FDA.reportPublic FDA data

Isopropyl Alcohol 91 Percent

Product NDC
82645-914
11-digit product format
826450914
Labeler code
82645
Product ID
82645-914_0d1cfe14-52e7-8975-e063-6294a90afbb7
Type
HUMAN OTC DRUG
Nonproprietary name
isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
ISOPROPYL ALCOHOL
Active strength
910 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 Alcohol 91 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL910 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
582901Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42f6c6d-c4e0-02c6-e053-2995a90a3aceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-914-16Isopropyl Alcohol 91 Percent473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-914ISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_e42f6c6d-c4e0-02c6-e053-2995a90a3ace.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 76 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.371ef8bb-9e3e-e5cc-e063-6394a90a4b6e2025-06-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer SpidermanALCOHOLShenzhen Lantern Scicence Co.,Ltd.371f6cbb-0164-e82d-e063-6294a90ae2df2025-06-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer --SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.371b5429-a392-02d0-e063-6294a90a7fe82025-06-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer TransformerALCOHOLShenzhen Lantern Scicence Co.,Ltd.371c47f6-ba88-4a7c-e063-6294a90a16972025-06-08WarningsExact identifier
application number: M003
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
application number: M003
Singular WipesALCOHOLSINGULAR ENTERPRISES LLC03957345-ccd0-4def-b528-7733e6a24cbb2025-06-06WarningsExact identifier
application number: M003
Travel WipesISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC818b4280-a1cb-4c69-908f-f687f7c84ad92025-06-06WarningsExact identifier
application number: M003
Singular Wipes lavender fragranceALCOHOLSINGULAR ENTERPRISES LLC9499fde0-ec1c-4880-b83b-62bc78686d992025-06-06WarningsExact identifier
application number: M003
Travel Wipes Moisturizer and fragranceALCOHOLSINGULAR ENTERPRISES LLC46024d13-84dd-47a9-af76-d2feba62448c2025-06-06WarningsExact identifier
application number: M003
The Pharma-C Company 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLKleen Test Products Corporationa0f93dac-7baa-4f79-b6a0-3cabe52806bb2025-06-04WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Apple Pear CloveETHYL ALCOHOL 70%MY IMPORTS USA LLC36a67d51-c80f-b8a9-e063-6394a90ac7be2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a68ecb-3216-eeb2-e063-6294a90a5bba2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%MY IMPORTS USA LLC36a7b358-131c-88fc-e063-6394a90a007f2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a7bbf0-166b-54dc-e063-6294a90a1c162025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Blissful Cherry, Candy Cane Cocoa, Molten Marshmallows)ALCOHOLScent Theory Products LLC36b0eec0-33b2-2055-e063-6394a90af7302025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Pink Champagne, Harvest Berry, Cozy Coconut)ALCOHOLScent Theory Products LLC36b105ef-82a5-7f95-e063-6394a90a8c1b2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%MY IMPORTS USA LLC36b4fb1c-9b19-63c3-e063-6394a90a5e352025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b55178-6f31-85a9-e063-6394a90a56bc2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b5ebda-1448-bc40-e063-6294a90af6d42025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b63138-8ec9-e84a-e063-6394a90a68e32025-06-03WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSNe42f6c6d-c4e0-02c6-e053-2995a90a3ace2
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCDe42f6c6d-c4e0-02c6-e053-2995a90a3ace2
582901isopropyl alcohol 91 % Topical SolutionSYe42f6c6d-c4e0-02c6-e053-2995a90a3ace2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-914-1682645091416473 mL in 1 BOTTLE (82645-914-16) 473 ml2016-01-010000-00-00NoNoCurrent