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Cetaphil Soothing Gel Cream allantoin 5 mg/g Cream, 453 g — NDC 00299-4105-15 package photo

Cetaphil Soothing Gel Cream allantoin 5 mg/g Cream, 453 g

by Galderma Laboratories, L.P. · 453 g in 1 JAR (0299-4105-15)
NDC 00299-4105-15
🏷️ FDA NDC (as labeled) 0299-4105-15 billing pads the labeler segment with a zero
This package
Contains453 g Pack sizes4 compare ↓
Also comes in: 10 g 00299-4105-00 85 g 00299-4105-05 226 g 00299-4105-10
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 0299-4105-15
Product NDC 0299-4105
11-digit billing NDC 00299410515
RxCUI 241509
UNII 344S277G0Z
Application # M016
SPL Set ID bab404f0-2f7a-4bac-b053-cbdc81c029b5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-02-17
Route TOPICAL
Dosage form CREAM
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 0299-4105-15 — 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 → 00299-4105-15. 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.

🏭 Manufacturer & labeler

LabelerGalderma Laboratories, L.P.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00299
First marketedFeb 2020
Product typeHuman Otc Drug
Portfolio50 products on file
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.

🩺 Clinical

🧪 What is this product?

Cetaphil Soothing Gel Cream is a topical cream containing allantoin, an ingredient commonly used in over-the-counter skin care products. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for its ingredient category rather than undergoing individual application review. Allantoin is typically used to help soothe and moisturize the skin. The cream is applied directly to the skin surface.

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.

🧪 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII E00JL9G9K0
    A plant-derived cleaning agent made from coconut oil and natural sugars. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients together in the medicine.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • 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 J288D7O0JS
    A chemical compound derived from pantothenic acid (vitamin B5). It acts as a stabilizer and preservative in medications to help maintain product quality and extend shelf life.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 5XB3A63Y52
    A synthetic rubber polymer used as a glidant and lubricant in tablet and capsule formulations. It reduces friction between particles and equipment surfaces, helping medicines flow smoothly during manufacturing and preventing sticking.
  • UNII O88E196QRF
    Sheanut oil is a natural fat extracted from shea nuts grown in Africa. It's used in medicines as an emollient, lubricant, and binding agent to improve texture, help ingredients mix smoothly, and keep the product stable.
  • UNII 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling 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.

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

The official label also statesALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER

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.

💲 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: 10 g 85 g 226 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.

🔁 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/gthis 00299-4105-15 Galderma 453 g — — FDA listed —
Teevodar .5 g/100g 69435-1301-01 PEER 1 tube — — FDA listed —
DeFlame 5 mg/mL 78863-1270-01 Noon 1 tube — — FDA listed —
Drs. pharmacy Scar Cream .5 g/100g 80489-0333-01 OL 1 tube — — FDA listed —
First honey Burn Salve 5 mg/mL 81995-0056-01 First 1 tube — — FDA listed —
Bed Sore and Wound Healing Cream 5 mg/g 85384-0011-01 TAGRID 30 g — — FDA listed —
Advanced Formula Scar Defense Cream .5 g/100g 87512-0002-01 Yantai 20 g — — FDA listed —
Advanced Silicone Scar .5 g/100g 87512-0006-01 Yantai 20 g — — FDA listed —
Manuka Honey Extra Strength 5 mg/g 81995-0050-01 First 1 tube — — 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/g 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.

🔬 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 Cetaphil Soothing Gel Cream (this brand).

Top reported reactions

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

Age at onset

Adult5
Elderly45

Reporter sex

212 reports
Male · 92%
Female · 8%

Serious outcomes

Death179
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 61 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00299-4105-00 10 g in 1 TUBE (0299-4105-00) 2020-02-17 Active
00299-4105-05 85 g in 1 TUBE (0299-4105-05) 2020-02-17 Active
00299-4105-10 226 g in 1 TUBE (0299-4105-10) 2020-02-17 Active
00299-4105-15 You're viewing this 453 g in 1 JAR (0299-4105-15) 2020-02-17 Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 00299-4105-15?
NDC 00299-4105-15 contains 453 g — 453 g in 1 jar.
What is the difference between NDC 00299-4105-15 and NDC 00299-4105-00?
Both are Cetaphil Soothing Gel Cream allantoin 5 mg/g Cream — the drug itself is identical. NDC 00299-4105-15 is the 453 g package, while NDC 00299-4105-00 is the 10 g package.
What NDC number is used to bill for this package of Cetaphil Soothing Gel Cream allantoin 5 mg/g Cream?
Bill NDC 00299-4105-15 — the 11-digit billing format is 00299410515. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 0299-4105-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00299-4105-15, written without dashes as 00299410515. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00299-4105-15, the first segment (00299) is the labeler code FDA assigned to Galderma Laboratories, L.P.; the middle segment (4105) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Galderma Laboratories, L.P.. 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 3 other package presentations of this same product, including 10 g (00299-4105-00), 85 g (00299-4105-05), 226 g (00299-4105-10). 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?
Galderma Laboratories, L.P. 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.

📄 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
🎯 Indications and Usage 20 words ▾

Uses Temporarily protects minor: ●cuts ●scrapes ●burns ■helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin

⏱️ Dosage and Administration 4 words ▾

Directions ■Apply as needed

⚠️ Warnings 73 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 or 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.

🧪 Active Ingredient 5 words ▾

Active ingredients......Purpose Allantoin 0.5%......Skin Protectant

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients ALOE BARBADENSIS LEAF JUICE POWDER, BUTYROSPERMUM PARKII (SHEA) OIL, CAPRYLYL GLYCOL, CAPRYLYL/CAPRYL GLUCOSIDE, CITRIC ACID, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYLPROPANEDIOL, PANTHENOL, PANTOLACTONE, PHENOXYETHANOL, POLYISOBUTENE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, TOCOPHEROL, WATER

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00299-4103-05 · Galderma 00299-4108-00 · Galderma →
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.