Merthiolate

Product NDC: 82645-912
11-digit product format: 826450912
Labeler code: 82645
Product ID: 82645-912_0d1cf782-d2a5-7dee-e063-6294a90a3604
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pharma Nobis, LLC
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: 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
e42f727c-beaf-fe9d-e053-2995a90aafea	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82645-912-92	Merthiolate	59 mL in 1 BOTTLE	LIQUID	59		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82645-912	MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMA NOBIS, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20231223_e42f727c-beaf-fe9d-e053-2995a90aafea.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 105 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Novex Hand Sanitizer	BENZALKONIUM CHLORIDE	Natural Essentials, Inc.	8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3	2024-03-20	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE 0.13%	Trifecta Pharmaceuticals USA, LLC.	13f1c70f-3b44-8eef-e063-6294a90af634	2024-03-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	1308ce91-2858-310a-e063-6394a90a6810	2024-03-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Cocoa Butter	ETHYL ALCOHOL	Rejoice International, Inc.	97dee45e-53be-4b37-a427-fc24388c0e05	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer Aloe Vera	ETHYL ALCOHOL	Rejoice International, Inc.	1e28454c-f5d8-4d6e-91f9-bc4501b027c1	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Clear	ETHYL ALCOHOL	Rejoice International, Inc.	f0e637d9-d61e-466d-9e05-f906639dbaca	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International, Inc.	07b163e4-8f67-44e7-b5ef-f237023080e0	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Ice Clear	ETHYL ALCOHOL	Rejoice International, Inc.	605ec88a-2f4c-4716-8522-eb2748b43398	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Original	ETHYL ALCOHOL	Rejoice International, Inc.	bb9cc886-275e-4996-99dc-529f928b4905	2024-02-28	Warnings	Exact identifier application number: M003
Liquid Hand Cleanse	TRICLOSAN	Rejoice International, Inc.	23ff5450-8308-41c0-9052-1ac4c4433d6c	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Original	TRICLOSAN	Rejoice International, Inc.	b5ce6663-fe82-4da1-923e-acea293d7a00	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate	TRICLOSAN	Rejoice International, Inc.	b68a7d64-2650-4fc6-a89e-05de9098a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Mountain Spring	TRICLOSAN	Rejoice International, Inc.	c31723d5-a313-448a-8b69-ca5f8dec25ed	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	a9a1467c-abcc-4ccb-88f6-430279609788	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	9fa9d955-7167-4a0a-935b-2a600f439eb0	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Rejoice International	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	45b3ca49-edb4-4840-b857-d24045494a3a	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	4890f81e-7994-4ea2-9412-5614c405a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	5c109f7c-1f4d-484a-b6ea-3bbcf572bbac	2024-02-28	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	e42f727c-beaf-fe9d-e053-2995a90aafea	2
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	e42f727c-beaf-fe9d-e053-2995a90aafea	2
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	e42f727c-beaf-fe9d-e053-2995a90aafea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82645-912-92	82645091292	59 mL in 1 BOTTLE (82645-912-92)	59 ml	2017-11-14	0000-00-00	No	No	Current