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Cetaphil Eczema Soothing Moisturizer colloidal oatmeal 1 g/100mL Lotion, 473 mL — NDC 00299-4128-10 package photo

Cetaphil Eczema Soothing Moisturizer colloidal oatmeal 1 g/100mL Lotion, 473 mL

by Galderma Laboratories, L.P. · 473 mL in 1 BOTTLE, PUMP (0299-4128-10)
NDC 00299-4128-10
🏷️ FDA NDC (as labeled) 0299-4128-10 billing pads the labeler segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 0299-4128-10
Product NDC 0299-4128
11-digit billing NDC 00299412810
RxCUI 240464
UNII 8PI54V663Y
Application # M016
SPL Set ID 0d01c3fb-d420-484d-aae1-33234c9e383e
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-01
Route TOPICAL
Dosage form LOTION
Substance OATMEAL
GCN Seq No 015974
GCN 21491
HICL code 002224
Ingredient (HICL) Colloidal Oatmeal
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L2
Therapeutic class — intermediate (HIC2) Emollients
HIC3 code L2A
Therapeutic class — specific (HIC3) Emollients
AHFS code 84:24.04.00
AHFS class Basic Lotions And Liniments
FDB label name CETAPHIL ECZEMA RESTORADERM
FDB brand name Cetaphil Eczema Restoraderm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0299-4128-10 — 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 → 00299-4128-10. 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.

🏷️ RxNorm drug class

This medicine belongs to the Non-Standardized Food Allergenic Extract class.

Pharmacologic class Non-Standardized Food Allergenic Extract, Non-Standardized Plant Allergenic Extract
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGalderma Laboratories, L.P.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00299
First marketedMay 2022
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

Label name CETAPHIL ECZEMA RESTORADERM Ingredient Colloidal Oatmeal
🧪 What is this product?

Cetaphil Eczema Soothing Moisturizer is a topical lotion containing colloidal oatmeal, an over-the-counter monograph product. Colloidal oatmeal is typically used in skincare products for its moisturizing and soothing properties, and is commonly applied to dry or irritated skin. This lotion is formulated for topical application and is intended to be used as a skin care product rather than a treatment requiring a prescription.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid 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 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII OSA9UP217S
    Dimethiconol is a silicone-based lubricant and anti-foaming agent. It reduces friction between tablet components and prevents foam formation during manufacturing and storage.
  • UNII QI9A6U005W
    A synthetic cleansing agent derived from coconut oil and polyethylene glycol. In medicines, it acts as a surfactant to help mix oil and water-based ingredients and improve how the product spreads or dissolves.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII WH8T92A065
    A fatty acid derivative made by combining stearic acid with glycerin and citric acid. It acts as an emulsifier to help mix oil and water-based ingredients, and also serves as a thickener in the medicine formulation.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 90PS6JV9GZ
    A plant-derived ingredient from the Ophiopogon japonicus root, used in traditional medicine formulations. It may serve as a natural filler or consistency agent in herbal preparations.
  • 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 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • 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 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 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.

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

The official label also statesWATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, SORBITOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, ARGININE, NIACINAMIDE, GLYCERYL STEARATE CITRATE, SODIUM POLYACRYLATE, DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE, CAPRYLYL GLYCOL, CETEARETH-20, SODIUM PCA, PANTHENOL, CITRIC ACID, ALLANTOIN, DIMETHICONOL, OPHIOPOGON JAPONICUS ROOT EXTRACT, DISODIUM EDTA, MALTODEXTRIN, SODIUM HYALURONATE, CERAMIDE NP, PANTOLACTONE

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 DailyMedingredient 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: 29 ml 296 ml
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 Eczema Soothing Moisturizer 1 g/100mLthis 00299-4128-10 Galderma 473 ml FDA listed
Cetaphil Baby Eczema Soothing 1 g/100mL 00299-4140-05 Galderma 147 ml FDA listed
Walgreens Eczema 10 mg/g 00363-0258-86 WALGREEN 207 g FDA listed
Derma E Eczema Relief 10 mg/mL 54108-8712-01 derma 175 ml FDA listed
EczemaHoneyBodyLotion 1 g/100g 62742-4234-01 Allure 226.79 g FDA listed
Mustela Stelatopia Intense Eczema Relief Skin Protectant 10 mg/mL 64768-7024-01 Expanscience 30 ml FDA listed
Dove DermaSeries Eczema Relief Soothing Body 1 g/100mL 64942-1503-01 Conopco, 50 ml FDA listed
Dove 1 g/100mL 64942-1870-01 Conopco, 50 ml FDA listed
Colloidal oatmeal 10 mg/g 69842-0214-28 CVS 141 g FDA listed
Colloidal Oatmeal 10 mg/g 79903-0438-05 Walmart 141 g FDA listed
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION 1 g/100mL 84148-0028-01 Guangzhou 300 ml FDA listed
Pipette Eczema 10 mg/mL 84723-0004-02 Pipette 1 bottle FDA listed
Skin Mercy Intense Recovery Cream 1 g/100mL 80921-0001-50 Cultskin 1 tube FDA listed
Barrier Build Skin Protectant Cream 1 g/100mL 81110-0800-02 ILIA, 1 jar FDA listed
Evereden Healing Eczema Treatment 1 g/100mL 72113-0106-03 Eden 1 tube FDA listed
Skin Mercy Recovery Cream 1 g/100mL 80921-0002-50 Cultskin 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00299-4128-00 296 mL in 1 BOTTLE, PUMP (0299-4128-00) 2022-05-01 Active
00299-4128-05 29 mL in 1 BOTTLE (0299-4128-05) 2022-05-01 Active
00299-4128-10 You're viewing this 473 mL in 1 BOTTLE, PUMP (0299-4128-10) 2024-05-01 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 00299-4128-10?
NDC 00299-4128-10 contains 473 mL — 473 ml in 1 bottle, pump.
What is the difference between NDC 00299-4128-10 and NDC 00299-4128-05?
Both are Cetaphil Eczema Soothing Moisturizer colloidal oatmeal 1 g/100mL Lotion — the drug itself is identical. NDC 00299-4128-10 is the 473 mL package, while NDC 00299-4128-05 is the 29 ml package.
What NDC number is used to bill for this package of Cetaphil Eczema Soothing Moisturizer colloidal oatmeal 1 g/100mL Lotion?
Bill NDC 00299-4128-10 — the 11-digit billing format is 00299412810. 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 0299-4128-10, 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: 00299-4128-10, written without dashes as 00299412810. 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 00299-4128-10, the first segment (00299) is the labeler code FDA assigned to Galderma Laboratories, L.P.; the middle segment (4128) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 2 other package presentations of this same product, including 29 ml (00299-4128-05), 296 ml (00299-4128-00). 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 15 words

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: ●Eczema ●Rashes

⏱️ Dosage and Administration 4 words

Directions Apply as needed

⚠️ Warnings 61 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words

Active ingredients......Purpose Colloidal Oatmeal 1%......Skin Protectant

🧪 Inactive Ingredients 63 words

Inactive Ingredients WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, SORBITOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, ARGININE, NIACINAMIDE, GLYCERYL STEARATE CITRATE, SODIUM POLYACRYLATE, DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE, CAPRYLYL GLYCOL, CETEARETH-20, SODIUM PCA, PANTHENOL, CITRIC ACID, ALLANTOIN, DIMETHICONOL, OPHIOPOGON JAPONICUS ROOT EXTRACT, DISODIUM EDTA, MALTODEXTRIN, SODIUM HYALURONATE, CERAMIDE NP, PANTOLACTONE

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