)_Dosage, benefits & legal status
Also known as Oligopeptide-104, Curodont, Curodont Repair, Curolox, Ac-QQRFEWEFEQQ-NH2
A dental peptide its own label files as inactive.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is P11-4 (Oligopeptide-104)?
Plain language first. The technical label stays, but it never stands alone.Overview
This is the peptide behind the drill-free cavity treatment your dentist may have mentioned. The idea is that it builds a scaffold inside a lesion that has softened but not yet broken through, so minerals in saliva can rebuild the spot instead of a dentist cutting it out. Two things are worth knowing before reading the marketing. On the US label of the fluoride version, the peptide is not the active ingredient: fluoride is, and the peptide is listed with the inactive ones and no amount at all. The trials behind the published numbers used the older version without fluoride, so the strongest evidence and the biggest-selling product are not the same thing.
P11-4 is an eleven-residue self-assembling peptide, Ac-QQRFEWEFEQQ-NH2, registered by the FDA substance system as oligopeptide-104 under UNII MUM5TLH7X6 and CAS 593266-60-5. Applied to an early enamel lesion it is designed to diffuse into the porous lesion body and assemble into a fibrous three-dimensional matrix. That matrix is intended to act as a scaffold on which mineral from saliva can deposit, a mechanism usually described as guided enamel regeneration rather than a filling. It belongs to the same structural class as RADA16, already covered here. Its route to the US market is unusual: across all fourteen US drug labels that contain it, the stated active ingredient is a fluoride salt and the peptide appears only among the inactive ingredients.
What it's used for
Applied by a dentist to early enamel lesions, including the white spots left after orthodontic brackets, and sold in retail toothpastes built around the same peptide. It is not approved as a drug for treating caries and it has no FDA device clearance.
How does P11-4 (Oligopeptide-104) work?
What it does in the body, and where.Two separate questions get mixed together here: what the peptide is designed to do, and what the product on the shelf is approved to do. The answers are not the same.
- 01It assembles into a scaffoldThe sequence Ac-QQRFEWEFEQQ-NH2 is built to self-assemble. Below a certain pH the eleven-residue peptide switches from free molecules into fibrils, so a liquid applied to a tooth turns into a fibrous matrix once it is inside the acidic, porous body of an early lesion. This is the same trick RADA16 uses to gel on a bleeding surface, applied to enamel instead.
- 02Mineral is supposed to grow on itThe scaffold does not contain mineral and does not deliver any. It is intended to give calcium and phosphate already present in saliva a template to crystallize on, inside a lesion that would otherwise keep losing mineral. That is why the mechanism is described as guided regeneration: the peptide is scaffolding, not cement, and the rebuilding depends on the mouth supplying the material.
- 03On the US label, fluoride does the approved workThe marketed Fluoride Plus product names sodium fluoride as its active ingredient at 0.05%, equivalent to 0.02% fluoride ion. Oligopeptide-104 is one of eight inactive ingredients with no strength stated. Under the OTC monograph system the active ingredient is the one carrying the recognized effect, so the regulatory claim on that package rests on fluoride, a substance with decades of caries evidence of its own.
- 04The evidence and the product have drifted apartThe systematic review that supplies almost every number quoted for this peptide pooled six trials of the fluoride-free formulation. Not one included trial used a Fluoride Plus product. So the best peptide evidence describes a formulation without fluoride, while the formulation most widely sold adds fluoride as its active. A 2025 randomized trial did test a Fluoride Plus regimen on white spot lesions in primary teeth, making it the more relevant study for what is actually on sale.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
What the US label actually says
Supplement or cosmetic- RegulatoryOn CURODONT REPAIR FLUORIDE PLUS the active ingredient is sodium fluoride 0.05%, and oligopeptide-104 is an inactive ingredient with a blank strength column.
- RegulatoryThe product is an OTC Monograph Drug under application M021, not a device. FDA's 510(k) database holds no clearance under either company name, verified against a control search that returned seven results for another oral care company.
- RegulatoryAcross all fourteen US labels containing this peptide, the stated active is always a fluoride salt.
The pooled evidence tested a different formulation
peer-reviewed-human- Human trialSix trials, lesion arrest risk ratio 1.82 (1.32 to 2.50), number needed to treat about 2.8, lesion size down about 32%.
- Human trialCavitation and ICDAS outcomes did not reach significance, at 0.32 (0.10 to 1.06) and 3.68 (0.42 to 32.3).
- No dataNo included trial used any Fluoride Plus formulation, so the pooled effect belongs to the fluoride-free Curodont Repair. A separate 2025 randomized trial did test a Fluoride Plus regimen in primary teeth.
- No dataAll six pooled trials were rated at elevated risk of bias by the reviewers.
Claims that could not be traced to a source
none- No dataA widely repeated success figure above 90% is attributed to a 2024 reference that could not be located, so it is not reproduced here.
- No dataA frequently quoted 15% gain in mineral density traces to a company-funded laboratory study of three samples, described as data on file rather than published.
