Ear Drops

Product NDC: 0904-6627
11-digit product format: 009046627
Labeler code: 0904
Product ID: 0904-6627_3afc65d5-4dbc-d1c5-e063-6294a90a41d6
Type: HUMAN OTC DRUG
Nonproprietary name: Carbamide Peroxide 6.5%
Dosage form: LIQUID
Route: AURICULAR (OTIC)
Labeler: Major Pharmaceuticals
Application: M014
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-10
Marketing end: 2026-09-30
Substance: CARBAMIDE PEROXIDE
Active strength: 6.5 g/100mL
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Ear Drops
Brand name suffix: Major

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMIDE PEROXIDE	6.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
31PZ2VAU81	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
702050	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ad8bce05-6be4-4f6c-9341-bce7c3aa05cf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6627-35	Ear DropsMajor	1 in 1 CARTON	LIQUID	1		7
0904-6627-35	Ear DropsMajor	15 mL in 1 BOTTLE	LIQUID	15		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6627-35	ML - Milliliter	0904-6627	961d332f-97a9-4b3c-bf08-36c272f44857	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6627	EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20231215_ad8bce05-6be4-4f6c-9341-bce7c3aa05cf.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EarBalance Ear Pain Drops	LIDOCAINE HYDROCHLORIDE OTIC SOLUTION	Marie's Original Formulas LLC	54dc3642-0b7a-07d8-e063-6294a90ad556	2026-07-22	Warnings	Exact identifier application number: M014
EarBalance Ear Pain Drops	LIDOCAINE HYDROCHLORIDE OTIC SOLUTION	Marie's Original Formulas LLC	55057e1b-b11e-51b9-e063-6394a90a9fca	2026-07-22	Warnings	Exact identifier application number: M014
Macks Dry n Clear	EAR DRYING AID	McKeon Products Inc	1ea1da54-2412-c25c-e063-6294a90aa264	2026-06-26	Warnings	Exact identifier application number: M014
Equate Swimmers Instant Ear Dry	EQUATE SWIMMERS INSTANT EAR DRY	Walmart Stores, Inc	76b58a7a-48cf-866c-e053-2a91aa0a7e63	2026-06-26	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Drops Earwax Removal Aid	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	c68b40d9-c1d4-4425-8063-50c00299e718	2026-06-10	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	b2a641da-e070-4223-b836-5ca9ffb89f3f	2026-06-10	Warnings	Exact identifier application number: M014
Freskaro Ear Drops for Swimmers	FRESKARO EAR DROPS FOR SWIMMERS	Pharma Nobis, LLC	4f724d85-cd38-41da-e063-6394a90a9fd7	2026-06-03	Warnings	Exact identifier application number: M014
Audiologists Choice Earwax Removal System	CARBAMIDE PEROXIDE	Oaktree Products Inc.	c9ad507b-341c-474f-aaa2-3c3a97a30dd8	2026-05-29	Warnings	Exact identifier application number: M014
CVS Health Earwax Removal Kit	CARBAMIDE PEROXIDE	CVS Pharmacy, Inc.	f842534c-46dd-42c7-8386-9a03ce16da86	2026-05-29	Warnings	Exact identifier application number: M014
Lucid Hearing Earwax Removal Kit and Bulb	CARBAMIDE PEROXIDE	Hearing Lab Technology LLC	5e09f566-397f-44d6-8ba2-90987765c737	2026-05-29	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Amerisource Bergen	89eac1b0-c700-45b5-8478-da53ace72e16	2026-05-29	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal	CARBAMIDE PEROXIDE	Amerisource Bergen	d503b10f-85cd-4bb8-9dec-82d651d525fa	2026-05-29	Warnings	Exact identifier application number: M014
Meijer Earwax Removal Kit	CARBAMIDE PEROXIDE	Meijer Distribution Inc.	a5f7bd55-55c3-4b0e-a16c-33bbea40536a	2026-05-29	Warnings	Exact identifier application number: M014
Quality Choice Earwax Removal Drops	CARBAMIDE PEROXIDE	Chain Drug Marketing Association, Inc.	d8fd8102-114f-415d-9083-f98a63f9d1b3	2026-05-29	Warnings	Exact identifier application number: M014
Menthol Pain Relieving Gel	PAIN RELIEVING GEL	NeilMed Pharmaceuticals Inc	513a206c-bbf6-3e51-e063-6294a90adf7a	2026-05-07	Warnings	Exact identifier application number: M014
ear drops	CARBAMIDE PEROXIDE 6.5%	Bionpharma Inc.	e8bcf92c-ad32-49d5-e053-2995a90ae0c6	2026-04-27	Warnings	Exact identifier application number: M014
Freskaro Earwax Removal Aid	CARBAMIDE PEROXIDE 6.50% KIT	Pharma Nobis, LLC	4f5967ee-bc05-341c-e063-6394a90a35c6	2026-04-15	Warnings	Exact identifier application number: M014
GoodSense Ear Wax Removal Kit	CARBAMIDE PEROXIDE	Preferred Pharmaceuticals Inc.	9a4198d2-cbea-466a-a252-d5c63d9ea0c1	2026-04-09	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Preferred Pharmaceuticals Inc.	52f733a7-1301-4078-9267-5ce95b006ccc	2026-04-09	Warnings	Exact identifier application number: M014
Walgreens Swimmers Ear	ISOPROPYL ALCOHOL	Walgreens Co	3fb65a5c-c47f-ef2b-e063-6394a90af21a	2026-04-01	Warnings	Exact identifier application number: M014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
31PZ2VAU81	CARBAMIDE PEROXIDE	124-43-6	CARBAMIDE PEROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
702050	carbamide peroxide 6.5 % Otic Solution	PSN	ad8bce05-6be4-4f6c-9341-bce7c3aa05cf	7
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	ad8bce05-6be4-4f6c-9341-bce7c3aa05cf	7
702050	carbamide peroxide 6.5 % Otic Solution	SY	ad8bce05-6be4-4f6c-9341-bce7c3aa05cf	7
702050	carbamide peroxide 6.5 % Otic Solution	PSN	eb7df1cc-50db-479a-bc1c-dfd7004dd35b	6
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	eb7df1cc-50db-479a-bc1c-dfd7004dd35b	6
702050	carbamide peroxide 6.5 % Otic Solution	SY	eb7df1cc-50db-479a-bc1c-dfd7004dd35b	6
702050	carbamide peroxide 6.5 % Otic Solution	PSN	d0d69ee3-f073-2666-e053-2a95a90a7206	1
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	d0d69ee3-f073-2666-e053-2a95a90a7206	1
702050	carbamide peroxide 6.5 % Otic Solution	SY	d0d69ee3-f073-2666-e053-2a95a90a7206	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6627-35	00904662735	1 BOTTLE in 1 CARTON (0904-6627-35) / 15 mL in 1 BOTTLE	1 bottle	2019-10-10	2026-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ear Drops Major	Major Pharmaceuticals \| Pharma Nobis, LLC	2025-07-28	HUMAN OTC DRUG LABEL	7
Ear Drops Major	A-S Medication Solutions	2024-01-08	HUMAN OTC DRUG LABEL	6
Ear Drops Major	NuCare Pharmaceuticals,Inc.	2021-11-15	HUMAN OTC DRUG LABEL	1
Ear Drops Major	REMEDYREPACK INC.	2021-01-09	HUMAN OTC DRUG LABEL	4