FDA.reportPublic FDA data

Wintergreen 91 - Iron Lab

Product NDC
74375-010
11-digit product format
743750010
Labeler code
74375
Product ID
74375-010_4b08b912-921b-cac4-e063-6394a90a2626
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Iron Lab SA de CV
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-07
Substance
ALCOHOL
Active strength
91 mL/100mL
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
Wintergreen 91 - Iron Lab
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL91 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2710539Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
323a0717-0d61-c911-e063-6394a90a4854Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74375-010-01Wintergreen 91 - Iron Lab355 mL in 1 BOTTLE, PUMPLIQUID3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74375-010WINTERGREEN 91 - IRON LAB (ETHYL ALCOHOL) LIQUID [IRON LAB SA DE CV]1Current NDC, 1 package rows20250409_323a0717-0d61-c911-e063-6394a90a4854.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 49 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b39e9-cf8e-3268-e063-6394a90a69c02025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462a1437-154c-0324-e063-6294a90a12662025-12-17WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLFamily Dollar Stores, Inc.15af30ec-f77d-2f5c-e063-6394a90a05802025-12-17WarningsExact identifier
application number: M003
Signature Select Isopropyl Alcohol Wipes (40 count)ISOPROPYL ALCOHOLBetter Living Brands LLCc9efcad4-f85c-4b10-9984-55549a4ff0262025-12-17WarningsExact identifier
application number: M003
finipil 4 men onlyBENZETHONIUM CHLORIDEEquibal, Inc.aba2e3e6-6047-416d-8ca3-44f1033671e32025-12-17WarningsExact identifier
application number: M003
finipil pro/elecBENZETHONIUM CHLORIDEEquibal, Inc.f68aa5db-7a4e-410f-8159-3356d9407d312025-12-17WarningsExact identifier
application number: M003
Made for MenBENZETHONIUM CHLORIDEEquibal, Inc.d12f748d-7dc5-4cd7-9718-ebb47171d58b2025-12-17WarningsExact identifier
application number: M003
QuickMendBENZETHONIUM CHLORIDEEquibal, Inc.9b0c85a4-9727-4940-a934-0b81a7c938cf2025-12-17WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2710539ethanol 91 % Topical SolutionPSN323a0717-0d61-c911-e063-6394a90a48542
2710539ethanol 0.91 ML/ML Topical SolutionSCD323a0717-0d61-c911-e063-6394a90a48542
2710539ethanol 91 % Topical SolutionSY323a0717-0d61-c911-e063-6394a90a48542
2710539ethyl alcohol 91 % Topical SolutionSY323a0717-0d61-c911-e063-6394a90a48542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74375-010-0174375001001355 mL in 1 BOTTLE, PUMP (74375-010-01) 355 ml2025-04-07NoNoCurrent