debrox

Generic: carbamide peroxide

Labeler: medtech products inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name debrox
Generic Name carbamide peroxide
Labeler medtech products inc.
Dosage Form LIQUID
Routes
AURICULAR (OTIC)
Active Ingredients

carbamide peroxide 65 mg/mL

Manufacturer
Medtech Products Inc.

Identifiers & Regulatory

Product NDC 63029-321
Product ID 63029-321_69ef758d-a912-4696-8f5e-ac6cd1aa63dc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2026-12-31
Marketing Start 2012-08-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63029321
Hyphenated Format 63029-321

Supplemental Identifiers

RxCUI
702050 827654
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 debrox (source: ndc)
Generic Name carbamide peroxide (source: ndc)
Application Number M014 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 65 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63029-321-01) / 15 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (63029-321-02) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

63029-321-01 1 BOTTLE, DROPPER in 1 CARTON (63029-321-01) / 15 mL in 1 BOTTLE, DROPPER 63029-321-02 1 BOTTLE, DROPPER in 1 CARTON (63029-321-02) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

carbamide peroxide (65 mg/mL)

Linked Drug Pages (1)

DEBROX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "69ef758d-a912-4696-8f5e-ac6cd1aa63dc", "openfda": {"unii": ["31PZ2VAU81"], "rxcui": ["702050", "827654"], "spl_set_id": ["43649ba3-75e0-4dcf-9172-23767dbaeda6"], "manufacturer_name": ["Medtech Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63029-321-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "63029-321-01", "marketing_start_date": "20120801"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63029-321-02)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "63029-321-02", "marketing_start_date": "20120801"}], "brand_name": "DEBROX", "product_id": "63029-321_69ef758d-a912-4696-8f5e-ac6cd1aa63dc", "dosage_form": "LIQUID", "product_ndc": "63029-321", "generic_name": "Carbamide Peroxide", "labeler_name": "Medtech Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DEBROX", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "65 mg/mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120801", "listing_expiration_date": "20261231"}