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CeraVe Acne Foaming CreamWash benzoyl peroxide 100 mg/mL Cream — NDC 49967-604-01 (Billing 49967-0604-01)

by L'Oreal USA Products Inc · 1 TUBE in 1 CARTON / 150 mL in 1 TUBE

This is a package of CeraVe Acne Foaming CreamWash benzoyl peroxide 100 mg/mL Cream from L'Oreal USA Products Inc, no longer marketed (first marketed Dec 2023), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 49967-0604-01
🏷️ FDA NDC (as labeled) 49967-604-01 billing pads the product segment with a zero
This package
Contains150 mL in 1 tube Pack sizes2 compare ↓
Main listing for product 49967-604 · Also comes in: 10 mL 49967-604-02
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 49967-604-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49967 labeler · 604 product · 01 package
Package marketed since
Dec 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
3606000604520
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jan 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49967-604-01
Product NDC 49967-604
11-digit billing NDC 49967060401
RxCUI 142034
UNII W9WZN9A0GM
UPC 3606000604520
Application # M006
SPL Set ID 06950d35-daa8-4ea3-bd33-6e9c162e2a63
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jan 2024)
Marketing start 2023-12-01
Route TOPICAL
Dosage form CREAM
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 142034
Why two NDCs? The FDA registers this code as 49967-604-01 — 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 → 49967-0604-01. 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 Peroxides class.

Drug family (ATC) Peroxides
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

📗 Our plain-language guide HelloPharmacist
  • Most products are for acne. They dry up pimples and help prevent new ones. Epsolay is a prescription cream for rosacea bumps in adults. The Folliculitis Treatment Cream products ar...
  • For many acne products, start with once a day. You can move up to two or three times daily if your skin tolerates it. If you get dryness or peeling, cut back to once daily or every...
  • Redness, dryness, peeling, itching, and stinging or burning are the usual ones. Using less often can help. Using another acne product at the same time makes irritation more likely.
  • Stop if irritation gets severe. Stop right away and get help if you have hives, swelling or trouble breathing. Those can be signs of a serious allergic reaction.
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzoyl Peroxide (3 interactions) — ranked by severity →
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: 10 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
49967-0604-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 150 mL in 1 TUBE 2023-12-01 — Discontinued by firm
49967-0604-02 49967-604-02 1 TUBE in 1 CARTON / 10 mL in 1 TUBE 2023-12-01 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 150 ml in 1 tube.
What NDC number is used to bill for this package of CeraVe Acne Foaming CreamWash benzoyl peroxide 100 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
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 Rugby 237 g $0.047 — Discontinued —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 Rugby 237 g $0.047 — Availability likely —
Benzoyl Peroxide 100 mg/mL 35573-0454-08 Burel 237 ml $0.047 — Availability likely —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/mL 00536-1261-63 Rugby 148 ml $0.047 — Availability likely —
benzoyl peroxide 10 g/100g 45802-0318-01 Padagis 142 g $0.048 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1058-75 Rugby 1 tube $0.074 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 00536-1056-25 Rugby 1 tube $0.231 — Discontinued —
Differin Max Strength Acne Foaming BPO Cleanser 10 g/100mL 00299-4137-00 Galderma 1 tube — — FDA listed —
PanOxyl 100 mg/g 00316-0228-01 Crown 1 tube — — Discontinued —
Walgreens Acne Foaming Wash Acne Medication 100 mg/g 00363-1522-01 Walgreen 156 g — — FDA listed —
Walgreens Acne Control Cleanser Acne Medication 100 mg/g 00363-3602-01 Walgreen 142 g — — FDA listed —
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/mL 10742-1202-01 The 148 ml — — FDA listed —
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/g 10742-1206-01 The 3 g — — FDA listed —
OXY 10 Acne Cleanser 100 mg/mL 10742-1397-01 The 148 ml — — FDA listed —
BP Wash 100 mg/g 24470-0901-05 CINTEX 142 g — — Discontinued —
Acne Cleanser 100 mg/g 41250-0264-56 Meijer, 141 g — — FDA listed —
Acne Cleanser 100 mg/g 49035-0264-56 Walmart, 141 g — — FDA listed —
CeraVe Acne Foaming CreamWash 100 mg/mLthis 49967-0604-01 L'Oreal 1 tube — — Discontinued —
Replenix Acne Solutions Wash 100 mg/mL 51326-0112-01 Topiderm, 200 ml — — FDA listed —
Replenix Acne 10% Wash Paraben Free With Aloe 100 mg/mL 51326-0113-01 Topiderm, 200 ml — — FDA listed —
Dr. Zenovia Acne Cleanser 100 mg/mL 51326-0803-01 Topiderm, 1 bottle — — FDA listed —
humane acne wash 100 mg/mL 69919-0021-01 Banner 1 tube — — FDA listed —
HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide 100 mg/mL 69919-0527-08 Banner 1 bottle — — FDA listed —
MEDPURA Benzoyl Peroxide 100 mg/mL 71399-9236-05 Akron 148 ml — — FDA listed —
benzoyl peroxide 10 g/100g 72162-2337-02 Bryant 142 g — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 72288-0264-56 Amazon.com 141 g — — FDA listed —
Humane Acne Wash 100 mg/mL 73010-0900-00 Apprendista, 237 ml — — FDA listed —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 75376-0474-42 Guangzhou 237 g — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 76162-0264-28 Topco 141 g — — FDA listed —
Meijer Maximum Strength Foaming Acne Face Wash Acne Medication 100 mg/g 79481-0022-01 Meijer 1 tube — — FDA listed —
Equate Acne Wash Acne medication 100 mg/g 79903-0061-01 Wal-Mart 1 tube — — FDA listed —
Benzoyl Peroxide Deep Cleansing Foaming Wash .1 g/g 80861-0112-01 AcneFree, 1 g — — FDA listed —
BENZOYL PEROXIDE 10% Topical wash 100 mg/mL 82461-0313-05 Medcore 148 ml — — FDA listed —
Acne Med 10% 100 mg/mL 70707-0212-15 Face 1 bottle — — FDA listed —
Terminator 10 100 mg/mL 80861-0002-01 AcneFree, 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 50090-1792-00 A-S 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/mL 68071-4393-01 NuCare 42.5 ml — — FDA listed —
ZO Skin Health Acne Control Benzoyl Peroxide 100 mg/mL 42851-0087-60 ZO 1 tube — — FDA listed —
10 Acne Med 100 mg/mL 70707-0151-15 Face 1 tube — — FDA listed —
Face Reality 10% Advanced Acne Med 100 mg/mL 70707-0158-01 Face 1 tube — — FDA listed —
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL 71399-9474-05 Akron 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
Dec 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.

