HUMCO Merthiolate

Product NDC: 0395-8010
11-digit product format: 003958010
Labeler code: 0395
Product ID: 0395-8010_0c9364b5-e361-068e-e063-6394a90a3386
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Humco Holding Group, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1998-03-25
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
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: HUMCO Merthiolate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 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
1049254	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
864063a5-c6cc-4657-9cd6-51af4673bf98	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-8010-92	HUMCO Merthiolate	59 mL in 1 BOTTLE	LIQUID	59		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-8010-92	ML - Milliliter	0395-8010	c913ab30-0840-4b65-912d-379d3f0700ac	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC]	1
ACETONE	INACTIVE INGREDIENT	1364PS73AF	HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-8010	HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20231216_864063a5-c6cc-4657-9cd6-51af4673bf98.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 59 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
American Red Cross Antiseptic	BENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41bbf123-9ff9-5e8a-e063-6394a90af15f	2025-10-22	Warnings	Exact identifier application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CARE	BENZETHONIUM CHLORIDE	FNC MEDICAL CORPORATION	f93c55f9-b3e1-45f6-8e0d-09e60f5b822f	2025-10-22	Warnings	Exact identifier application number: M003
CA-REZZ - NORISC - INCONTINENT WASH	BENZETHONIUM CHLORIDE	FNC MEDICAL CORPORATION	ed26fa74-5ae8-4294-b61d-682d6ad4b32a	2025-10-22	Warnings	Exact identifier application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSER	BENZETHONIUM CHLORIDE	FNC MEDICAL CORPORATION	d06b0489-86d3-4bf1-928f-fc524a71560e	2025-10-22	Warnings	Exact identifier application number: M003
Northside Hospital Maternity Backpack-BASE	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	86458169-92eb-45a5-b3cc-6eccd8caa1e8	2025-10-22	Warnings	Exact identifier application number: M003
Northside Hospital Maternity Backpack BASE	SODIUM MONOFLUOROPHOSPATE	ALLIANCE FORMULATIONS	5d0e768f-086c-4b8c-b618-6dde70f302f9	2025-10-22	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea Breeze	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a5db85-05b8-ecd6-e063-6394a90ac387	2025-10-21	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a62d9f-4d46-f8ca-e063-6294a90ae1ed	2025-10-21	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla Cloud	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a69d10-f7bf-cf17-e063-6294a90a177d	2025-10-21	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon Aloe	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a7735f-03b7-4fdc-e063-6394a90a100b	2025-10-21	Warnings	Exact identifier application number: M003
American Red Cross 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL(70%CONC.)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41b6ee3f-55f4-0502-e063-6394a90aa357	2025-10-21	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Tangy Terrane	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4192dbc6-5d9a-d42a-e063-6394a90aa2d8	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Sweet and Still	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41934870-d87e-1c51-e063-6294a90abd2d	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Cashmere Char	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41938c11-391c-0a55-e063-6394a90ad451	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Tea and Timber	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4193d08a-bc54-ef3b-e063-6294a90a0608	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41940273-689d-0f44-e063-6294a90a957f	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Vanilla Verdant	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41942841-faa9-114e-e063-6294a90a0e58	2025-10-20	Warnings	Exact identifier application number: M003
Smart Care Luxury Hand Sanitizer Zen and Zest	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	419441a8-a6df-e15d-e063-6294a90a02ae	2025-10-20	Warnings	Exact identifier application number: M003
CVS Alcohol Prep	ISOPROPYL ALCOHOL	CVS Pharmacy	7abc66f2-faf6-421c-9c3c-b69f5a587246	2025-10-20	Warnings	Exact identifier application number: M003
Gentian Violet	GENTIAN VIOLET	World Perfumes Inc	419cc9a2-bfde-a516-e063-6294a90a065c	2025-10-20	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
1049254	benzalkonium chloride 0.13 % Topical Solution	PSN	864063a5-c6cc-4657-9cd6-51af4673bf98	6
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	864063a5-c6cc-4657-9cd6-51af4673bf98	6
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	864063a5-c6cc-4657-9cd6-51af4673bf98	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0395-8010-92	00395801092	59 mL in 1 BOTTLE (0395-8010-92)	59 ml	2017-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HUMCO Merthiolate	Humco Holding Group, Inc. \| Pharma Nobis, LLC	2023-12-15	HUMAN OTC DRUG LABEL	6