Identity and the look-alike peptide
none- lab-analysisEleven residues, QQRFEWEFEQQ, acetyl capped and amidated, UNII MUM5TLH7X6, CAS 593266-60-5. The formula and molecular weight fields in the FDA record are blank.
- No dataOligopeptide-10 is a different fifteen-residue skincare peptide, FAKALKALLKALKAL with a C-terminal amide. The 2019 Curodont label's structured data wrongly codes the dental peptide to that UNII.
- RegulatoryThe same peptide also appears in retail OTC toothpastes from a separate labeler, outside any dental office.
Four errors travel with this peptide. The first is calling it the active ingredient. On the US label of the fluoride version it is an inactive ingredient with no strength stated, and sodium fluoride is the active. The second is that the product was FDA cleared in 2019. It is an OTC monograph drug under application M021, and FDA's device database contains no 510(k) under either company name; 2019 is when the first drug listing generation appeared. The third is quoting the meta-analysis numbers for the fluoride product on the shelf, when none of the six pooled trials used a Fluoride Plus formulation. The fourth is a numbers problem: a success rate above 90% is attributed to a reference that could not be found, and a 15% mineral density figure rests on a company-funded laboratory study of three samples described as data on file. Separately, anyone pulling the 2019 label's structured data gets oligopeptide-10, a fifteen-residue skincare peptide, because the record codes the wrong UNII.
The published record
Papers and trials about P11-4 (Oligopeptide-104)
Searched: P11-4, oligopeptide-104, Curodont, self-assembling peptide P11-4.
Left out: oligopeptide-10 (a different fifteen-residue peptide used in skincare, FAKALKALLKALKAL with a C-terminal amide, CAS 466691-40-7, UNII Q46328TRNK. This is observed contamination, not a hypothetical risk: the 2019 Curodont US label codes the dental peptide to that UNII in its structured data, so anyone ingesting label data programmatically picks up the wrong molecule); P11 (the bare stem retrieves unrelated protein fragments and an entire P11 peptide family; it must never be loosened to this); fluoride (the actual active ingredient on every US label containing this peptide, carrying a caries literature of many thousands of records that is not about the peptide); self-assembling peptide (a class term covering RADA16, which has its own slug, plus a large unrelated hydrogel and tissue-engineering literature); remineralization (a very large dental literature spanning fluoride varnish, CPP-ACP and hydroxyapatite, none of which is this compound); Curolox (a technology name used across product generations rather than an identifier for this peptide).
96 papers tagged human · 40 not reviews or lab · 15 clinical trial publications
32 registered trials · 1 with posted results
Furthest stage reached: Approved outside the US, European Union, Switzerland
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about P11-4 (Oligopeptide-104)
Evidence
Supplement
Category
Healing and recovery
Common vial
Varies
Half-life
Not applicable
How much, and do you cycle it?
The range, and whether you take breaks.Set by the finished product; no peptide strength appears on the label, as the product directs. A short course of office applications in the trials, then follow-up Trial dose
The trials applied the product a small number of times and then measured lesions months later, so this is a course rather than an ongoing regimen. The retail toothpastes are a separate, open-ended daily use with no trial behind them.
Not applicableNo figure
No half-life has been published, and a circulating half-life is not the useful measure for a peptide applied to a tooth surface and intended to stay in the lesion it assembles inside.
You can compare this against the whole library to see where it sits.
What does it cost?
Typical dose and cost, in plain numbers.P11-4 (Oligopeptide-104) is not injected in the forms covered here
It is taken on the teeth (applied by a dentist, or in a toothpaste). The label states no strength for the peptide, so there is no dose to calculate here. A dentist applies the product as supplied, and the retail toothpastes are used like any toothpaste.
How do you store it?
Before mixing, and after.Room temperature. Keep the cap on.
P11-4 (Oligopeptide-104) is applied in the mouth, as an in-office gel or in a toothpaste. Keep it at room temperature, away from heat and direct sun, and follow the dates on the pack. There is nothing to mix and no fridge step. An in-office application is handled by the dental practice, not stored at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 55% charged residues, 27% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Expecting the published trial results from a product whose active ingredient is fluoride, since no included trial in the main review used any Fluoride Plus formulation
- A lesion that has already cavitated: the trials enrolled early lesions, not holes
- Any use in place of a dentist's staging of the lesion, since the evidence depends entirely on which lesions were enrolled
Stop and get help
- Swelling of the lips, tongue or throat, or any other sign of an allergic reaction
- Spreading pain or swelling around the treated tooth, since that points to a lesion deeper than a surface one
Common effects
- No common effect has been established for the peptide itself in a published trial.
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is P11-4 (Oligopeptide-104) approved?
And where the numbers on this page come from.Not as a medicine. P11-4 (Oligopeptide-104) is sold without a prescription as a supplement, which is a different thing from being approved as a drug. It is approved in the European Union and Switzerland, but not in the United States.
- Approval statusSupplementSold without a prescription as a dietary supplement. The FDA does not approve supplements before they are sold, and being easy to buy says nothing about whether it works.
