Debrox Swimmers Ear

Product NDC: 63029-323
11-digit product format: 630290323
Labeler code: 63029
Product ID: 63029-323_26ccea52-4ce6-4e95-b838-4824523e579c
Type: HUMAN OTC DRUG
Nonproprietary name: isopropyl alcohol
Dosage form: LIQUID
Route: AURICULAR (OTIC)
Labeler: Medtech Products Inc.
Application: M014
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-01
Substance: ISOPROPYL ALCOHOL
Active strength: 95 mL/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Debrox Swimmers Ear
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOPROPYL ALCOHOL	95 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ND2M416302	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
631799	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
b5d57c7b-8315-4260-967e-38fdd54e2a9c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63029-323-01	Debrox Swimmers Ear	30 mL in 1 BOTTLE	LIQUID	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-323	DEBROX SWIMMERS EAR (ISOPROPYL ALCOHOL) LIQUID [MEDTECH PRODUCTS INC.]	2	Current NDC, Legacy NDC, 1 package rows	20241210_b5d57c7b-8315-4260-967e-38fdd54e2a9c.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 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
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
631799	isopropyl alcohol 95 % Otic Solution	PSN	b5d57c7b-8315-4260-967e-38fdd54e2a9c	3
631799	isopropyl alcohol 0.95 ML/ML Otic Solution	SCD	b5d57c7b-8315-4260-967e-38fdd54e2a9c	3
631799	isopropyl alcohol 94.998 % Otic Solution	SY	b5d57c7b-8315-4260-967e-38fdd54e2a9c	3
631799	isopropyl alcohol 95 % Otic Solution	SY	b5d57c7b-8315-4260-967e-38fdd54e2a9c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63029-323-01	63029032301	30 mL in 1 BOTTLE (63029-323-01)	30 ml	2019-04-01	0000-00-00	No	No	Current