FDA.reportPublic FDA data

AWAS ALCOHOLSPRAY

Product NDC
77039-024
11-digit product format
770390024
Labeler code
77039
Product ID
77039-024_2cf6b8fa-ee81-3e75-e063-6294a90a7350
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
IDO PHARM
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-16
Substance
ALCOHOL
Active strength
83 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage77039-024-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage77039-024-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage77039-024-010efc9e666f02…f202fb6c5f17…

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
AWAS ALCOHOLSPRAY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL83 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
2288438Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03010837-0289-3e08-e063-6394a90a7d04Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77039-024-012025-02-03C16284748780-12cef2736-92ac-d83d-e063-dadaa90ab31f03010837-0289-3e08-e063-6394a90a7d04
77039-024-012025-01-30C16284748780-12cef2736-92ac-d83d-e063-dadaa90ab31f03010837-0289-3e08-e063-6394a90a7d04

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77039-024-01AWAS ALCOHOLSPRAY500 mL in 1 BOTTLE, SPRAYSPRAY5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77039-024AWAS ALCOHOLSPRAY (ALCOHOL) SPRAY [IDO PHARM]2Current NDC, 1 package rows20250205_03010837-0289-3e08-e063-6394a90a7d04.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 25 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal LiquidTOLNAFTATELEADER/ Cardinal Health 110, Inc.441f88df-6417-d7db-e063-6394a90a14022025-12-31WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAY - TALC FREELEADER/ Cardinal Health 110, Inc.a9fdd129-9909-4747-bd9f-93a204b507242025-12-31WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREECardinal Healthd90b210b-ade5-4b41-ad34-87f779cbb8ad2025-12-31WarningsExact identifier
application number: M005
Antifungal PowderMICONAZOLE NITRATELEADER/ Cardinal Health 110, Inc.1fcf072b-cf12-967a-e063-6294a90acfc72025-12-31WarningsExact identifier
application number: M005
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
application number: M005
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
application number: M005
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
application number: M005
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
application number: M005
CuraNails Antifungal PenUNDECYLENIC ACID 25%Quality Discount Inc.3e641d36-72f6-4682-bd31-f7cd04d857f22025-12-25WarningsExact identifier
application number: M005
Opti-Nail 2-in-1TOLNAFTATEKramer Laboratoriesbc8a5492-8bd0-4c80-a270-e4958aeb5ed62025-12-23WarningsExact identifier
application number: M005
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
application number: M005
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
application number: M005
TopCare Antifungal Maximum StrengthUNDECYLENIC ACIDTOPCO ASSOCIATES LLC7c44fb4e-0eef-4ced-b03f-a02ebe6c02642025-12-22WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
application number: M005
HC Max Anti-FungalTOLNAFTATEKramer Laboratoriesee99cd87-549f-4a43-878e-b4d5935de0e02025-12-19WarningsExact identifier
application number: M005
Fungi Nail Anti-Fungal PenTOLNAFTATEKramer Laboratories1a0a3b14-d8f2-4363-b3c9-f5028e8eada32025-12-19WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYWinco Foods, LLCcc257a18-247f-c787-e053-2a95a90a075a2025-12-16WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2288438ethanol 83 % Topical SprayPSN03010837-0289-3e08-e063-6394a90a7d042
2288438ethanol 0.83 ML/ML Topical SpraySCD03010837-0289-3e08-e063-6394a90a7d042
2288438ethanol 83 % Topical SpraySY03010837-0289-3e08-e063-6394a90a7d042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77039-024-0177039002401500 mL in 1 BOTTLE, SPRAY (77039-024-01) 500 ml2023-08-16NoNoCurrent