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La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief Oatmeal 10 mg/mL Cream — NDC 49967-0621-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief Oatmeal 10 mg/mL Cream — NDC 49967-621-03 (Billing 49967-0621-03)

by L'Oreal USA Products Inc · 1 TUBE in 1 CARTON / 3 mL in 1 TUBE

This is a package of La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief Oatmeal 10 mg/mL Cream from L'Oreal USA Products Inc, marketed since Nov 2017 and currently FDA-listed.

NDC 49967-0621-03
🏷️ FDA NDC (as labeled) 49967-621-03 billing pads the product segment with a zero
This package
Contains3 mL in 1 tube Pack sizes3 compare ↓
Product page 49967-0621-01 Also comes in: 5 mL 49967-621-01 200 ml 49967-621-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 49967-621-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49967 labeler · 621 product · 03 package
Package marketed since
Nov 21, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
3337875588621
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49967-621-03
Product NDC 49967-621
11-digit billing NDC 49967062103
RxCUI 240651
UNII 8PI54V663Y
UPC 3337875588621
Application # M016
SPL Set ID f7b71606-0044-4729-82e8-4514331806a0
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 2017-11-21
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Quick answers
  • RxCUI (RxNorm): 240651
Why two NDCs? The FDA registers this code as 49967-621-03 — a 5-3-2 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 product segment → 49967-0621-03. 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.

Clinical

🧪 What is this product?

This is a topical cream containing oatmeal, marketed as an over-the-counter monograph product for skin care. Oatmeal in topical formulations is commonly used to soothe and relieve irritated or inflamed skin. This product is designed for application to the skin to help address discomfort associated with eczema and similar skin conditions. As an OTC monograph drug, it is regulated under FDA guidelines for its product category.

