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 95 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OPS RANCH HAND ANTIBACTERIAL FOAMING	CHLOROXYLENOL	Archer Manufacturing, Inc.	d8187090-8423-062e-e053-2a95a90aad18	2024-12-05	Warnings	Exact identifier application number: M003
BLACK OPS AB ANTIBACTERIAL FOAMING	BENZALKONIUM CHLORIDE	Archer Manufacturing, Inc.	d335bf6d-dc75-bd80-e053-2a95a90abb56	2024-12-05	Warnings	Exact identifier application number: M003
OPS INSTANT HAND SANITIZER	BENZALKONIUM CHLORIDE	Archer Manufacturing, Inc.	d4c65a93-832a-6a8b-e053-2a95a90a77b8	2024-12-05	Warnings	Exact identifier application number: M003
alcohol pad 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	03a6e8d4-535d-b316-e063-6294a90aebf5	2024-12-04	Warnings	Exact identifier application number: M003
antiseptic towelette 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f2a1f1-ceb6-2f20-e053-2a95a90a18db	2024-12-04	Warnings	Exact identifier application number: M003
BobBarker antibacterial wrapped body	BENZETHONIUM CHLORIDE	Yangzhou H&R Plastic Daily Chemical Co., Ltd.	208b37b4-cfc3-4bf1-adc1-96d4b1d2cfa5	2024-12-04	Warnings	Exact identifier application number: M003
Walgreens 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walgreen Co.	21f125a0-73e8-34a9-e063-6294a90a8396	2024-12-04	Warnings	Exact identifier application number: M003
Emory Johns Creek Amenity	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global	952ccb85-71bb-4d5d-ac9b-62851a39d36d	2024-12-04	Warnings	Exact identifier application number: M003
Watermelon Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1f0f9885-2ad5-09de-e063-6394a90ad0d7	2024-12-03	Warnings	Exact identifier application number: M003
Foster and Thrive Povidone-Iodine	POVIDONE IODINE	Strategic Sourcing Services, LLC	28621f29-ce45-c6dc-e063-6294a90aa5f7	2024-12-03	Warnings	Exact identifier application number: M003
Sanitizing Hand Mist Unscented	ETHYL ALCOHOL	ALO New York LLC	e194daee-2197-4718-e053-2a95a90a4890	2024-12-03	Warnings	Exact identifier application number: M003
Instant Hand Antiseptic	ALCOHOL	ASP Global	291eaa18-81f8-6907-e054-00144ff88e88	2024-12-03	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Passion Berrys	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	aee5d7c2-93b3-f55e-e053-2995a90af72e	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Fresh and Relax	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d3086-7902-2837-e053-2995a90a39df	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Grapefruit	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f49-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Red Fruits	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f4d-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Oatmeal	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e1c5f6-195c-16d6-e063-6394a90abb86	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Instant Hand Sanitizer	ETHYL ALCOHOL 70%	Industria La Popular, S.A.	b2e4d58d-adff-3cb2-e053-2995a90a392e	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2289d-60f4-260c-e063-6394a90a96f6	2024-12-02	Warnings	Exact identifier application number: M003
Jabonito Kids Green Apple Liquid	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	021bc525-3ebe-efc2-e063-6394a90a3fe3	2024-12-02	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