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 68 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	7560c80b-8952-4748-af3a-20e3d4255695	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Derma-Caine Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	Unifirst First Aid Corporation	67629392-7e02-321a-e053-2991aa0a0f24	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	b3ef1ef5-1f6f-874a-e053-2995a90a32b1	2025-09-08	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	a0f58025-2c50-45dc-94db-cacbd4cf604c	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Alcohol Wipes	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	ce6992d8-037f-61c7-e053-2a95a90ad0b0	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antimicrobial Towelettes	ETHYL ALCOHOL 66.5%	Unifirst First Aid Corporation	6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c5	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	b4627f3f-6282-51bf-e053-2a95a90a3d59	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	b463d09c-4b33-3774-e053-2a95a90a046b	2025-09-08	Warnings	Exact identifier application number: M003
Thompson Burn Cream with Lidocain	BENZALKONIUM CHLORIDE, LIDOCAINE	Thompson Safety	11729e6b-b911-5c1f-e063-6394a90a0c34	2025-09-08	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ALCOHOL GEL	Thompson	06beaf35-f814-bf9b-e063-6294a90aec8c	2025-09-08	Warnings	Exact identifier application number: M003
Smart Care Kids Hand Sanitizer Barbie	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e41580a-64c5-480f-e063-6294a90a4bf1	2025-09-07	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2869cb20-9cd4-54f5-e063-6294a90a5fea	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	28694168-3362-de4f-e063-6394a90a2e35	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Cucumber Melon Hand Sanitizer	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e0a5382-7b58-fd6e-e063-6394a90abf66	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e09c0aa-0241-0816-e063-6294a90a481e	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3080d8a2-a780-e79b-e063-6294a90ac654	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3081e1b5-66b4-77a8-e063-6394a90a8dd3	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	30847dd5-e378-1a35-e063-6294a90a43da	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3084d980-29ca-91ca-e063-6294a90a6c67	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 3pk 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3099e6af-8072-d26b-e063-6394a90a39ef	2025-09-05	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