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Mederma Advanced Scar Allantoin 5 mg/g Gel — NDC 00113-4085-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mederma Advanced Scar Allantoin 5 mg/g Gel — NDC 0113-4085-20 (Billing 00113-4085-20)

by L. Perrigo Company · 1 TUBE in 1 BOX / 20 g in 1 TUBE

This is a package of Mederma Advanced Scar Allantoin 5 mg/g Gel from L. Perrigo Company, marketed since Nov 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00113-4085-20
🏷️ FDA NDC (as labeled) 0113-4085-20 billing pads the labeler segment with a zero
This package
Contains20 g in 1 tube Pack sizes2 compare ↓
Main listing for product 0113-4085 · Also comes in: 50 g 0113-4085-50
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0113-4085-20 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0113 labeler · 4085 product · 20 package
Package marketed since
Nov 27, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0113408520 9
FDA record last changed
Aug 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0113-4085-20
Product NDC 0113-4085
11-digit billing NDC 00113408520
RxCUI 1442087, 1442092
UNII 344S277G0Z
Application # M016
SPL Set ID 9c3d9e08-9428-4b28-82a2-0cb24c3c92a3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-27
Route TOPICAL
Dosage form GEL
Substance ALLANTOIN
Quick answers
  • RxCUI (RxNorm): 1442087
Why two NDCs? The FDA registers this code as 0113-4085-20 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00113-4085-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Mederma Advanced Scar is a topical gel containing allantoin, an ingredient commonly used in over-the-counter scar and skin-care products. This product is marketed under FDA's OTC monograph rules for skin protectants and moisturizers. Allantoin is typically included in skincare formulations to help soften and smooth the skin surface. This gel is applied directly to the skin.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 50 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00113-4085-20 You're viewing this Main listing 1 TUBE in 1 BOX / 20 g in 1 TUBE 2023-11-27 — Active
00113-4085-50 0113-4085-50 1 TUBE in 1 BOX / 50 g in 1 TUBE 2025-04-24 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 box / 20 g in 1 tube.
What NDC number is used to bill for this package of Mederma Advanced Scar Allantoin 5 mg/g Gel?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Baby Soothe and Protect Cream 5 mg/g 00299-4103-05 Galderma 170 g — — FDA listed —
Cetaphil Soothing Gel Cream 5 mg/g 00299-4105-00 Galderma 10 g — — FDA listed —
Manuka Honey Extra Strength 5 mg/g 81995-0050-01 First 1 tube — — FDA listed —
Bed Sore and Wound Healing Cream 5 mg/g 85384-0011-01 TAGRID 30 g — — FDA listed —
DGH Advanced Formula Scar Skin Protectant 5 mg/g 55910-0540-01 Dolgencorp 1 tube — — FDA listed —
Mederma Advanced Scar 5 mg/g 73302-0201-20 PMI 1 tube — — FDA listed —
Mederma Advanced Scar 5 mg/gthis 00113-4085-20 L. 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 1Z74184RGV
    Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 492225Q21H
    A natural ingredient derived from onions, used as a flavoring agent to add taste and aroma to medicines. It helps mask unpleasant flavors in oral formulations.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII R95B8J264J
    Polyethylene glycol 200 is a clear, colorless liquid made from petroleum. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture to keep the product stable.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also states• Water, PEG-4, Alcohol, Xanthan Gum, Allium Cepa (Onion) Bulb Extract, Panthenol, Fragrance, Lecithin, Methylparaben, Sorbic Acid, Sodium Hyaluronate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerL. Perrigo Company
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00113
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio228 products on file

More NDCs from L. Perrigo Company labeler code 00113

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Uses • Temporarily protects and helps relieve chapped or cracked skin

⏱️ Dosage and Administration 5 words ▾

Directions • Apply as needed

⚠️ Warnings 77 words ▾

Warnings • For external use only When using this product • Do not get into eyes Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days Do not use on • Deep puncture wounds • Animal bites • Serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 4 words ▾

Active Ingredients Allantoin 0.5%

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients • Water, PEG-4, Alcohol, Xanthan Gum, Allium Cepa (Onion) Bulb Extract, Panthenol, Fragrance, Lecithin, Methylparaben, Sorbic Acid, Sodium Hyaluronate

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📄 Do Not Use 14 words ▾

Do not use on • Deep puncture wounds • Animal bites • Serious burns

📄 When Using This Product 10 words ▾

When using this product • Do not get into eyes

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Other Information 7 words ▾

Other Information • Store at room temperature

📄 Questions or Comments 12 words ▾

Questions or Comments? • For more information call 1-833-426-6733 or visit www.mederma.com

📄 Package Label / Principal Display Panel 62 words ▾

PRINCIPAL DISPLAY PANEL Clinically shown to visibly reduce the appearance of OLD & NEW SCARS MEDERMA ® Advanced Scar Gel No 1 Doctor & Pharmacist recommended scar brand Skin Protectant 1 X DAILY Triple-Action Formula to helo Lock-in moisture Collagen production Call renewal #1 DOCTOR & PHARMACIST recommended scar brand GEL TUBE NET WT.

1.76 Oz (50g) Mederma Advanced Scar Gel Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mederma Advanced Scar (this brand).

Top reported reactions

Condition Aggravated139
General Physical Health Deterioration137
Hyponatraemia136
Sepsis136
Multiple Organ Dysfunction Syndrome135
Somnolence134
Stress134

Age at onset

Adult6
Elderly45

Reporter sex

0 reports
Male · 91%
Female · 9%

Serious outcomes

Death179
Disabling165
Hospitalization153
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 62 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by L. Perrigo Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (00113-4085-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
L. Perrigo Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00113-4083-20 · L. 00113-4111-06 · L. →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.