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

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 Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui486131

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

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