benzoyl peroxide

Generic: benzoyl peroxide

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name benzoyl peroxide
Generic Name benzoyl peroxide
Labeler burel pharmaceuticals, llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzoyl peroxide 50 mg/mL

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-453
Product ID 35573-453_d51a6f4b-982d-45aa-932f-a9527b294289
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M006
Listing Expiration 2026-12-31
Marketing Start 2022-04-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573453
Hyphenated Format 35573-453

Supplemental Identifiers

RxCUI
142034 308696
UPC
0335573454081 0335573454913
UNII
W9WZN9A0GM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benzoyl peroxide (source: ndc)
Generic Name benzoyl peroxide (source: ndc)
Application Number M006 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (35573-453-08)
  • 148 mL in 1 BOTTLE (35573-453-91)
source: ndc

Packages (2)

35573-453-08 237 mL in 1 BOTTLE (35573-453-08) 35573-453-91 148 mL in 1 BOTTLE (35573-453-91)

Ingredients (1)

benzoyl peroxide (50 mg/mL)

Linked Drug Pages (1)

Benzoyl Peroxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d51a6f4b-982d-45aa-932f-a9527b294289", "openfda": {"upc": ["0335573454081", "0335573454913"], "unii": ["W9WZN9A0GM"], "rxcui": ["142034", "308696"], "spl_set_id": ["0617d42d-511d-4c1a-a919-b37abbc14efc"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (35573-453-08)", "package_ndc": "35573-453-08", "marketing_start_date": "20220415"}, {"sample": false, "description": "148 mL in 1 BOTTLE (35573-453-91)", "package_ndc": "35573-453-91", "marketing_start_date": "20220415"}], "brand_name": "Benzoyl Peroxide", "product_id": "35573-453_d51a6f4b-982d-45aa-932f-a9527b294289", "dosage_form": "LIQUID", "product_ndc": "35573-453", "generic_name": "Benzoyl Peroxide", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Benzoyl Peroxide", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "50 mg/mL"}], "application_number": "M006", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220415", "listing_expiration_date": "20261231"}