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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct73635-1224DDiscontinued by firm2026-10-15
excluded packagepackage73635-122473635-1224-1DDiscontinued by firm2026-10-15

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage73635-1224-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage73635-1224-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage73635-1224-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage73635-1224-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage73635-1224-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage73635-1224-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage73635-1224-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage73635-1224-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73635-1224-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage73635-1224-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage73635-1224-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage73635-1224-1557ba5c1ecfa…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
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73635-1224-1Merthiolate TinctureFirst Aid Antiseptic30 mL in 1 BOTTLE, WITH APPLICATORLIQUID308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73635-1224MERTHIOLATE TINCTURE FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE 0.13%) LIQUID [GERMA PRODUCTS, LLC]7Current NDC, Legacy NDC, 1 package rows20241017_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 6 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd4b642dfa-f044-4410-81e4-142f0497f0f32026-08-06WarningsExact identifier
application number: M003
antibacterial wipes 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.585dec39-ccb8-d2ba-e063-6394a90aec0f2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
application number: M003
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLC57c496b3-10ab-4a72-8d8f-42a2256189dd2026-08-06WarningsExact identifier
application number: M003
PROHEAL ALCOHOL PREP PADSISOPROPYL ALCOHOLClick Industries LLCd272c1f6-e9c9-4099-9d24-f5aae44082ae2026-08-05WarningsExact identifier
application number: M003
Wish Sanitizing Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.c81c0924-bb01-4fa2-b933-8777358e45e72026-08-05WarningsExact identifier
application number: M003
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOMALCOHOLShenzhen Lantern Scicence Co.,Ltd.5833c261-021a-2db2-e063-6394a90a22b02026-08-04WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Soft PetalsALCOHOLShenzhen Lantern Scicence Co.,Ltd.583438a6-c06c-87f5-e063-6394a90adec12026-08-04WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Hibiscus and AloeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5834801e-20e5-bffb-e063-6394a90a03592026-08-04WarningsExact identifier
application number: M003
Medi-First Antiseptic WipesBENZALKONIUM CHLORIDEUnifirst First Aid Corporationd31fe110-6d75-bf15-e053-2a95a90a86942026-08-03WarningsExact identifier
application number: M003
First ShieldHYDROGEN PEROXIDEEVER READY FIRST AID94307d2f-5366-4fdb-b919-4a8658dda0582026-08-03WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Passion Fruit SplashALCOHOLShenzhen Lantern Scicence Co.,Ltd.583159a9-331a-b53b-e063-6294a90a41a32026-08-03WarningsExact identifier
application number: M003
BBlove Hand Sanitizer Fresh Squeezed SpearmintALCOHOLShenzhen Lantern Scicence Co.,Ltd.581b4b8d-fe65-f297-e063-6394a90a5a432026-08-02WarningsExact identifier
application number: M003
Mistify Hand Sanitizer Cotton Candy and Gummy BearALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987e492-b3b6-ed57-e063-6394a90a223a2026-08-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNbf77c2f2-b975-7150-e053-2995a90ae1db8
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDbf77c2f2-b975-7150-e053-2995a90ae1db8
1049254benzalkonium chloride 0.13 % Topical SolutionSYbf77c2f2-b975-7150-e053-2995a90ae1db8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73635-1224-17363512240130 mL in 1 BOTTLE, WITH APPLICATOR (73635-1224-1) 30 ml2021-03-290000-00-00NoNoCurrent