FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
81085-0002
11-digit product format
810850002
Labeler code
81085
Product ID
81085-0002_519bf30f-9975-4d96-b536-5ab1113651b9
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
CLOTH
Route
TOPICAL
Labeler
Sarnova, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-05
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 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
797544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62be13a6-da24-4ab0-b0f4-f2894324c20cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81085-0002-1Isopropyl Alcohol0.8 mL in 1 POUCHCLOTH0.83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81085-0002ISOPROPYL ALCOHOL CLOTH [SARNOVA, INC.]3Current NDC, Legacy NDC, 1 package rows20241213_62be13a6-da24-4ab0-b0f4-f2894324c20c.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 113 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE SCRUB SWABSTICK 3sPOVIDONE-IODINEJianerkang Medical Co., Ltd65783da9-acca-41c7-860b-1de108edc5832023-10-23WarningsExact identifier
application number: M003
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE PREP PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 70 % Medicated PadSY62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 70 % Topical ClothSY62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 70 % Topical SwabSY62be13a6-da24-4ab0-b0f4-f2894324c20c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81085-0002-181085000201.8 mL in 1 POUCH (81085-0002-1) 2022-04-050000-00-00NoNoCurrent