FDA.reportPublic FDA data

benzoyl peroxide

Product NDC
45802-308
11-digit product format
458020308
Labeler code
45802
Product ID
45802-308_560798ff-c57f-4c10-82d8-f69fb0d7839f
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-06
Substance
BENZOYL PEROXIDE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
benzoyl peroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE10 g/100g

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
9702add4-ea36-4c6b-9402-87b44f989a80Available 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
45802-308-01benzoyl peroxide1 in 1 CARTONGEL15
45802-308-01benzoyl peroxide90 g in 1 TUBEGEL905
45802-308-96benzoyl peroxide60 g in 1 TUBEGEL605
45802-308-96benzoyl peroxide1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-308-01GM - Gram45802-30847c6660c-9632-470b-a9af-62134dc9cd8912013-02-13
45802-308-96GM - Gram45802-3087215f6f5-0655-4756-b752-28b0fc82d79912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
DISODIUM LAURYL SULFOSUCCINATEINACTIVE INGREDIENTP160Q81342BENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
POLOXAMER 182INACTIVE INGREDIENTJX0HIX6OAGBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZOYL PEROXIDE GEL [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-308BENZOYL PEROXIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 4 package rows20241025_9702add4-ea36-4c6b-9402-87b44f989a80.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 1 of 55 · 1,096 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-08-13WarningsExact identifier
application number: M006
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58d245c3-c685-5784-e063-6294a90a1e232026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.66e0a0a5-22b5-4c89-a949-e996071a585b2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.13b5a729-e265-47fd-b082-2557805d08bc2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.9339d7ed-6e8a-48d2-a5dd-76d395e8d2652026-08-12WarningsExact identifier
application number: M006
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
application number: M006
CLERIVY MICRODART ACNESALICYLIC ACIDGuhada Co., Ltd.555e0963-025e-3731-e063-6394a90a679d2026-08-11WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEMalezia LLCb1304464-bd7e-fb5d-e053-2995a90a54c42026-08-11WarningsExact identifier
application number: M006
SUZANOBAGIMD Acne Cleansing WipesSALICYLIC ACIDObagi Cosmeceuticals LLC91517c5a-1653-41f3-8dfb-a9dea620765c2026-08-10WarningsExact identifier
application number: M006
APUREE Prorevive Maximum Strength AntifungalCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.58860baa-070a-7b73-e063-6294a90acdf02026-08-08WarningsExact identifier
application number: M006
DG Health Athletes FootTOLNAFTATEDolgencorp, LLC42eb14a8-d5e0-42e1-a5a2-3f65bbfa6f3f2026-08-07WarningsExact identifier
application number: M006
Acne Control CleanserSALICYLIC ACIDCVS Health07cb1c7c-5188-49d5-916e-e2161b5ca3b02026-08-06WarningsExact identifier
application number: M006
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486131benzoyl peroxide 10 % Topical GelPSN9702add4-ea36-4c6b-9402-87b44f989a805
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD9702add4-ea36-4c6b-9402-87b44f989a805
486131benzoyl peroxide 10 % Topical GelSY9702add4-ea36-4c6b-9402-87b44f989a805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-308-01458020308011 TUBE in 1 CARTON (45802-308-01) / 90 g in 1 TUBE1 tube2012-04-130000-00-00NoNoCurrent
45802-308-96458020308961 TUBE in 1 CARTON (45802-308-96) / 60 g in 1 TUBE1 tube2016-04-060000-00-00NoNoCurrent