Home › NDC Lookup › Ingredients › Benzoyl Peroxide › 49527-0117-01
ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT BENZOYL PEROXIDE 25 mg/mL Lotion — NDC 49527-0117-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT BENZOYL PEROXIDE 25 mg/mL Lotion — NDC 49527-117-01 (Billing 49527-0117-01)

by CLINIQUE LABORATORIES LLC · 1 TUBE in 1 CARTON / 50 mL in 1 TUBE

This is a package of ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT BENZOYL PEROXIDE 25 mg/mL Lotion from CLINIQUE LABORATORIES LLC, 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 3 package sizes.

NDC 49527-0117-01
🏷️ FDA NDC (as labeled) 49527-117-01 billing pads the product segment with a zero
This package
Contains50 mL in 1 tube Pack sizes3 compare ↓
Main listing for product 49527-117 · Also comes in: 30 mL 49527-117-02 15 mL 49527-117-03
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ 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

⚠️
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. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. 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) 49527-117-01
Product NDC 49527-117
11-digit billing NDC 49527011701
RxCUI 200009
UNII W9WZN9A0GM
UPC 0020714291839
Application # M006
SPL Set ID 0d0cfec0-5d18-c347-e063-6394a90a912c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2023-12-21
Route TOPICAL
Dosage form LOTION
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 200009
Why two NDCs? The FDA registers this code as 49527-117-01 — 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 → 49527-0117-01. 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: 30 mL 15 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
49527-0117-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 50 mL in 1 TUBE 2023-12-21 — Inactivated by FDA
49527-0117-02 49527-117-02 1 TUBE in 1 CARTON / 30 mL in 1 TUBE 2023-12-21 — Inactivated by FDA
49527-0117-03 49527-117-03 1 TUBE in 1 CARTON / 15 mL in 1 TUBE 2023-12-21 — Inactivated by FDA

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 50 ml in 1 tube.
What NDC number is used to bill for this package of ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT BENZOYL PEROXIDE 25 mg/mL Lotion?
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
Walgreens Acne Spot Treatment 25 mg/g 00363-0116-51 WALGREEN 1 tube — — FDA listed —
Oxy Total Care Clarifying Moisturizer 25 mg/mL 10742-1314-01 The 1 tube — — FDA listed —
Target Up and Up Acne Spot Treatment 25 mg/g 11673-0149-51 TARGET 1 tube — — FDA listed —
SPOTLESS Acne Clearing Treatment .025 g/mL 14222-1620-01 Rodan 1 bottle — — FDA listed —
UNBLEMISH Dual Intensive Acne Treatment .025 g/mL 14222-2120-01 Rodan 1 bottle — — FDA listed —
Acne Solutions All-Over Clearing Treatment 25 mg/mLthis 49527-0117-01 CLINIQUE 1 tube — — Discontinued —
Clearogen 3 2.5 g/100g 62742-4238-01 Allure 55 g — — FDA listed —
SkinPharmacy Advanced Acne Therapy Active Clearing 25 mg/mL 69842-0076-01 CVS 1 tube — — FDA listed —
amazon basics step 3 treatment Acne medication 25 mg/mL 72288-0618-01 AMAZON.COM 60 ml — — FDA listed —
Benzoyl Peroxide Acne 25 mg/g 73318-7006-01 Skin 1 bottle — — FDA listed —
Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes 25 mg/mL 68634-0068-01 AMCOL 2 packets — — FDA listed —
SkinPharmacy Advanced Acne Therapy Targeted Treatment Wipes 25 mg/mL 69842-0081-01 CVS 2 packets — — FDA listed —
Acne Face and Body 25 mg/mL 70707-0101-06 Face 180 ml — — FDA listed —
Acne Med 2.5% 25 mg/mL 70707-0200-15 Face 1 bottle — — FDA listed —
Acne Face and Body Wash 25 mg/mL 70707-0711-06 Face 180 ml — — FDA listed —
2.5 Acne Med 25 mg/mL 70707-0152-15 Face 1 tube — — FDA listed —
MDacne Customized Acne Treatment Benzoyl Peroxide 25 mg/mL 71804-0531-00 MDAlgorithms 1 tube — — FDA listed —
Face Reality Advanced Acne Med 25 mg/mL 70707-0156-01 Face 1 tube — — FDA listed —
amazon basics step 1 cleanser Acne treatment 25 mg/mL 72288-0120-01 AMAZON.COM 120 ml — — 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio61 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.

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
🎯 Indications and Usage 13 words ▾

Uses Treats Acne Clears acne blemishes Helps prevent development of new acne blemishes

⏱️ Dosage and Administration 105 words ▾

Directions DIRECTIONS: CLEANS SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE 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 DOY OR EVERY OTHER DAY IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION

⚠️ Warnings 141 words ▾

WARNING: FOR EXTERNAL USE ONLY DO NOT USE IF YOU HAVE VERY SENSITIVE SKIN ARE SENSITIVE TO BENZOYL PEROXIDE WHEN USING THIS PRODUCT SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT 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 IRRITATION BECOMES SEVERE KEEP OUT OF REACH OF CHILDREN IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%

🧪 Inactive Ingredients 55 words ▾

Inactive ingredients water\aqua\eau∙cyclopentasiloxane∙butylene glycol∙cyclohexasiloxane∙ceteareth-20∙dimethicone∙sucrose∙camellia sinensis (green tea) leaf extract∙hordeum vulgare (barley) extract\extrait d'orge∙acetyl glucosamine∙lactobacillus ferment∙poria cocos sclerotium extract∙polymethyl methacrylate∙laminaria saccharina extract∙gentiana lutea (gentian) root extract∙astrocaryum murumuru seed butter∙acrylamide/sodium acryloyldimethyltaurate copolymer∙myristyl alcohol∙glycerin∙zeolite∙algae extract∙linoleic acid∙10-hydroxydecanoic acid∙cucumis sativus (cucumber) fruit extract∙caffeine∙ cholesterol∙tocopheryl acetate∙bisabolol∙polysorbate 80∙sodium hyaluronate∙propylene glycol dicaprate∙capryloyl glycine∙helianthus annuus (sunflower) seed extract∙quaternium-22∙caprylyl glycol∙isohexadecane∙xanthan gum∙disodiumedta∙chloroxylenol∙phenoxyethanol∙titanium dioxide (ci 77891) [iln47611]

🎯 Purpose 3 words ▾

Purpose Acne Treatment

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
Death61
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,318 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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 2 other package presentations of this same product, including 1 tube (49527-0117-02), 1 tube (49527-0117-03). 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?
CLINIQUE LABORATORIES LLC 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.
← 49527-0116-01 · CLINIQUE 49527-0118-01 · CLINIQUE →
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.