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 17 of 56 · 1,101 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Joesoef Skincare Anti AcneSULFURPT Galenium Pharmasia Laboratoriesd9b7acd4-f0dd-c28b-e053-2a95a90a4c302026-01-05WarningsExact identifier
application number: M006
SOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE BODY CLEANSERSOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE BODY CLEANSERPERENNEBELL Co., Ltd.09769ae3-d18a-e2dd-e063-6294a90a1f642026-01-05WarningsExact identifier
application number: M006
PanOxyl Acne Banishing Body (Spray)SALICYLIC ACIDCrown Laboratories, Inc.2305f297-665d-e55f-e063-6394a90aa14e2026-01-05WarningsExact identifier
application number: M006
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENTSALICYLIC ACIDSHISEIDO AMERICAS CORPORATION3b584705-21a8-4e37-96cc-f9c8058db5c42026-01-05WarningsExact identifier
application number: M006
I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSERSALICYLIC ACIDMemebox Corporation297bbe36-23be-0995-e063-6294a90a98df2026-01-01WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.6d7fd1ce-2155-4aa4-87c6-c6fc0c0d3f422026-01-01WarningsExact identifier
application number: M006
Acne Treatment GelSALICYLIC ACIDS+688783fd-574e-40dd-a4cb-c59afdebcddc2025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Acne All-Over Clearing Serum Cleansing SerumSALICYLIC ACIDMelaleuca, Inc.19266ab3-54cd-225d-e063-6294a90aa5122025-12-31WarningsExact identifier
application number: M006
Clarity Clear Skin Solutions Acne Spot TreatmentBENZOYL PEROXIDEMelaleuca, Inc.193667e8-3a4d-9270-e063-6294a90a1c262025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatmentSALICYLIC ACIDMelaleuca, Inc.19370e9a-4907-2ddc-e063-6294a90a97112025-12-31WarningsExact identifier
application number: M006
CLEAR MED 10%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC7acd1404-2af7-4ec4-b1e9-a905c9f823b82025-12-31WarningsExact identifier
application number: M006
CLEAR MED 5%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC03799b2c-cab1-4672-9004-29e4873d022f2025-12-31WarningsExact identifier
application number: M006
SALICYLIC WASHSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC3c6fee91-6f02-40b6-b71f-495b4f235d172025-12-31WarningsExact identifier
application number: M006
SULFUR CALMING MASKSULFURCONTROL CORRECTIVE SKINCARE INC446bd2ea-da88-422a-b086-e61b2d5b62692025-12-31WarningsExact identifier
application number: M006
ACNE SPOT TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC11d47f80-02ae-44a6-acf1-3babb762967b2025-12-31WarningsExact identifier
application number: M006
EXFO TONIC ACNE TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC782867ee-8e38-42fc-bd31-c16e618b01d22025-12-31WarningsExact identifier
application number: M006
THYLOXSULFURBradford Soap Works, Inc.5f52b769-9893-4391-b98f-3765e7b494852025-12-31WarningsExact identifier
application number: M006
AVEDA OUTER PEACE ACNE RELIEF PADSSALICYLIC ACIDAveda Corporationc37052cc-6705-48ff-adf1-0dec7d7360072025-12-31WarningsExact identifier
application number: M006
Acne Care Charcoal CleanserACNE CARE CHARCOAL CLEANSERWhole Foods Market891c09a1-116b-3afd-e053-2995a90a856c2025-12-30WarningsExact identifier
application number: M006
Acne Care MoisturizerACNE CARE MOISTURIZERWhole Foods Market8957fab8-ec9c-2494-e053-2995a90a6c292025-12-30WarningsExact 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