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 51 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic AcidSALICYLIC ACIDNew Milani Group, LLCc2d43609-8a7a-4e54-8e8c-66115948dba22023-12-12WarningsExact identifier
application number: M006
Differin Daily Deep Cleanser with BPOBENZOYL PEROXIDEGalderma Laboratories, L.P.192b231b-51f1-457c-9a82-ef75671c0d342023-12-11WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incaa439d77-7ba5-4699-8e8b-3bba35f5094d2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION04df2f5d-77f0-4553-9d8c-3f10628736ae2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Inc4acae53c-3250-4703-83ac-f158562926c62023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body ScrubSALICYLIC ACIDGalderma Laboratories, L.P.b1e9f483-80ad-49f1-974e-4732bacd96392023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Daily Deep CleansingSALICYLIC ACIDL'Oreal USA Products Inc0db3a8cb-7691-4772-9f7d-15de66098e2e2023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body WashSALICYLIC ACIDGalderma Laboratories, L.P.b280351f-02d4-4456-85b5-905e835968482023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing BodySALICYLIC ACIDGalderma Laboratories, L.P.ce4d1074-5f74-4ad7-9535-2737f5fff24f2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Incb7d0d094-6a5b-4776-9f13-1f8d305424762023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Deep CleansingSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb61a3f74-a588-47f4-b4a5-c8f97f98d9dd2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incc6f5e9a4-c938-4c44-ace7-a9688b227d592023-12-11WarningsExact identifier
application number: M006
Clarifying TonerSALICYLIC ACIDAllure Labs0c07e6e9-18c1-20da-e063-6294a90aa3c82023-12-08WarningsExact identifier
application number: M006
Acne Advanced Clarifying HydratorSALICYLIC ACIDEminence Organic Skin Care Ltd.b710cc36-f589-4116-a0a2-c6966ebebbf22023-12-08WarningsExact identifier
application number: M006
Foaming CleanserSALICYLIC ACIDAllure Labs0bf4c2d8-2fbf-a1c4-e063-6294a90ac1302023-12-07WarningsExact identifier
application number: M006
CLEAROGEN 3BENZOYL PEROXIDEAllure Labs0bdf9f38-5763-a4d0-e063-6394a90a41dc2023-12-06WarningsExact identifier
application number: M006
REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOEBENZOYL PEROXIDETopiderm, Inc.ea9a32c4-3795-4718-9394-bac69091c7322023-12-04WarningsExact identifier
application number: M006
Acne Advanced Treatment SystemSALICYLIC ACIDEminence Organic Skin Care Ltd.9acf53a6-10f1-470d-b270-3a0203cf89c02023-12-02WarningsExact identifier
application number: M006
Cetaphil Gentle Clear BPO Acne CleanserBENZOYL PEROXIDEGalderma Laboratories, L.P.6397f20f-d69f-47e4-a123-4cc7e1abfcad2023-11-29WarningsExact 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