FDA.reportPublic FDA data

Acne Treatment

Product NDC
49035-229
11-digit product format
490350229
Labeler code
49035
Product ID
49035-229_4bd48b57-3411-30fc-e063-6294a90a9f31
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Walmart Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-06
Substance
BENZOYL PEROXIDE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
486131Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
950edb4e-fbba-41e3-9ec5-973806e555e7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-229-10Acne Treatment28 g in 1 TUBEGEL2822
49035-229-10Acne Treatment1 in 1 CARTONGEL122

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
LAURETH-4INACTIVE INGREDIENT6HQ855798JACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-229ACNE TREATMENT (BENZOYL PEROXIDE) GEL [WAL-MART STORES, INC]18Current NDC, Legacy NDC, 2 package rows20241017_950edb4e-fbba-41e3-9ec5-973806e555e7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 23 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Complexion TonerSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a517dfe5-e4a0-5f2d-e053-2a95a90a2ec12025-10-21WarningsExact identifier
application number: M006
Clear Smart Clarifying Cleansing FoamSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a564d38c-d674-29db-e053-2995a90ab3b42025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Pore HydratorSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.dd6e63a6-91d8-41de-9cb7-f88b68c528d02025-10-21WarningsExact identifier
application number: M006
Acne Fighting Putty PrimerSALICYLIC ACIDe.l.f. Cosmetics, Inc657fd325-dd3f-4246-8486-fb5405a52c612025-10-21WarningsExact identifier
application number: M006
Acne Fighting Spot GelSALICYLIC ACIDe.l.f. Cosmetics, Inceca08910-58b9-4ce6-8e97-4b97c30784f52025-10-21WarningsExact identifier
application number: M006
Blemish Control Basics KitSALICYLIC ACIDe.l.f. Cosmetics, Inc1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d22025-10-21WarningsExact identifier
application number: M006
Oil-Free Foaming Acne WashSALICYLIC ACIDRejoice Internationalcfc2efe1-3eb4-4262-ba68-d1201770297c2025-10-20WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Lab Inc.41931e38-0e3c-e322-e063-6394a90af4012025-10-20WarningsExact identifier
application number: M006
Acne WashSALICYLIC ACIDTarget Corporation1c81d366-3bf9-c33e-e063-6294a90a3ca22025-10-18WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.41672e2e-2b70-e879-e063-6294a90a81b02025-10-17WarningsExact identifier
application number: M006
SOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMSOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMPERENNEBELL Co., Ltd.0897ccca-fa18-873f-e063-6394a90a59ab2025-10-16WarningsExact identifier
application number: M006
Acne Calming Water CreamSALICYLIC ACIDe.l.f. Cosmetics, Inc.01b70e53-9e24-4950-bbe9-c58905b6e68d2025-10-15WarningsExact identifier
application number: M006
Acne Clarifying CleanserSALICYLIC ACIDe.l.f. Cosmetics, Inc.0e9be1e3-7fa9-4d70-9c89-cf7501d2380b2025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology9e057f84-0b46-4ffc-a3bb-5bafc8f6baa52025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology1c2d71c5-2560-462f-adec-14bc38550ba42025-10-15WarningsExact identifier
application number: M006
Purifying Clay MaskSALICYLIC ACIDCosmetic Enterprises Ltdd17e3ff5-f7a4-3e14-e053-2995a90a22b22025-10-14WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486131benzoyl peroxide 10 % Topical GelPSN950edb4e-fbba-41e3-9ec5-973806e555e722
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD950edb4e-fbba-41e3-9ec5-973806e555e722
486131benzoyl peroxide 10 % Topical GelSY950edb4e-fbba-41e3-9ec5-973806e555e722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-229-10490350229101 TUBE in 1 CARTON (49035-229-10) / 28 g in 1 TUBE1 tube2015-01-060000-00-00NoNoCurrent