FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
49580-4162
11-digit product format
495804162
Labeler code
49580
Product ID
49580-4162_7565f8f4-565f-4bd0-b726-415c2f4297b5
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
P & L Development, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-30
Substance
ISOPROPYL ALCOHOL
Active strength
91 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
Brand name suffix
91 percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL91 mL/100mL

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
fcda76cb-63c4-4e81-9e0a-13be506a8150Available on FDA.report

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 106 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Hand Sanitizer Moisurize with Vitamin E and AloeETHYL ALCOHOLRejoice International2851ad2a-e108-424c-86d6-c898567695ef2024-02-28WarningsExact identifier
application number: M003
XtraCare Hand Sanitizer Moisturize with Vitamin EETHYL ALCOHOLRejoice International13c99570-0859-4310-843a-5eb266698eb32024-02-28WarningsExact identifier
application number: M003
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationala339dfd9-7cb8-4198-bc2a-9759648cf34e2024-02-28WarningsExact identifier
application number: M003
XtraCare Instant Hand SanitizerETHYL ALCOHOLRejoice Internationalf15a90e2-4a1e-452a-b9ac-5eb6f7b3dc722024-02-28WarningsExact identifier
application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd11ef87cc-6ff6-511b-e063-6294a90a662f2024-02-21WarningsExact identifier
application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZERETHYL ALCOHOLMY IMPORTS USA LLC11f19126-6abb-b14c-e063-6294a90a4e342024-02-21WarningsExact identifier
application number: M003
AntisepticANTISEPTIC SPRAYDynarex Corporation118192ac-7173-09c5-e063-6394a90ad5502024-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL SPRAYDynarex Corporation116e0c9c-cbe0-bf67-e063-6394a90ae5302024-02-15WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEHART Health92b6a38e-c7bb-45e2-9c2a-7993ed1bac362024-02-15WarningsExact identifier
application number: M003
Povidone Iodine Gel SwabstickPOVIDONE IODINE GEL SWABSTICKDynarex Corporationeb7e21be-521e-2d52-e053-2a95a90ade332024-02-13WarningsExact identifier
application number: M003
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINESafetec of America, Inc.458e65f2-826d-4550-8c7d-17add2d7ba9a2024-02-07WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESafetec of America, Inc.a665e2ce-c7e1-4d79-aa58-da7595944e7f2024-02-07WarningsExact identifier
application number: M003
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.47cb6921-5d82-4123-a9e0-0b05d4dcb5b22024-02-07WarningsExact identifier
application number: M003
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.0fbf0078-3660-fe5c-e063-6394a90afc2d2024-01-25WarningsExact identifier
application number: M003
Hand sanitizer 8oz with aloe veraETHYL ALCOHOL 70%V/VMidwood Brands, LLC0fc032af-26bc-0e8b-e063-6294a90a91b02024-01-25WarningsExact identifier
application number: M003
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOLMidwood Brands, LLC0fc0bd79-ddd7-b9d1-e063-6394a90adc692024-01-25WarningsExact identifier
application number: M003
Hand sanitizer 8oz with vitamin EETHYL ALCOHOL 70%V/VMidwood Brands, LLC0fc0970d-06a6-ade9-e063-6394a90ae7ff2024-01-25WarningsExact identifier
application number: M003
Target Up and Up Pain Relieving CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDETARGET CORPORATION0f964747-be02-c715-e063-6294a90ad91e2024-01-25WarningsExact identifier
application number: M003
SannyTize Hand SanitizerHAND SANITIZERDynarex Corporation968713a5-64d3-86fc-e053-2995a90a088a2024-01-24WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
49580-4162-2495804162022 BOTTLE, PLASTIC in 1 PACKAGE (49580-4162-2) / 32 mL in 1 BOTTLE, PLASTIC2026-06-30NoNoCurrent