- RouteOn the teeth (applied by a dentist, or in a toothpaste)
- Checked1 November 2026
- Approved outside the USEuropean Union, Switzerland.This does not change the United States position above.
- DoseNo dose has been established in people.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesDailyMed label, CURODONT REPAIR FLUORIDE PLUSSystematic review and meta-analysis, Journal of the American Dental AssociationRandomized trial of an intensive regimen in primary teeth, Journal of Evidence-Based Dental PracticeFDA substance registration record for oligopeptide-104FDA substance registration record for oligopeptide-10, the look-alike
What has happened recently
The US regulatory position is the most misreported thing about this peptide. CURODONT REPAIR FLUORIDE PLUS is listed on DailyMed as an OTC Monograph Drug under monograph application M021, labeled by credentis AG, NDC 72247-108. Its active ingredient is printed as SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION). Oligopeptide-104 appears in the inactive ingredient list, alongside anhydrous citric acid, chlorhexidine gluconate, hypromellose, sodium hydroxide, trehalose dihydrate, tromethamine and water, with the strength column left blank. Trade coverage frequently reports that the product was FDA cleared in 2019. FDA's device clearance database returns no 510(k) at all under either company name, while a control search on another oral care company returns seven, so the absence is real rather than a failed query. The 2019 date matches the product's first drug listing generation rather than a device clearance, and an OTC monograph drug is not a cleared device. Three listing generations exist, from 2019, August 2023 and December 2024. One further trap sits in the structured data: the 2019 label's XML codes the peptide to UNII Q46328TRNK. That is OLIGOPEPTIDE-10, a different fifteen-residue peptide used in skincare. Outside the US the product carries CE marking for the European Union and Switzerland, granted in 2012.
You can compare this against the whole library, or read how to check a seller.
What else is like P11-4 (Oligopeptide-104)?
Others in Healing and recovery, side by side.If you're weighing P11-4 (Oligopeptide-104), it's worth reading Palopegteriparatide (Yorvipath), Pentosan Polysulfate (PPS), and PL8177 in the same class.
A dental peptide its own label files as inactive.
- Dose
- Set by the finished product; no peptide strength appears on the label
- How often
- As the product directs
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- Dose
- 18 mcg once daily to start, adjusted within 6 to 30 mcg (label)
- How often
- Once daily
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- Dose
- 300 mg per day (100 mg three times a day)
- How often
- Three times a day (oral)
A melanocortin peptide built around the same core as PT-141, aimed at the gut wall instead of the brain.
- Dose
- Dose not disclosed; taken once daily for 8 weeks in the trial
- How often
- Once daily
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- DailyMed label, CURODONT REPAIR FLUORIDE PLUS(2024)The document that settles what the peptide is on this product. Marketing category OTC Monograph Drug, monograph application M021, labeler credentis AG, NDC 72247-108. Active ingredient printed as SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION). Oligopeptide-104 appears only among the inactive ingredients, with anhydrous citric acid, chlorhexidine gluconate, hypromellose, sodium hydroxide, trehalose dihydrate, tromethamine and water, and its strength column is blank.
- Systematic review and meta-analysis, Journal of the American Dental Association(2023)JADA volume 154, pages 580 to 591.e11. Pooled six trials of self-assembling peptide P11-4. Lesion arrest risk ratio 1.82 with a 95% confidence interval of 1.32 to 2.50, number needed to treat about 2.8, and lesion size reduced by about 32%. Two other outcomes did not reach significance: progression to cavitation at a risk ratio of 0.32 with an interval of 0.10 to 1.06, and ICDAS improvement at 3.68 with an interval of 0.42 to 32.3. All six trials were rated at elevated risk of bias. Critically, no included trial used a Fluoride Plus formulation, so these numbers belong to the fluoride-free product.
- Randomized trial of an intensive regimen in primary teeth, Journal of Evidence-Based Dental Practice(2025)Volume 25, article 102163. A randomized trial of remineralization of white spot lesions in primary teeth. This is the study that tested a Fluoride Plus regimen, making it more directly relevant to the product sold in the US than the pooled trials above, all of which used the fluoride-free version.
- FDA substance registration record for oligopeptide-104(2026)Preferred name OLIGOPEPTIDE-104, CAS 593266-60-5, with the sequence given among the synonyms as Ac-Gln-Gln-Arg-Phe-Glu-Trp-Glu-Phe-Glu-Gln-Gln-NH2, that is eleven residues reading QQRFEWEFEQQ with an acetyl cap and a C-terminal amide. The formula and molecular weight fields are blank in this record, so neither is stated here.
- FDA substance registration record for oligopeptide-10, the look-alike(2026)Preferred name OLIGOPEPTIDE-10, CAS 466691-40-7, sequence Phe-Ala-Lys-Ala-Leu-Lys-Ala-Leu-Leu-Lys-Ala-Leu-Lys-Ala-Leu-NH2, fifteen residues. A different peptide used in skincare, with no relationship to enamel. It matters because the 2019 Curodont label's structured data codes the dental peptide to this UNII, so anyone reading that record programmatically gets the wrong molecule.
Beyond these, 166 records are indexed. Browse the records