FDA.reportPublic FDA data

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 84 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLWalgreens78ed5594-433a-4f90-ad39-51e2a7dd2e212025-02-21WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLWalgreens9effa6c9-020d-4a2d-ad26-449d4119b6a02025-02-21WarningsExact identifier
application number: M003
Isopropyl alcohol 50 percent Wintergreen ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCf9ff67b0-c4ad-4162-b3ef-27a85ed0da252025-02-18WarningsExact identifier
application number: M003
Inverness Home Ear Piercing KitBENZALKONIUM CHLORIDEThe Richline Group, Inc.80909a34-21da-4c54-bb62-fd986fd24b042025-02-17WarningsExact identifier
application number: M003
Inverness EAR CARE ANTISEPTICBENZALKONIUM CHLORIDEThe Richline Groupac42d2f1-69e3-45f6-8002-d45ebed5ee222025-02-17WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1507f1-a88f-4ef8-e063-6294a90a92fd2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e159f8f-352c-45ca-e063-6394a90adf9b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e1633f1-4b59-6eea-e063-6294a90ae61b2025-02-14WarningsExact identifier
application number: M003
Licensed Hand Sanitizer Spider man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2e16c9bc-223d-0c65-e063-6294a90a48152025-02-14WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.3007da5f-e2ea-4f3a-905c-770782da014e2025-02-14WarningsExact identifier
application number: M003
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Lemon IceETHYL ALCOHOLNingbo Rejoice Internationala266624f-2175-2fd4-e053-2995a90a33052025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.ETHYL ALCOHOLNingbo Rejoice Internationala2677a83-8f9a-7470-e053-2a95a90aa2892025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala2695f96-ef8c-bba6-e053-2a95a90a243e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 1.8 ozETHYL ALCOHOLNingbo Rejoice Internationala26a866a-bb5f-4b5f-e053-2995a90a97452025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala269e72d-c74b-71ed-e053-2995a90ac1472025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala269a222-95cb-098c-e053-2995a90a21e72025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala346ebd2-fc31-b574-e053-2995a90a0d3a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala7364361-f8ad-fc71-e053-2995a90a68a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala73698ca-2097-3f7d-e053-2a95a90a638a2025-02-13WarningsExact 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