auralyt

Generic: carbamide peroxide

Labeler: menper distributors, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name auralyt
Generic Name carbamide peroxide
Labeler menper distributors, inc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

carbamide peroxide 7.8 mg/12mL

Manufacturer
Menper Distributors, Inc

Identifiers & Regulatory

Product NDC 53145-311
Product ID 53145-311_3a8ad090-e1c6-7ea7-e063-6394a90a6ffc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2026-12-31
Marketing Start 2014-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53145311
Hyphenated Format 53145-311

Supplemental Identifiers

UPC
0042279104010
UNII
31PZ2VAU81

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 auralyt (source: ndc)
Generic Name carbamide peroxide (source: ndc)
Application Number M014 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 7.8 mg/12mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

53145-311-04 1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER

Ingredients (1)

carbamide peroxide (7.8 mg/12mL)

Linked Drug Pages (1)

Auralyt ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3a8ad090-e1c6-7ea7-e063-6394a90a6ffc", "openfda": {"upc": ["0042279104010"], "unii": ["31PZ2VAU81"], "spl_set_id": ["95920b87-941f-48cb-850c-40d2735596d4"], "manufacturer_name": ["Menper Distributors, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (53145-311-04)  / 12 mL in 1 BOTTLE, DROPPER", "package_ndc": "53145-311-04", "marketing_start_date": "20140101"}], "brand_name": "Auralyt", "product_id": "53145-311_3a8ad090-e1c6-7ea7-e063-6394a90a6ffc", "dosage_form": "LIQUID", "product_ndc": "53145-311", "generic_name": "Carbamide Peroxide", "labeler_name": "Menper Distributors, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Auralyt", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "7.8 mg/12mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140101", "listing_expiration_date": "20261231"}