Ear Wax Removal Drops

Product NDC: 57896-339
11-digit product format: 578960339
Labeler code: 57896
Product ID: 57896-339_4589c7e6-c807-5a69-e063-6394a90a8b89
Type: HUMAN OTC DRUG
Nonproprietary name: Carbamide Peroxide - 6.5%
Dosage form: SOLUTION/ DROPS
Route: TOPICAL
Labeler: GeriCare Pharmaceutical Corp
Application: M014
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-09-01
Substance: CARBAMIDE PEROXIDE
Active strength: 65 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57896-339-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57896-339-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57896-339-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57896-339-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57896-339-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57896-339-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57896-339-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57896-339-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57896-339-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57896-339-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57896-339-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57896-339-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ear Wax Removal Drops
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMIDE PEROXIDE	65 mg/mL

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
239702af-cf93-43ee-b1af-8e53642395c1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57896-339-05	Ear Wax Removal Drops	1 in 1 CARTON	SOLUTION/ DROPS	1		3
57896-339-05	Ear Wax Removal Drops	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-339-05	ML - Milliliter	57896-339	60f9d315-f236-4cbe-ba42-4d7e2bd5bcca	1	2018-01-12

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EAR WAX RMVL Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	9e3cedcc-e523-2653-e053-2a95a90ad143	2023-12-15	Warnings	Exact identifier application number: M014
EarWax Removal Kit Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	da78ac58-6c1c-4fa9-baac-e9dec0241385	2023-12-15	Warnings	Exact identifier application number: M014
Otix Ear wax Removal System Ear wax and Bulb	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	15868798-28cd-4495-9baf-711e81ad8bdd	2023-12-14	Warnings	Exact identifier application number: M014
Otix Ear wax Removal Drops	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	0e70ab09-9360-4ab6-a1fe-6f82af392581	2023-12-14	Warnings	Exact identifier application number: M014
TopCare Earwax Removal Drops	CARBAMIDE PEROXIDE	Topco Associates LLC	c5b1ad0e-3712-40fd-afbe-54c0b5f1160b	2023-12-14	Warnings	Exact identifier application number: M014
DG Health Earwax Removal kit	CARBAMIDE PEROXIDE 6.5%	DOLLAR GENERAL CORPORATION	4b6fc00f-72d7-4675-9881-b763f27c06e3	2023-12-07	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops Equate	CARBAMIDE PEROXIDE - 6.5%	WALMART STORES INC	33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d	2023-12-04	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Proficient Rx LP	a131447b-a5a0-45cd-a59c-a9f719275baa	2023-12-01	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops	CARBAMIDE PEROXIDE - 6.5%	Sheffield Pharmaceuticals LLC	aad7e2cd-cb28-423c-a441-eabe6516d40f	2022-12-06	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	239702af-cf93-43ee-b1af-8e53642395c1	3
702050	carbamide peroxide 6.5 % Otic Solution	PSN	97f81751-5a8f-4943-9e37-091351867598	3
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	239702af-cf93-43ee-b1af-8e53642395c1	3
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	97f81751-5a8f-4943-9e37-091351867598	3
702050	carbamide peroxide 6.5 % Otic Solution	SY	239702af-cf93-43ee-b1af-8e53642395c1	3
702050	carbamide peroxide 6.5 % Otic Solution	SY	97f81751-5a8f-4943-9e37-091351867598	3
702050	carbamide peroxide 6.5 % Otic Solution	PSN	b6e3ad1c-5134-49f2-8664-534635b9eec3	1
702050	carbamide peroxide 65 MG/ML Otic Solution	SCD	b6e3ad1c-5134-49f2-8664-534635b9eec3	1
702050	carbamide peroxide 6.5 % Otic Solution	SY	b6e3ad1c-5134-49f2-8664-534635b9eec3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-339-05	57896033905	1 BOTTLE, DROPPER in 1 CARTON (57896-339-05) / 15 mL in 1 BOTTLE, DROPPER	2025-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	GeriCare Pharmaceutical Corp	2025-12-09	HUMAN OTC DRUG LABEL	3
Drug Facts	NuCare Pharmaceuticals,Inc.	2021-01-11	HUMAN OTC DRUG LABEL	4
Drug Facts	Preferred Pharmaceuticals, Inc.	2020-03-02	HUMAN OTC DRUG LABEL	1
Drug Facts	A-S Medication Solutions	2020-01-18	HUMAN OTC DRUG LABEL	3
Drug Facts	REMEDYREPACK INC.	2019-03-11	HUMAN OTC DRUG LABEL	3