FDA.reportPublic FDA data

70%

Product NDC
53942-810
11-digit product format
539420810
Labeler code
53942
Product ID
53942-810_5de58d2b-b6f8-4bde-e063-6394a90a2bb4
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-11-24
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53942-81053942-810-72DDiscontinued by firm2026-10-23

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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
70%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-810-4370%473 mL in 1 BOTTLE, PLASTICLIQUID4737
53942-810-4570%946 mL in 1 BOTTLE, PLASTICLIQUID9467
53942-810-7270%295 mL in 1 BOTTLE, SPRAYLIQUID2957

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-81070% (ISOPROPYL ALCOHOL) LIQUID [DEMOULAS SUPER MARKETS, INC]6Current NDC, Legacy NDC, 3 package rows20250309_7cbd8ef5-9744-49ad-9640-d4c2b1ae8203.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 103 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb77267-73ad-efd2-e063-6294a90a43f72024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb7d6ca-ef7e-5225-e063-6294a90aa6922024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc8a756-852f-6cf8-e063-6394a90a57e62024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Vanilla 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc90b2f-450f-1deb-e063-6394a90a64802024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb4316d-c8c6-3fa2-e063-6394a90a23d22024-07-07WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltdf531053d-82e4-7613-e053-2995a90a349f2024-07-02WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd1ae5c268-1834-4ac2-931e-bb7fd0088cd22024-07-02WarningsExact identifier
application number: M003
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
application number: M003
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.dfff78d2-e23c-40b2-8a49-8f4140bb0df62024-06-25WarningsExact identifier
application number: M003
Walgreens 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEWalgreen Company03c497cc-c8b1-43b7-86ba-f9f9fc7432bf2024-06-18WarningsExact identifier
application number: M003
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
application number: M003
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
application number: M003
Antiseptic WipeBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1a3c5fc9-70cc-e857-e063-6294a90a34242024-06-06WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWildman Business Group1f95b277-e40c-4a17-e063-6294a90a11272024-06-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
application number: M003
MyMedic HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.197fc623-2fb9-184c-e063-6394a90a41042024-05-28WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN7cbd8ef5-9744-49ad-9640-d4c2b1ae82037
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD7cbd8ef5-9744-49ad-9640-d4c2b1ae82037
808520isopropyl alcohol 70 % Topical SolutionSY7cbd8ef5-9744-49ad-9640-d4c2b1ae82037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-810-4353942081043473 mL in 1 BOTTLE, PLASTIC (53942-810-43) 473 ml2003-11-240000-00-00NoNoCurrent
53942-810-4553942081045946 mL in 1 BOTTLE, PLASTIC (53942-810-45) 946 ml2003-11-240000-00-00NoNoCurrent
53942-810-7253942081072295 mL in 1 BOTTLE, SPRAY (53942-810-72) 295 ml2003-11-240000-00-00NoNoCurrent