FDA.reportPublic FDA data

Isopropyl Rubbing Alcohol

Product NDC
0404-0002
11-digit product format
004040002
Labeler code
0404
Product ID
0404-0002_47e65223-4673-2b48-e063-6394a90a7e6d
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Henry Schein Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-01
Substance
ISOPROPYL ALCOHOL
Active strength
700 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
Isopropyl Rubbing Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL700 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeaf255e-497b-4672-bebc-4d3fcba904c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0002-01Isopropyl Rubbing Alcohol3785 mL in 1 BOTTLE, PLASTICSOLUTION378512
0404-0002-16Isopropyl Rubbing Alcohol473 mL in 1 BOTTLE, PLASTICSOLUTION47312
0404-0002-32Isopropyl Rubbing Alcohol946 mL in 1 BOTTLE, PLASTICSOLUTION94612

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isopropyl AlcoholACTIVE INGREDIENTND2M416302ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0002ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) SOLUTION [HENRY SCHEIN INC.]11Current NDC, Legacy NDC, 3 package rows20241116_eeaf255e-497b-4672-bebc-4d3fcba904c7.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 64 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Feels Hand SanitizerFRESH FEELS HAND SANITIZERZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3e36e2c4-fe4d-d517-e063-6394a90ac4be2025-09-25WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEJell Pharmaceuticals Pvt Ltd.ddc59e50-083a-6cd9-e053-2995a90ad4012025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(CHERRY)HAND SANITIZER(CHERRY)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6cc842-8b54-9a27-e063-6294a90a1dd52025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(PEACH)HAND SANITIZER(PEACH)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6bf6be-5328-8151-e063-6294a90a82112025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(COCONUT)HAND SANITIZER(COCONUT)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6ca090-98d9-4650-e063-6294a90a35c02025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(MANGO)HAND SANITIZER(MANGO)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6c79b9-d4b1-bbaf-e063-6394a90a11002025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Matcha MoodALCOHOLScent Theory Products LLC3f8fc09d-863d-0c13-e063-6394a90a49682025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Ocean MistALCOHOLScent Theory Products LLC3f8fd236-e413-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Sunrise CitrusALCOHOLScent Theory Products LLC3f8fd236-e415-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Velvet VanillaALCOHOLScent Theory Products LLC3f8fdb54-2e2c-2cab-e063-6394a90a1f092025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Sun-Kissed MelonALCOHOLScent Theory Products LLC3f8fe3c4-1373-b45a-e063-6294a90ae05b2025-09-24WarningsExact identifier
application number: M003
First Aid Direct Hand SanitizerHAND SANITIZERCintas Corporationdad0fc5d-4a48-4db1-b423-558c2958750c2025-09-24WarningsExact identifier
application number: M003
Xpect Hydrogen PeroxideHYDROGEN PEROXIDECintas Corporation793afae4-5270-4be7-b41a-269b4e59bcad2025-09-23WarningsExact identifier
application number: M003
HUMCO 1 Percent IodineISOPROPYL ALCOHOLHumco Holding Group, Inc.139efeef-be20-4362-a5ba-158b8fa40e0d2025-09-22WarningsExact identifier
application number: M003
Xpect Isopropyl AlcoholISOPROPYL ALCOHOLCintas Corpb55fe473-45d2-48d3-b4d4-fc0993cb4dfe2025-09-22WarningsExact identifier
application number: M003
Xpect AntisepticBENZALKONIUM CHLORIDECintas Corporationd9a31a11-e80f-4ded-ad0a-34f93b01557e2025-09-22WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEMidwood Brands LLC3f2cea6a-269a-a19b-e063-6294a90a29a92025-09-19WarningsExact identifier
application number: M003
MOONIES Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEHangzhou Chunchi Touring Commodity Co., Ltd.3eee1a5c-e926-5251-e063-6294a90a5d2e2025-09-17WarningsExact identifier
application number: M003
MISTIFY SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3efef0a5-ff5e-f2b0-e063-6294a90a1efa2025-09-17WarningsExact identifier
application number: M003
MISTIFY SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3eff0ac8-1cf5-3681-e063-6294a90a87052025-09-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSNeeaf255e-497b-4672-bebc-4d3fcba904c712
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCDeeaf255e-497b-4672-bebc-4d3fcba904c712
808520isopropyl alcohol 70 % Topical SolutionSYeeaf255e-497b-4672-bebc-4d3fcba904c712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0002-01004040002013785 mL in 1 BOTTLE, PLASTIC (0404-0002-01) 3785 ml2014-06-010000-00-00NoNoCurrent
0404-0002-1600404000216473 mL in 1 BOTTLE, PLASTIC (0404-0002-16) 473 ml2014-06-010000-00-00NoNoCurrent
0404-0002-3200404000232946 mL in 1 BOTTLE, PLASTIC (0404-0002-32) 946 ml2014-06-010000-00-00NoNoCurrent