Merthiolate Tincture

Product NDC: 73635-1224
11-digit product format: 736351224
Labeler code: 73635
Product ID: 73635-1224_5d6da48b-8a65-bfbd-e063-6294a90a2025
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride 0.13%
Dosage form: LIQUID
Route: TOPICAL
Labeler: Germa Products, LLC
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-29
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	73635-1224		D	Discontinued by firm		2026-10-23
excluded package	package	73635-1224	73635-1224-1	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73635-1224-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73635-1224-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73635-1224-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73635-1224-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73635-1224-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73635-1224-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73635-1224-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73635-1224-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73635-1224-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73635-1224-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73635-1224-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73635-1224-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Tincture
Brand name suffix: First Aid Antiseptic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 mg/mL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-05-09	Merthiolate Tincture
2023-05-09	Merthiolate Tincture
2023-05-09	Merthiolate Tincture
2023-01-30	Merthiolate Tincture
2023-01-30	Merthiolate Tincture
2023-01-30	Merthiolate Tincture

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73635-1224-1	Merthiolate TinctureFirst Aid Antiseptic	30 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	30		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73635-1224	MERTHIOLATE TINCTURE FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE 0.13%) LIQUID [GERMA PRODUCTS, LLC]	7	Current NDC, Legacy NDC, 1 package rows	20241017_bf77c2f2-b975-7150-e053-2995a90ae1db.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 93 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Univ of Vermont Medical Center Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7841cfa9-e94e-4c3d-b5fb-676924017845	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital Mothers Vaginal	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7f1a85fd-086b-4fc7-abac-863dd3ea505a	2024-12-17	Warnings	Exact identifier application number: M003
Mary Kay Satin Hands Shea Hand Sanitizer	ALCOHOL	Mary Kay Inc.	b6c2b979-2940-1569-e053-2995a90a532c	2024-12-17	Warnings	Exact identifier application number: M003
Foster and Thrive Decolorized Iodine	ALCOHOL LIQUID	Strategic Sourcing Services, LLC	2981529a-2bd0-3e9e-e063-6294a90a7236	2024-12-17	Warnings	Exact identifier application number: M003
Foster and Thrive 2% Mild Iodine Tincture	IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID	Strategic Sourcing Services, LLC	2981cb97-17de-ebda-e063-6394a90ad281	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital H.E.A.R.T. Strings Tote	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	f8369a27-1995-4fdd-a282-35c344c11d83	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital Amenity Kit	ALCOHOL AND SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	877ce875-c5b0-4d9b-8f00-682914e3bc0e	2024-12-17	Warnings	Exact identifier application number: M003
Wellstar Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	ced9dd96-7922-43d7-906f-32afaad733ec	2024-12-17	Warnings	Exact identifier application number: M003
Northside Hospital C-Section Mothers	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	9df6d0e9-631c-4619-9d96-d2c5a32a590e	2024-12-17	Warnings	Exact identifier application number: M003
Memorial Sloan Kettering Cancer Center Amenity Kit	SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	cab0bef1-f486-4eac-a61b-6030467d8650	2024-12-17	Warnings	Exact identifier application number: M003
Sarasota Memorial Amenity	ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	f5dda019-fcfd-4e99-89cc-e79e76b402e7	2024-12-17	Warnings	Exact identifier application number: M003
Englewood Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	2024-12-17	Warnings	Exact identifier application number: M003
Mentholatum Moisturizing Hand Sanitizer	BENZALKONIUM CHLORIDE	The Mentholatum Company	365c93bc-2299-4e69-ba3a-69414bfe78d7	2024-12-13	Warnings	Exact identifier application number: M003
Curaplex Alcohol Prep Pad	ISOPROPYL ALCOHOL	Sarnova, Inc.	da1a4baa-05eb-4a75-82bb-39c547daef64	2024-12-12	Warnings	Exact identifier application number: M003
Foaming Hand Sanitizer	ALCOHOL	Empack Spraytech Inc.	8bb072f2-9cd4-499d-9d7f-7166451b8f20	2024-12-12	Warnings	Exact identifier application number: M003
Extra Stength Hand Sanitizer Zytec Germ Buster	ALCOHOL 80%W/W	Empack Spraytech Inc.	da854195-3a50-4fae-a5ea-183bf524c973	2024-12-12	Warnings	Exact identifier application number: M003
Zytec Hand Sanitizer Wipes 80% w/w Alcohol	ALCOHOL	Empack Spraytech Inc.	ab86fd0c-40cd-0bb6-e053-2a95a90a76e2	2024-12-12	Warnings	Exact identifier application number: M003
Dermoplast Kids First Aid	BENZETHONIUM CHLORIDE AND BENZOCAINE	Advantice Health, LLC.	29a18018-5214-4080-ac40-e646319e95ce	2024-12-12	Warnings	Exact identifier application number: M003
New Skin Bandage	BENZETHONIUM CHLORIDE	Advantice Health, LLC.	5846f414-8329-4034-b99f-92721bdb3d14	2024-12-12	Warnings	Exact identifier application number: M003
CVS Hand Sanitizer	ALCOHOL	CVS	b5faeb31-67c7-2000-e053-2995a90a1409	2024-12-10	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	bf77c2f2-b975-7150-e053-2995a90ae1db	8
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	bf77c2f2-b975-7150-e053-2995a90ae1db	8
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	bf77c2f2-b975-7150-e053-2995a90ae1db	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73635-1224-1	73635122401	30 mL in 1 BOTTLE, WITH APPLICATOR (73635-1224-1)	30 ml	2021-03-29	0000-00-00	No	No	Current