🧪 Avoiding an ingredient? See Benzoyl Peroxide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 5THT33P7X7
    A waxy, lipid-like substance derived from animal or plant sources. It helps soften and moisturize the skin by acting as an emollient and skin-conditioning agent in topical medicines and creams.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • 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 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII 62V75NI93W
    A surfactant derived from coconut oil that helps cleanse and remove oils from skin or hair. In medicines and personal care products, it acts as a cleanser and foaming agent.
  • UNII F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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 0WT12SX38S
    Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
  • 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 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 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and stability.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 7243K85WFO
    Sodium lauroyl lactylate is a mild surfactant derived from natural fats and lactic acid. It acts as an emulsifier and solubilizer to help blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • 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.

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

The official label also stateswater, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer,, niacinamide, glycolic acid, trideceth-6, triethyl citrate, sodium citrate, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, cholesterol, propanediol, tetrasodium EDTA, caprylyl glycol, diethylhexyl sodium sulfosuccinate, phytosphingosine, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, benzoic acid, PEG-30 dipolyhydroxystearate

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 applicationM006 (OTC MONOGRAPH DRUG)
Labeler code49967
First marketedDec 2023
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 📄 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 6 words ▾

Use for the treatment of acne

⏱️ Dosage and Administration 109 words ▾

Directions • use every morning and evening • apply a dime-size amount to damp skin and gently massage, avoiding the eye area • rinse well • use wash on entire affected area one to two times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product.

If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active ingredient Benzoyl peroxide 10%

🧪 Inactive Ingredients 57 words ▾

Inactive ingredients water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, , niacinamide, glycolic acid, trideceth-6, triethyl citrate, sodium citrate, sodium hyaluronate, sodium hydroxide, sodium lauroyl lactylate, cholesterol, propanediol, tetrasodium EDTA, caprylyl glycol, diethylhexyl sodium sulfosuccinate, phytosphingosine, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, benzoic acid, PEG-30 dipolyhydroxystearate

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 Do Not Use 14 words ▾

Do not use if you have very sensitive skin are sensitive to benzoyl peroxide

📄 When Using This Product 99 words ▾

When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

📄 Stop Use and Ask a Doctor If 11 words ▾

Stop use and ask a doctor if skin irritation becomes severe

📄 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.

📄 Other Information 10 words ▾

Other information store at 20° - 25°C (68° to 77°F)

📄 Questions or Comments 6 words ▾

Questions or comments? Toll-free number 1-888-768-2915

📄 Package Label / Principal Display Panel 4 words ▾

image of a carton

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epsolay. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Benzoyl peroxide — the ingredient across all brands.

Top reported reactions

Dry Skin1,617
Acne1,576
Erythema1,296
Skin Burning Sensation1,081
Skin Irritation927
Skin Exfoliation620
Pruritus589

Age at onset

Neonate1
Infant1
Child5
Adolescent71
Adult260
Elderly30

Reporter sex

7,972 reports
Male · 23%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization473
Life-threatening139
Disabling65
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,149 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 No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (49967-0604-02). 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.
← 49967-0603-01 · L'Oreal 49967-0606-01 · 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.