benzoyl peroxide

Product NDC
45802-101
11-digit product format
458020101
Labeler code
45802
Product ID
45802-101_eae4cff7-3c1c-429e-85ec-ba5f2075562b
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
2012-03-13
Substance
BENZOYL PEROXIDE
Active strength
2.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
benzoyl peroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE2.5 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
308689Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ba5e88c-a4d5-4550-93fa-d3d7fee45f9fAvailable 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
45802-101-96benzoyl peroxide60 g in 1 TUBEGEL606
45802-101-96benzoyl peroxide1 in 1 CARTONGEL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-101-96GM - Gram45802-10148510c17-3c75-4ad5-8775-590738a9cfc612013-02-13

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
45802-101BENZOYL PEROXIDE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 2 package rows20241025_0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f.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 28 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Stubborn Acne AM TreatmentBENZOYL PEROXIDEKenvue Brands LLCd6e05b11-8c5f-490d-a5d8-116dcc895cb82025-06-04WarningsExact identifier
application number: M006
TULA SKINCARE BREAKOUT BREAKTHROUGH ACNE TONER PADSSALICYLIC ACIDThe Procter & Gamble Manufacturing Company36ada73d-cfc5-d4a4-e063-6294a90a7c732025-06-03WarningsExact identifier
application number: M006
Psoriasis Body WashCOLLOIDAL OATMEALRida LLC4b2bba1b-7e7b-4397-9eb4-d94c44b983142025-06-03WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.4058327e-2764-4df0-9d5d-7cda72d9ca412025-06-02WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd3640d29e-7e4c-b3be-e063-6394a90a0d9e2025-05-29WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC36412939-97bc-6cb1-e063-6294a90aef482025-05-29WarningsExact identifier
application number: M006
Tula Skincare Clear It Up Acne Clearing and Tone Correcting GelSALICYLIC ACIDThe Procter & Gamble Manufacturing Company364a96fb-67fe-eeb7-e063-6394a90aa60c2025-05-29WarningsExact identifier
application number: M006
Psoriasis Scalp TreatmentSALICYLIC ACIDRida LLC14ab77e7-86b0-49d3-8efa-8a80c5a24d742025-05-28WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Foaming CleanserSALICYLIC ACIDKenvue Brands LLCec136786-9d46-a022-e053-2a95a90a07522025-05-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Body Acne Cleanser and ExfoliatorSALICYLIC ACIDKenvue Brands LLCdd13b492-5c82-a7d0-e053-2a95a90a62b32025-05-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Texture Daily CleanserSALICYLIC ACIDKenvue Brands LLCef2d9cd5-5c6c-4839-af5d-6bc21187b1322025-05-26WarningsExact identifier
application number: M006
NAELI Exfoliator AHA-BHA Face CleanserSALICYLIC ACIDALLI LLC16bf50c6-4a9d-4242-94a2-d2165b82e7ce2025-05-22WarningsExact identifier
application number: M006
First Aid Beauty Acne Clearing PadsSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35bd600b-5da6-5225-e063-6294a90ac6f32025-05-22WarningsExact identifier
application number: M006
First Aid Beauty Body Acne Clearing MistSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35be1450-01c1-1668-e063-6394a90af9b52025-05-22WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC353ed0a4-dcae-7748-e063-6294a90ac3f72025-05-16WarningsExact identifier
application number: M006
Dickinsons Original Witch Hazel Exfoliating Bubble TonerSALICYLIC ACIDDickinson Brands Inc.5a5119a2-d6ca-4932-9df6-faed97e1d2a12025-05-16WarningsExact identifier
application number: M006
Earths Care Acne Spot TreatmentSULFURDLC Laboratories, Inc.85dab75e-5436-4e31-9ce2-c1995fde1dd92025-05-15WarningsExact identifier
application number: M006
Neutrogena On-the-Spot Acne Treatment Vanishing FormulaBENZOYL PEROXIDEKenvue Brands LLC7cc8f53d-b8e3-4711-a1d3-fd43be35af512025-05-12WarningsExact identifier
application number: M006
Biome-Balancing Clear and Prevent Acne (Blemish) Treatment SerumSALICYLIC ACIDMurad, LLC3709208a-5550-4819-b923-a883878737bb2025-05-05WarningsExact identifier
application number: M006
MY BEAUTY SPOT Day and Night Acne PatchSALICYLIC ACIDMELON BIO-TECH (THAILAND) CO., LTD.6e4ab3d3-378e-40e5-a6a5-66090edcfda82025-04-28WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f6
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f6
308689benzoyl peroxide 2.5 % Topical GelSY0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-101-96458020101961 TUBE in 1 CARTON (45802-101-96) / 60 g in 1 TUBE1 tube2012-03-130000-00-00NoNoCurrent