FDA.reportPublic FDA data

Benzoyl Peroxide

Product NDC
35573-453
Requested package NDC
35573-453-91
11-digit product format
355730453
Labeler code
35573
Product ID
35573-453_d51a6f4b-982d-45aa-932f-a9527b294289
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Burel Pharmaceuticals, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-15
Substance
BENZOYL PEROXIDE
Active strength
50 mg/mL
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 PEROXIDE50 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
142034Internal RxNorm lookup
308696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0617d42d-511d-4c1a-a919-b37abbc14efcAvailable 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
35573-453-08Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374
35573-453-91Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-453-08GM - Gram35573-453d0e87e69-f9fd-4531-8f3e-3f66ba15c32c12022-05-04
35573-453-91GM - Gram35573-45394c86177-2ec0-430d-b536-aba227bfa74012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-453BENZOYL PEROXIDE LIQUID [BUREL PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240726_0617d42d-511d-4c1a-a919-b37abbc14efc.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 18 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHA/BHA SwipesRESURFACING TREATMENT PADSSKIN PS Brands02601602-badc-f18d-e063-6394a90a40062025-12-30WarningsExact identifier
application number: M006
BP Body WashBODY WASHSkin PS Brands0754b6b1-3a62-a95a-e063-6394a90a92292025-12-30WarningsExact identifier
application number: M006
Benzoyl Peroxide AcneACNE LOTIONSkin PS Brands0792f466-f19c-acf0-e063-6294a90a6f912025-12-30WarningsExact identifier
application number: M006
Blemish Spot TreatmentSALICYLIC ACIDSkin Script, LLC1bf92da8-35bf-5f32-e063-6294a90a71cf2025-12-29WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC1e142db9-c53c-db03-e063-6394a90a9d6e2025-12-23WarningsExact identifier
application number: M006
CAUDALIE Vinopure Acne SerumSALICYLIC ACIDCaudalie USA Inc.266ba6e3-5450-e9a9-e063-6394a90ab8f42025-12-22WarningsExact identifier
application number: M006
Cocokind postbiotic acne serumSALICYLIC ACID 1.5%Onekind.25d541dcee-fbed-9ffc-e053-2a95a90a43ae2025-12-22WarningsExact identifier
application number: M006
Juananan SALICYLIC ACID ESSENCESALICYLIC ACIDShanghai Zhulu Biotechnology Co., Ltd46623a3e-37bf-3ee4-e063-6294a90ae60d2025-12-21WarningsExact identifier
application number: M006
Breakout Clearing BoosterSALICYLIC ACIDDermalogica, LLC.6ec73c30-a5cc-4937-aa7e-714f53ef24082025-12-18WarningsExact identifier
application number: M006
BP WashBENZOYL PEROXIDECINTEX SERVICES, LLCfd7560ce-5e52-4ba8-b52c-82500611818a2025-12-18WarningsExact identifier
application number: M006
BP WashBENZOYL PEROXIDECINTEX SERVICES, LLCfc69294e-80d4-427f-a0f7-70cecda136da2025-12-18WarningsExact identifier
application number: M006
BP WashBENZOYL PEROXIDECINTEX SERVICES, LLCe26c5cad-1ae6-48f0-abf4-02a01c79538c2025-12-18WarningsExact identifier
application number: M006
First Aid Beauty FAB Pharma White Clay Acne TreatmentSALICYLIC ACIDThe Procter & Gamble Manufacturing Companybeb14aca-eede-6113-e053-2a95a90a02742025-12-18WarningsExact identifier
application number: M006
First Aid Beauty FAB Acne Spot TreatmentSALICYLIC ACIDThe Procter & Gamble Manufacturing Company018e4aad-2e37-d7e9-e063-6394a90a9de22025-12-18WarningsExact identifier
application number: M006
Ambi Even and Clean Skin Tone KitSALICYLIC ACIDAmbi Enterprise LLC46437434-c583-2e7f-e063-6394a90a3ab32025-12-18WarningsExact identifier
application number: M006
clear days ahead oil-free salicylic acid acne treatment cleanserSALICYLIC ACIDPhilosophy Inc.e76dfe48-db23-47e9-8f86-640c9c7bc2a42025-12-17WarningsExact identifier
application number: M006
clear days ahead oil-free salicylic acid acne treatment and moisturizerSALICYLIC ACIDPhilosophy Inc.d7895387-100c-4cc4-9c25-0f3b9d0f59372025-12-17WarningsExact identifier
application number: M006
clear days ahead overnight repair salicylic acid acne treatment padsSALICYLIC ACIDPhilosophy Inc.741c6f90-2e32-4700-bb9f-d30329bd3dc32025-12-17WarningsExact identifier
application number: M006
clear days ahead fast-acting salicylic acid acne spot treatmentSALICYLIC ACIDPhilosophya61d0f78-9759-4085-b5e5-577d349be9fd2025-12-17WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLBioelements, Inc21ca8de4-28b5-425f-e063-6394a90a33402025-12-17WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN0617d42d-511d-4c1a-a919-b37abbc14efc4
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN0617d42d-511d-4c1a-a919-b37abbc14efc4
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD0617d42d-511d-4c1a-a919-b37abbc14efc4
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD0617d42d-511d-4c1a-a919-b37abbc14efc4
142034benzoyl peroxide 10 % Medicated Liquid SoapSY0617d42d-511d-4c1a-a919-b37abbc14efc4
308696benzoyl peroxide 5 % Medicated Liquid SoapSY0617d42d-511d-4c1a-a919-b37abbc14efc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-453-9135573045391148 mL in 1 BOTTLE (35573-453-91) 148 ml2022-04-150000-00-00NoNoCurrent