topcare earwax removal kit

Generic: carbamide peroxide

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare earwax removal kit
Generic Name carbamide peroxide
Labeler topco associates llc
Dosage Form LIQUID
Routes
AURICULAR (OTIC)
Active Ingredients

carbamide peroxide 65 mg/mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-835
Product ID 36800-835_2f394074-9ba2-6dff-e063-6294a90a2cad
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2026-12-31
Marketing Start 2014-11-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800835
Hyphenated Format 36800-835

Supplemental Identifiers

RxCUI
702050
UPC
0036800776913
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 topcare earwax removal kit (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, DISPENSING in 1 CARTON (36800-835-33) / 15 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

36800-835-33 1 BOTTLE, DISPENSING in 1 CARTON (36800-835-33) / 15 mL in 1 BOTTLE, DISPENSING

Ingredients (1)

carbamide peroxide (65 mg/mL)

Linked Drug Pages (1)

TopCare Earwax Removal Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "2f394074-9ba2-6dff-e063-6294a90a2cad", "openfda": {"upc": ["0036800776913"], "unii": ["31PZ2VAU81"], "rxcui": ["702050"], "spl_set_id": ["890cc9b6-41a5-480a-bc94-45c8d4fdeef3"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DISPENSING in 1 CARTON (36800-835-33)  / 15 mL in 1 BOTTLE, DISPENSING", "package_ndc": "36800-835-33", "marketing_start_date": "20141128"}], "brand_name": "TopCare Earwax Removal Kit", "product_id": "36800-835_2f394074-9ba2-6dff-e063-6294a90a2cad", "dosage_form": "LIQUID", "product_ndc": "36800-835", "generic_name": "CARBAMIDE PEROXIDE", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Earwax Removal Kit", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "65 mg/mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141128", "listing_expiration_date": "20261231"}