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 60 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AshleyBelle Moisturizing Hand Sanitizer Lavender Drift	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a2d051-4920-76ee-e063-6294a90a5d3c	2025-10-20	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach Nectar	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	41a36bb3-a648-3b5b-e063-6394a90aa4df	2025-10-20	Warnings	Exact identifier application number: M003
PROHEAL ALCOHOL XXL PREP PADS	ISOPROPYL ALCOHOL	Click Industries LLC	ec81be59-94a5-4675-9047-e3e82d7ad761	2025-10-20	Warnings	Exact identifier application number: M003
ALCOHOL PREP PAD	ISOPROPYL ALCOHOL	Guangdong Comfort Medical Products Co., Ltd.	3a2dea43-8123-3fb7-e063-6294a90a5e50	2025-10-19	Warnings	Exact identifier application number: M003
ANTISEPTIC WIPE	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	3a40a31d-4032-71ba-e063-6294a90a48dc	2025-10-19	Warnings	Exact identifier application number: M003
ANTIBACTERIAL BANDAGES	BENZALKONIUM CHLORIDE	Guangdong Comfort Medical Products Co., Ltd.	6e43b8b3-2d49-8f76-e053-2a91aa0affb0	2025-10-19	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft Berry	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	418fed84-d4ab-7352-e063-6294a90a6dab	2025-10-19	Warnings	Exact identifier application number: M003
BZK CLEANSER	BENZALKONIUM CHLORIDE	Geri-Gentle Corporation	415eb5fb-5f88-d2dd-e063-6394a90abe5d	2025-10-17	Warnings	Exact identifier application number: M003
Medline Alcohol Prep Sterile, Large	ISOPROPYL ALCOHOL	Medline Industries, LP	c9fae7b6-2f4b-490b-9b17-a7297e738069	2025-10-16	Warnings	Exact identifier application number: M003
Medline Alcohol Prep Sterile, Medium	ISOPROPYL ALCOHOL	Medline Industries, LP	9a8584e1-b422-4b77-8464-4e022d578fad	2025-10-16	Warnings	Exact identifier application number: M003
Signature Select Pain Relieving	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	Safeway/Albartsons	3cab1b0c-4ffd-9c01-e063-6294a90ad15d	2025-10-16	Warnings	Exact identifier application number: M003
Medline Alcohol Prep	ISOPROPYL ALCOHOL	Medline Industries, LP	b43c0bff-82f8-c18d-e053-2995a90a8716	2025-10-16	Warnings	Exact identifier application number: M003
Medline	BENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDE	Medline Industries, LP	b1059e68-b240-056c-e053-2995a90a61b2	2025-10-16	Warnings	Exact identifier application number: M003
Meijer Hand Sanitizer Lakeshore Fresh	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	41533b69-05e7-d5f7-e063-6294a90a2d2b	2025-10-16	Warnings	Exact identifier application number: M003
Meijer Hand Sanitizer Pine Forest	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4153ac2a-e51c-f167-e063-6394a90a80d8	2025-10-16	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	412e961a-b7d4-b1c2-e063-6294a90a6b85	2025-10-15	Warnings	Exact identifier application number: M003
equate First Aid Antiseptic	POVIDONE-IODINE	Walmart Inc.	43bbedec-be30-482a-8552-949b13d4bea1	2025-10-14	Warnings	Exact identifier application number: M003
Tridergel	BENZALKONIUM CHLORIDE	Trifluent Pharma LLC	f12d9e8c-1d69-49d9-a9e9-a392c681aa6c	2025-10-13	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Sting Relief Wipe	BENZOCAINE, ALCOHOL	Total Resources International, Inc	5415073f-aa1d-4ed3-aa30-7470cd2efed1	2025-10-10	Warnings	Exact identifier application number: M003
Lemyn Organics Medical-Grade Hand Sanitizer	ALCOHOL	Lemyn LLC	b106289d-346a-74df-e053-2995a90aa426	2025-10-10	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