ear drops major
Generic: carbamide peroxide 6.5%
Labeler: major pharmaceuticalsDrug Facts
Product Profile
Brand Name
ear drops major
Generic Name
carbamide peroxide 6.5%
Labeler
major pharmaceuticals
Dosage Form
LIQUID
Routes
Active Ingredients
carbamide peroxide 6.5 g/100mL
Manufacturer
Identifiers & Regulatory
Product NDC
0904-6627
Product ID
0904-6627_3afc65d5-4dbc-d1c5-e063-6294a90a41d6
Product Type
HUMAN OTC DRUG
Marketing Category
OTC MONOGRAPH DRUG
Application Number
M014
Marketing Start
2019-10-10
Marketing End
2026-09-30
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
09046627
Hyphenated Format
0904-6627
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
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 drops major (source: ndc)
Generic Name
carbamide peroxide 6.5% (source: ndc)
Application Number
M014 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 6.5 g/100mL
Packaging
- 1 BOTTLE in 1 CARTON (0904-6627-35) / 15 mL in 1 BOTTLE
Packages (1)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["AURICULAR (OTIC)"], "spl_id": "3afc65d5-4dbc-d1c5-e063-6294a90a41d6", "openfda": {"unii": ["31PZ2VAU81"], "rxcui": ["702050"], "spl_set_id": ["ad8bce05-6be4-4f6c-9341-bce7c3aa05cf"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6627-35) / 15 mL in 1 BOTTLE", "package_ndc": "0904-6627-35", "marketing_end_date": "20260930", "marketing_start_date": "20191010"}], "brand_name": "Ear Drops Major", "product_id": "0904-6627_3afc65d5-4dbc-d1c5-e063-6294a90a41d6", "dosage_form": "LIQUID", "product_ndc": "0904-6627", "generic_name": "Carbamide Peroxide 6.5%", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ear Drops", "brand_name_suffix": "Major", "active_ingredients": [{"name": "CARBAMIDE PEROXIDE", "strength": "6.5 g/100mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260930", "marketing_start_date": "20191010"}