ear wax removal drops

Generic: carbamide peroxide - 6.5%

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

Drug Facts

Product Profile

Brand Name ear wax removal drops
Generic Name carbamide peroxide - 6.5%
Labeler sheffield pharmaceuticals llc
Dosage Form SOLUTION/ DROPS
Routes
TOPICAL
Active Ingredients

carbamide peroxide 65 mg/mL

Manufacturer
Sheffield Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 11527-143
Product ID 11527-143_184c7110-33c6-4b58-bc79-451870131f3a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2026-12-31
Marketing Start 2017-02-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11527143
Hyphenated Format 11527-143

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 ear wax removal drops (source: ndc)
Generic Name carbamide peroxide - 6.5% (source: ndc)
Application Number M014 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 65 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (11527-143-51) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

11527-143-51 1 BOTTLE, DROPPER in 1 CARTON (11527-143-51) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

carbamide peroxide (65 mg/mL)

Linked Drug Pages (1)

Ear Wax Removal Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "184c7110-33c6-4b58-bc79-451870131f3a", "openfda": {"unii": ["31PZ2VAU81"], "rxcui": ["702050"], "spl_set_id": ["aad7e2cd-cb28-423c-a441-eabe6516d40f"], "manufacturer_name": ["Sheffield Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (11527-143-51)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "11527-143-51", "marketing_start_date": "20170202"}], "brand_name": "Ear Wax Removal Drops", "product_id": "11527-143_184c7110-33c6-4b58-bc79-451870131f3a", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "11527-143", "generic_name": "Carbamide Peroxide - 6.5%", "labeler_name": "Sheffield Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ear Wax Removal Drops", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "65 mg/mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170202", "listing_expiration_date": "20261231"}