FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
11344-864
11-digit product format
113440864
Labeler code
11344
Product ID
11344-864_5c141a3a-268a-1cea-e063-6294a90a6947
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-07-15
Substance
ISOPROPYL ALCOHOL
Active strength
50 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
Isopropyl Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 mL/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-864-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11344-864-43ML - Milliliter11344-8643fbed488-9fa0-4b7f-a7a9-d47e109770b312024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-864ISOPROPYL ALCOHOL LIQUID [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250410_4b7eca80-5f46-41be-abcb-a1f924667728.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 86 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Cucumber MelonETHYL ALCOHOLRejoice International021fa2a0-d2ea-4699-a3d8-3c0af18c5aa32025-02-12WarningsExact identifier
application number: M003
XtraCare Lavender ChamomileETHYL ALCOHOLRejoice International6e611e87-1835-49f8-aa52-b724bd2515272025-02-12WarningsExact identifier
application number: M003
XtraCare Sweet Pea BlossomETHYL ALCOHOLRejoice International1a5408f2-910c-4c6a-b6b3-c1304dd1cdf02025-02-12WarningsExact identifier
application number: M003
XtraCare Warm VanillaETHYL ALCOHOLRejoice International46e7b4fa-3722-4487-9325-f8552ea92acf2025-02-12WarningsExact identifier
application number: M003
Instant Hand Sanitizer 2oz Bonus packETHYL ALCOHOLRejoice International Inc.5b209df6-d896-170c-e053-2a91aa0a52a82025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Strawberry Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e62eb50-ebb8-361e-e053-2991aa0aba6f2025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Lemon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e6585a3-61e1-30ec-e053-2a91aa0a60392025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Spider Man 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dedab76-3f5a-febf-e063-6394a90a69932025-02-12WarningsExact identifier
application number: M003
Hand Sanitizer w/ Carabiner (Watermelon Scented) 2oz Bonus packETHYL ALCOHOLRejoice International Inc.6e65856c-0e14-1ab6-e053-2991aa0a3f3e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Barbie 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd2ffd-a85a-f63e-e063-6294a90a6a5e2025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Crayola 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfd4acb-451b-12d3-e063-6294a90a48732025-02-12WarningsExact identifier
application number: M003
Smart Care Assorted Licensed Sanitizer Hot Wheels 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfdd225-24f4-6d57-e063-6394a90a8a242025-02-12WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2dfe0ac7-99d5-aac3-e063-6294a90a31b32025-02-12WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
application number: M003
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e042f5b-3f0c-1830-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e04fa70-c25d-4499-e054-00144ff8d46c2025-02-06WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e05cceb-b8f3-48f7-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz AntisepticETHYL ALCOHOLREJOICE INTERNATIONAL CORP.a0313f20-11dc-6c7d-e053-2a95a90a60f12025-02-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2600350isopropyl alcohol 50 % Topical SprayPSN4b7eca80-5f46-41be-abcb-a1f9246677283
2600350isopropyl alcohol 0.5 ML/ML Topical SpraySCD4b7eca80-5f46-41be-abcb-a1f9246677283
2600350isopropyl alcohol 50 % Topical SpraySY4b7eca80-5f46-41be-abcb-a1f9246677283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-864-4311344086443473 mL in 1 BOTTLE, PLASTIC (11344-864-43) 473 ml1989-07-15NoNoCurrent