FDA.reportPublic FDA data

Alcohol Prep

Product NDC
76162-809
11-digit product format
761620809
Labeler code
76162
Product ID
76162-809_0d7ffc64-5322-ba5d-e063-6294a90a6cac
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Topco Associates
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-13
Marketing end
2026-12-31
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76162-809-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76162-809-309bebd1f3094a…5416666fcb17…

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
Alcohol Prep

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
65270825-48b1-49e7-a14e-f73df9beb9ddAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76162-809-302021-01-15C16284748780-19d75b9cf-e3f0-f424-e053-dadaa90a57ce76162-809 Top Care IPA Pads
76162-809-302020-01-31C16284748780-19d75b9cf-e3f0-f424-e053-dadaa90a57ce76162-809 Top Care IPA Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-809-30Alcohol Prep1 in 1 PACKETSWAB17
76162-809-30Alcohol Prep100 in 1 BOXSWAB1007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [TOPCO ASSOCIATES]3
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [TOPCO ASSOCIATES]3
WATERINACTIVE INGREDIENT059QF0KO0RALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [TOPCO ASSOCIATES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-809ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [TOPCO ASSOCIATES]7Current NDC, Legacy NDC, 2 package rows20231228_65270825-48b1-49e7-a14e-f73df9beb9dd.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 PadPSN65270825-48b1-49e7-a14e-f73df9beb9dd7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD65270825-48b1-49e7-a14e-f73df9beb9dd7
797544isopropyl alcohol 70 % Medicated PadSY65270825-48b1-49e7-a14e-f73df9beb9dd7
797544isopropyl alcohol 70 % Topical ClothSY65270825-48b1-49e7-a14e-f73df9beb9dd7
797544isopropyl alcohol 70 % Topical SwabSY65270825-48b1-49e7-a14e-f73df9beb9dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76162-809-3076162080930100 PACKET in 1 BOX (76162-809-30) / 1 APPLICATOR in 1 PACKET / .5 mL in 1 APPLICATOR100 packet2011-07-132026-12-31NoNoCurrent