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
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049254Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
864063a5-c6cc-4657-9cd6-51af4673bf98Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-8010-92HUMCO Merthiolate59 mL in 1 BOTTLELIQUID596

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-8010-92ML - Milliliter0395-8010c913ab30-0840-4b65-912d-379d3f0700ac12015-01-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-8010HUMCO MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [HUMCO HOLDING GROUP, INC.]6Current NDC, Legacy NDC, 1 package rows20231216_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 93 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
application number: M003
Foster and Thrive Decolorized IodineALCOHOL LIQUIDStrategic Sourcing Services, LLC2981529a-2bd0-3e9e-e063-6294a90a72362024-12-17WarningsExact identifier
application number: M003
Foster and Thrive 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDStrategic Sourcing Services, LLC2981cb97-17de-ebda-e063-6394a90ad2812024-12-17WarningsExact identifier
application number: M003
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
application number: M003
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
application number: M003
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
application number: M003
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
application number: M003
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
application number: M003
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
application number: M003
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
application number: M003
Mentholatum Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEThe Mentholatum Company365c93bc-2299-4e69-ba3a-69414bfe78d72024-12-13WarningsExact identifier
application number: M003
Curaplex Alcohol Prep PadISOPROPYL ALCOHOLSarnova, Inc.da1a4baa-05eb-4a75-82bb-39c547daef642024-12-12WarningsExact identifier
application number: M003
Foaming Hand SanitizerALCOHOLEmpack Spraytech Inc.8bb072f2-9cd4-499d-9d7f-7166451b8f202024-12-12WarningsExact identifier
application number: M003
Extra Stength Hand Sanitizer Zytec Germ BusterALCOHOL 80%W/WEmpack Spraytech Inc.da854195-3a50-4fae-a5ea-183bf524c9732024-12-12WarningsExact identifier
application number: M003
Zytec Hand Sanitizer Wipes 80% w/w AlcoholALCOHOLEmpack Spraytech Inc.ab86fd0c-40cd-0bb6-e053-2a95a90a76e22024-12-12WarningsExact identifier
application number: M003
Dermoplast Kids First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLC.29a18018-5214-4080-ac40-e646319e95ce2024-12-12WarningsExact identifier
application number: M003
New Skin BandageBENZETHONIUM CHLORIDEAdvantice Health, LLC.5846f414-8329-4034-b99f-92721bdb3d142024-12-12WarningsExact identifier
application number: M003
CVS Hand SanitizerALCOHOLCVSb5faeb31-67c7-2000-e053-2995a90a14092024-12-10WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC8d1a5c98-8169-4f40-8601-a6f6bbbbebe72024-12-09WarningsExact identifier
application number: M003
NEXXGEN 91% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC12b8c85a-da0c-47a1-9531-c9f2858c4f312024-12-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN864063a5-c6cc-4657-9cd6-51af4673bf986
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD864063a5-c6cc-4657-9cd6-51af4673bf986
1049254benzalkonium chloride 0.13 % Topical SolutionSY864063a5-c6cc-4657-9cd6-51af4673bf986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-8010-920039580109259 mL in 1 BOTTLE (0395-8010-92) 59 ml2017-11-140000-00-00NoNoCurrent