FDA.reportPublic FDA data

Isopropyl

Product NDC
11344-112
11-digit product format
113440112
Labeler code
11344
Product ID
11344-112_5c1338df-af91-ac32-e063-6394a90ad38f
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
2024-04-11
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
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
11344-112-43Isopropyl473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-112ISOPROPYL (ISOPROPYL ALCOHOL) LIQUID [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250410_15d5e873-32bb-40ed-e063-6394a90adf0d.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 89 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Up and Up Max Pain Relieving CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDETARGET CORPORATION2c3e72eb-5d98-1f3f-e063-6394a90ab00c2025-01-21WarningsExact identifier
application number: M003
Sierrasoft Clear Antibacterial Wash FoamCHLOROXYLENOLCWGC LA Inc.013a36fa-5a9a-46ea-b9d0-ac366257612e2025-01-20WarningsExact identifier
application number: M003
TM TITUS MEDICAL ANTISEPTIC Non SterilePOVIDONE-IODINETitus Medical LLC690b87d0-d889-43c6-b99e-cd9f26fd682a2025-01-17WarningsExact identifier
application number: M003
TM Titus Medical Povidone IodinePOVIDONE-IODINETitus Medical LLCaf7840c0-239e-4ff6-8d27-614e7d71ca992025-01-17WarningsExact identifier
application number: M003
Smart Care Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1b125c5d-7041-c71b-e063-6394a90add9b2025-01-17WarningsExact identifier
application number: M003
Berry Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f128054-4c57-8055-e063-6294a90adc4e2025-01-17WarningsExact identifier
application number: M003
ROAME Moisturizing Hand Sanitizer Cloud 999ALCOHOL HAND SANITIZERRoame LLC2bb1003e-8e4c-8dd8-e063-6294a90ad37d2025-01-14WarningsExact identifier
application number: M003
Antiseptic TowelettesBENZALKONIUM CHLORIDECMC Group Inc.d7470f98-4278-415b-92e7-9eca2036bc092025-01-13WarningsExact identifier
application number: M003
Alcohol CleansingISOPROPYL ALCOHOLCMC Group Inc.e3985ef1-503a-4193-a5b5-7910aefa78142025-01-13WarningsExact identifier
application number: M003
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
application number: M003
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN15d5e873-32bb-40ed-e063-6394a90adf0d3
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD15d5e873-32bb-40ed-e063-6394a90adf0d3
616456isopropyl alcohol 50 % Topical SolutionSY15d5e873-32bb-40ed-e063-6394a90adf0d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-112-4311344011243473 mL in 1 BOTTLE, PLASTIC (11344-112-43) 473 ml2024-04-11NoNoCurrent