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: 5 mL 200 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49967-0621-01 49967-621-01 Main listing 1 TUBE in 1 CARTON / 5 mL in 1 TUBE 2017-11-21 — Discontinued by firm
49967-0621-02 49967-621-02 200 mL in 1 TUBE 2017-11-21 — Active
49967-0621-03 You're viewing this 1 TUBE in 1 CARTON / 3 mL in 1 TUBE 2017-11-21 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 3 ml in 1 tube.
What NDC number is used to bill for this package of La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief Oatmeal 10 mg/mL Cream?
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
Baby Eczema Therapy 10 mg/g 00363-0986-28 Walgreen 141 g — — Discontinued —
Walgreens Eczema Relief Body Skin Protectant 10 mg/g 00363-8395-01 Walgreen 226 g — — FDA listed —
Eucerin Eczema Relief Body 1 g/100g 10356-0365-02 Beiersdorf 7 g — — FDA listed —
Eucerin Eczema Relief Flare Up Treatment 1 g/100g 10356-0371-07 Beiersdorf 57 g — — FDA listed —
Eczema Soothing Moisturizing Cream 10 mg/g 11344-0965-98 Nice-Pak 207 g — — FDA listed —
SOOTHE Moisturizing Rescue Cream .01 g/mL 14222-2430-01 Rodan 1 tube — — FDA listed —
Colloidal oatmeal 10 mg/g 37808-0128-28 H 141 g — — FDA listed —
CeraVe Developed With Dermatologist Baby Eczema Relief Cream 10 mg/mL 49967-0536-01 L'Oreal 148 ml — — FDA listed —
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery 10 mg/mL 49967-0571-01 LOreal 1 tube — — FDA listed —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief 10 mg/mLthis 49967-0621-03 L'Oreal 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Eczema Relief Creamy 10 mg/mL 49967-0951-01 L'Oreal 236 ml — — FDA listed —
Derma-e Eczema Relief .01 g/g 51326-0870-04 Topiderm, 1 jar — — FDA listed —
Eczema 10 mg/mL 52915-0120-02 ORGANIC 57 ml — — FDA listed —
Renew Intensive Skin Therapy Targeted Eczema Treatment .5 g/50mL 54473-0410-01 Melaleuca 50 ml — — FDA listed —
Eczema Hand Relief 1 g/100g 61328-0010-00 Skinfix, 90 g — — FDA listed —
Skinfix Hand Repair 1 g/100mL 61328-0106-11 Skinfix, 30 ml — — FDA listed —
Skin Soothing Cream - Nut Free 1 mg/g 62742-4194-01 Allure 113.5 g — — FDA listed —
Baby Eczema Therapy 10 mg/g 64024-0601-34 Aldi, 227 g — — FDA listed —
Avene XERACALM Eczema Calming Relief Balm 1 g/100g 64760-0777-01 Pierre 100 g — — FDA listed —
Honest Eczema Cream 1 g/100g 69366-0504-19 The 200 g — — FDA listed —
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free 1 g/100g 69423-0743-48 The 1 jar — — FDA listed —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief 10 mg/mL 69625-0620-02 COSMETIQUE 200 ml — — FDA listed —
CVS Eczema Relief Skin Protectant 10 mg/g 69842-0388-01 CVS 226 g — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/g 69968-0404-01 Kenvue 14 g — — FDA listed —
Aveeno Eczema Therapy Itch Relief Balm 10 mg/g 69968-0419-01 Kenvue 312 g — — FDA listed —
Aveeno Eczema Therapy daily moisturizing 10 mg/g 69968-0421-01 Kenvue 14 g — — FDA listed —
Aveeno Baby Eczema Therapy Nighttime Balm 10 mg/g 69968-0540-01 Kenvue 312 g — — FDA listed —
Aveeno Calm Plus Restore Skin Therapy Balm 10 mg/g 69968-0755-02 Kenvue 1 tube — — FDA listed —
Aveeno Eczema Therapy Nighttime Itch Relief Balm 10 mg/g 69968-0772-01 Kenvue 312 g — — FDA listed —
Aveeno Eczema Therapy Daily Moisturizing 10 mg/mL 69968-0774-02 Kenvue 354 ml — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/g 69968-0901-02 Kenvue 341 g — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray 69968-0921-09 Kenvue 1 kit — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/mL 69968-0923-02 Kenvue 354 ml — — FDA listed —
Eczema Relief Cream 1 g/100g 71521-0025-15 Lavior 15 g — — FDA listed —
DERMA SANTE Anti Eczema Cream 10 mg/mL 71970-0324-00 Hope 1 tube — — FDA listed —
Evereden Healing Eczema Treatment 1 g/100mL 72113-0106-03 Eden 1 tube — — FDA listed —
Mountain Ice Eczema 10 mg/g 72793-0400-01 Mountainside 118 g — — FDA listed —
LMNOOP Eczema Relief Cream 1 g/100g 73076-0128-01 Shenzhen 50 g — — FDA listed —
LMNOOP Baby Eczema Relief Cream 1 g/100g 73076-0141-02 Shenzhen 100 g — — FDA listed —
LMNOOP Urticaria Cream 1 g/100g 73076-0142-02 Shenzhen 100 g — — FDA listed —
iShancare Anti-itch Cream 1 g/100g 73076-0145-01 Shenzhen 10 g — — FDA listed —
LMNOOP Antifungal Cream 1 g/100g 73076-0147-01 Shenzhen 50 g — — FDA listed —
LMNOOP Itch Relief Cream 1 g/100g 73076-0148-01 Shenzhen 50 g — — FDA listed —
iShancare Baby Eczema Cream 1 g/100g 73076-0152-02 Shenzhen 100 g — — FDA listed —
iShancare Seborrheic Dermatitis Cream 1 g/100g 73076-0153-01 Shenzhen 50 g — — FDA listed —
LMNOOP Tinea Treatment 1 g/100g 73076-0200-01 Shenzhen 50 g — — FDA listed —
LMNOOP Athletes Foot Cream 1 g/100g 73076-0201-01 Shenzhen 50 g — — FDA listed —
LMNOOP Seborrheic Dermatitis Treatment 1 g/100g 73076-0203-01 Shenzhen 50 g — — FDA listed —
LMNOOP Feminine Cream 1 g/100g 73076-0205-01 Shenzhen 50 g — — FDA listed —
LMNOOP Vaginal Antifungal Cream 1 g/100g 73076-0208-01 Shenzhen 1 applicator — — FDA listed —
LMNOOP Eczema Relief Cream 1 g/100g 73076-0209-03 Shenzhen 100 g — — FDA listed —
Yimimde Tinea Corporis Cream 1 g/100g 73076-0307-03 Shenzhen 100 g — — FDA listed —
Yimimde Masculine Care Cream 1 g/100g 73076-0308-02 Shenzhen 56 g — — FDA listed —
HOMWIS Urticaria Relief Cream 1 g/100g 73076-0506-02 Shenzhen 50 g — — FDA listed —
Colloidal oatmeal 10 mg/g 79481-6601-01 Meijer, 141 g — — FDA listed —
Colloidal oatmeal 10 mg/g 79481-9965-01 Meijer, 207 g — — FDA listed —
Skin Mercy Intense Recovery Cream 1 g/100mL 80921-0001-50 Cultskin 1 tube — — FDA listed —
Skin Mercy Recovery Cream 1 g/100mL 80921-0002-50 Cultskin 1 tube — — FDA listed —
Barrier Build Skin Protectant Cream 1 g/100mL 81110-0800-02 ILIA, 1 jar — — FDA listed —
M3 NATURALS Eczema Cream 10 mg/mL 81985-0186-01 M3 118 ml — — FDA listed —
CeraVe Developed with Dermatologists Eczema Relief Moisturizing 10 mg/mL 82046-0040-01 L'Oreal 236 ml — — FDA listed —
THERAPLEX Eczema Therapy 10 mg/g 82280-0425-00 THERAPLEX, 170.1 g — — FDA listed —
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal 10 mg/g 82280-0618-00 THERAPLEX, 85.05 g — — FDA listed —
THERAPLEX Eczema Therapy 10 mg/g 82280-0816-00 THERAPLEX, 170.1 g — — FDA listed —
Prequel Barrier Cream 1 g/100g 82800-0009-01 The 296 g — — Discontinued —
DERMOIA Manuka Honey Eczema Cream 10 mg/mL 83524-0407-00 TREASUREWISE 120 ml — — FDA listed —
Puriya Eczema Cream 1 g/100g 84711-0002-04 IPC 113 g — — FDA listed —
Serawise Eczema Rescue 10 mg/mL 85050-0575-00 DrAnaMaria.com 1 jar — — FDA listed —
Soteri Skin Long-Term Eczema Relief Cream 1 g/100mL 85265-0103-01 Soteri 1 bottle — — FDA listed —
Eczema Cream 1 g/100mL 85303-0001-01 Kyte 100 ml — — FDA listed —
Tagrid Eczema Cream Colloidal Oatmeal 1% 1 g/100g 85384-0024-01 TAGRID 56.7 g — — FDA listed —
RoyceDerm Eczema Relief Cream 1.13 g/113g 85424-0010-01 RoyceDerm 113 g — — FDA listed —
Eczema Therapy .96 g/96g 85951-0010-01 SilverCeuticals 1 g — — FDA listed —
Radlive Active Defense Nano-Silver Cream .96 g/96g 85951-0200-34 SilverCeuticals 1 g — — FDA listed —
Neurexa 10 mg/mL 87110-0004-01 METHODIQ 1 tube — — FDA listed —
Baby Eczema Moisturizing Cream 1 g/100g 87781-0003-01 Foshan 80 g — — FDA listed —
Derma E Eczema Relief 10 mg/mL 54108-8712-01 derma 175 ml — — FDA listed —
BIA Eczema Relief 10 mg/mL 83196-0582-10 Codex 1 tube — — FDA listed —
Dermoia Eczema Relief Colloidal Oatmeal 10 mg/mL 83524-0944-00 Treasurewise 355 ml — — FDA listed —
Eczema 10 mg/mL 52915-0010-05 ORGANIC 14 ml — — FDA listed —
Serawise Eczema Relief 10 mg/mL 85050-0012-00 DrAnaMaria. 1 jar — — 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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • UNII 8TY5YO42NJ
    Capryloyl glycine is a mild, skin-conditioning ingredient made from a natural fatty acid and the amino acid glycine. In medicines, it acts as a surfactant and preservative booster, helping the product spread evenly and resist contamination.
  • 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 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 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 PHA4727WTP
    Mannose is a simple sugar derived from natural sources. In medicines, it acts as a filler, binder, and sweetener to help form tablets and improve taste.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 0345752X7U
    A synthetic compound made from polyethylene glycol, glucose, and stearic acid. It acts as an emulsifier to help blend oil and water-based ingredients, and improves how the medicine dissolves and is absorbed in the body.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 6LUM696811
    A waxy substance derived from sorbitol and stearic acid. It acts as an emulsifier and stabilizer to help mix oil and water components evenly throughout the medicine and prevent separation.
  • 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.
  • 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.

