Hygienic Ear Care Antiseptic

Product NDC: 70094-001
11-digit product format: 700940001
Labeler code: 70094
Product ID: 70094-001_098688fd-eb21-29d6-e063-6294a90ade41
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: The Richline Group, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-01
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.2 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Hygienic Ear Care Antiseptic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052949	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
98b70f22-cd53-e61b-e053-2995a90a730d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70094-001-04	Hygienic Ear Care Antiseptic	118 mL in 1 BOTTLE	SOLUTION	118		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70094-001	HYGIENIC EAR CARE ANTISEPTIC (BENZALKONIUM CHLORIDE) SOLUTION [THE RICHLINE GROUP, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20231108_98b70f22-cd53-e61b-e053-2995a90a730d.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 97 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maokang 10 Povidone Iodine	POVIDONE-IODINE	Changzhou Maokang Medical Products Co., Ltd	7c17ce40-0358-44ff-aa60-53711666914b	2024-11-21	Warnings	Exact identifier application number: M003
MK Alcohol Prep Pads Medium	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	11390854-9e72-40a2-9c89-3c29a585dced	2024-11-21	Warnings	Exact identifier application number: M003
Instant Hand Sanitizeing Wipe	ISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTS	Shandong Yayun Sanitary Products Co., Ltd.	aa0dc01a-2c6b-7402-e053-2a95a90af6a2	2024-11-21	Warnings	Exact identifier application number: M003
Dynarex Povidone Iodine Prep Solution	POVIDONE IODINE PREP SOLUTION	Dynarex Corporation	6bb4d55b-2be7-3549-e053-2a91aa0a2bb0	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Povidone Iodine Surgical Scrub	POVIDONE IODINE SURGICAL SCRUB SOLUTION	Dynarex Corporation	6f053e55-cbf6-9072-e053-2991aa0a2edd	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	ALCOHOL	Dynarex Corporation	072572be-49dd-4594-bc40-b56db57ada5b	2024-11-20	Warnings	Exact identifier application number: M003
Dynarex Green	CHLOROXYLENOL	Dynarex Corporation	59b098d2-08de-4fdb-a209-ae226abf37d6	2024-11-20	Warnings	Exact identifier application number: M003
Baby Wipes	PROPYLENE GLYCOL	Shandong Yayun Sanitary Products Co., Ltd.	aeb9a12c-955f-5030-e053-2995a90a2dd6	2024-11-20	Warnings	Exact identifier application number: M003
Pet wipes	BENZALKONIUM CHLORIDE	Shandong Yayun Sanitary Products Co., Ltd.	2764ea79-32d8-b7f6-e063-6394a90a5501	2024-11-20	Warnings	Exact identifier application number: M003
Premium Hand Sanitizer	ETHANOL	MCKESSON MEDICAL-SURGICAL INC.	a9514466-e0c6-4792-984a-9f07d94ee887	2024-11-18	Warnings	Exact identifier application number: M003
MARVEL BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	93ed0bb4-834d-44ca-9c0a-20086fc09ab8	2024-11-18	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	McKesson Medical-Surgical Inc.	98b0bcc2-539b-4471-ba98-bbe17bb881bd	2024-11-15	Warnings	Exact identifier application number: M003
CVS Health Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	CVS PHARMACY, INC	7a930a5e-5b69-428f-9cbb-d03dae180295	2024-11-12	Warnings	Exact identifier application number: M003
First Aid Only Povidone-Iodine Prep Pad	POVIDONE-IODINE	Acme United Corporation	509b6c8e-6a9f-2656-e054-00144ff8d46c	2024-11-09	Warnings	Exact identifier application number: M003
MED NAP Cleansing Towelette	BENZALKONIUM CHLORIDE	Acme United Corporation	d92cd45a-234c-4872-e053-2a95a90a3e1c	2024-11-09	Warnings	Exact identifier application number: M003
MED NAP Obstetrical Towelette	BENZALKONIUM CHLORIDE	Acme United Corporation	d83d2fab-6972-9b18-e053-2995a90a5cb5	2024-11-09	Warnings	Exact identifier application number: M003
MED NAP Benzalkonium Chloride Antiseptic	BENZALKONIUM CHLORIDE	Acme United Corporation	d7c404c1-c765-a67c-e053-2995a90a6b8e	2024-11-09	Warnings	Exact identifier application number: M003
Barbie BZK ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Ashtel Studios, Inc.	d675eb91-80a8-4874-a2b0-c2bf69264911	2024-11-08	Warnings	Exact identifier application number: M003
Barbie ALCOHOL WIPE	ISOPROPYL ALCOHOL	Ashtel Studios, Inc.	a4a6beb0-5781-4d74-9120-7ca64e035c23	2024-11-08	Warnings	Exact identifier application number: M003
MARVEL ALCOHOL WIPE	ISOPROPYL ALCOHOL	Ashtel Studios, Inc.	f6cd4757-d6e0-46bd-827f-3f380c71858f	2024-11-07	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052949	benzalkonium chloride 0.12 % Topical Solution	PSN	98b70f22-cd53-e61b-e053-2995a90a730d	3
1052949	benzalkonium chloride 1.2 MG/ML Topical Solution	SCD	98b70f22-cd53-e61b-e053-2995a90a730d	3
1052949	benzalkonium chloride 0.12 % Topical Solution	SY	98b70f22-cd53-e61b-e053-2995a90a730d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70094-001-04	70094000104	118 mL in 1 BOTTLE (70094-001-04)	118 ml	2020-01-01	0000-00-00	No	No	Current