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
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
e42f727c-beaf-fe9d-e053-2995a90aafeaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-912-92Merthiolate59 mL in 1 BOTTLELIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-912MERTHIOLATE (BENZALKONIUM CHLORIDE) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_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 71 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f8420-9673-6f77-e063-6294a90a81e42025-08-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3af609-d342-449a-e063-6294a90a0a192025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3bd802-56de-ebcd-e063-6294a90aca152025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild RoseALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3c78f6-e6cb-e456-e063-6394a90ac5b82025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c4bceac-21bc-486e-e063-6394a90a0f372025-08-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c25e093-0335-fa1d-e063-6394a90ae6842025-08-12WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c266de8-0551-374c-e063-6394a90ab9f42025-08-12WarningsExact identifier
application number: M003
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEHAIAN KANGRUI TEXTILE CO., LTD.3c273544-4562-8f37-e063-6394a90ab4d32025-08-12WarningsExact identifier
application number: M003
HealthWise Lidocaine CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEVeridian Healthcare6022803a-097e-41c6-b9ee-48c8ef380d7a2025-08-12WarningsExact identifier
application number: M003
Hand Sanitizer WipesISOPROPYL ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c37f72b-623c-c8f6-e063-6294a90a971e2025-08-12WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c236c0b-fccd-6992-e063-6294a90a37ce2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c2322e0-90d5-6ce6-e063-6394a90ac8bb2025-08-11WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c23d45e-9050-5b9e-e063-6294a90abd4a2025-08-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafetec of America, Inc.89310a64-c4cc-46c6-8294-c4d28cd881182025-08-08WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Citrus SunshineETHYL ALCOHOLWhole Foods Market, Inc.3bcf1071-2308-b989-e063-6294a90a68232025-08-07WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDELJ Pharmae468ad76-b26a-49f0-a2c5-a027299babc72025-08-05WarningsExact identifier
application number: M003
Armor Antibacterial Body Treatment Benzalkonium ChlorideBENZALKONIUM CHLORIDERida LLC95761213-bf90-4ba6-a17b-7470a0f316232025-08-05WarningsExact identifier
application number: M003
AerowipeANSTISEPTIC WIPEAero Healthcare34ca12c7-9281-263c-e054-00144ff8d46c2025-08-01WarningsExact identifier
application number: M003
KeriCleanz ANTISEPTICHYDROGEN PEROXIDEKericure Inc.79b0d9bb-0fa5-4e45-ab74-9ff0e12152382025-07-31WarningsExact identifier
application number: M003
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNe42f727c-beaf-fe9d-e053-2995a90aafea2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDe42f727c-beaf-fe9d-e053-2995a90aafea2
1049254benzalkonium chloride 0.13 % Topical SolutionSYe42f727c-beaf-fe9d-e053-2995a90aafea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-912-928264509129259 mL in 1 BOTTLE (82645-912-92) 59 ml2017-11-140000-00-00NoNoCurrent