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

The official label also stateswater, shea butter, glycerin, dimethicone, mineral oil, niacinamide, cetearyl alcohol, rapeseed seed oil, ammonium polyacryloyldimethyl taurate, PEG-100 stearate, glyceryl stearate, tocopherol, sodium benzoate, PEG-20 methyl glucose sesquistearate, dimethiconol, mannose, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, capryloyl glycine, microcrystalline wax, sorbitan tristearate, paraffin, discodium EDTA, vitreoscilla ferment, citric acid

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'Oreal USA Products Inc
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code49967
First marketedNov 2017
Product typeHuman Otc Drug
Portfolio199 products on file

More NDCs from L'Oreal USA Products Inc labeler code 49967

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active ingredient Colloidal oatmeal 1%

🧪 Inactive Ingredients 49 words ▾

Inactive ingredients water, shea butter, glycerin, dimethicone, mineral oil, niacinamide, cetearyl alcohol, rapeseed seed oil, ammonium polyacryloyldimethyl taurate, PEG-100 stearate, glyceryl stearate, tocopherol, sodium benzoate, PEG-20 methyl glucose sesquistearate, dimethiconol, mannose, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, capryloyl glycine, microcrystalline wax, sorbitan tristearate, paraffin, discodium EDTA, vitreoscilla ferment, citric acid

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 25 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 19 words ▾

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

📄 Questions or Comments 15 words ▾

Questions or comments? 1-888-LRP LABO 1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

📄 Package Label / Principal Display Panel 4 words ▾

image of a label

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

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'Oreal USA Products Inc. 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 1 tube (49967-0621-01), 200 ml (49967-0621-02). 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'Oreal USA Products Inc 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.
← 49967-0618-01 · L'Oreal 49967-0630-01 · L'Oreal →
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.