carbamide peroxide 6.5%

Generic: earwax removal kit

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name carbamide peroxide 6.5%
Generic Name earwax removal kit
Labeler allegiant health
Dosage Form SOLUTION/ DROPS
Routes
AURICULAR (OTIC)
Active Ingredients

carbamide peroxide 65 mg/mL

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-488
Product ID 69168-488_4f1c9234-6bb1-4795-af84-731f628424db
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2027-12-31
Marketing Start 2025-10-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69168488
Hyphenated Format 69168-488

Supplemental Identifiers

RxCUI
702050
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 carbamide peroxide 6.5% (source: ndc)
Generic Name earwax removal kit (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 (69168-488-68) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

69168-488-68 1 BOTTLE, DROPPER in 1 CARTON (69168-488-68) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

carbamide peroxide (65 mg/mL)

Linked Drug Pages (1)

Carbamide peroxide 6.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "4f1c9234-6bb1-4795-af84-731f628424db", "openfda": {"unii": ["31PZ2VAU81"], "rxcui": ["702050"], "spl_set_id": ["54515e9d-2225-4875-a1cf-a24a823300dd"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69168-488-68)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "69168-488-68", "marketing_start_date": "20251028"}], "brand_name": "Carbamide peroxide 6.5%", "product_id": "69168-488_4f1c9234-6bb1-4795-af84-731f628424db", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "69168-488", "generic_name": "Earwax Removal Kit", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Carbamide peroxide 6.5%", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "65 mg/mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251028", "listing_expiration_date": "20271231"}