FDA.reportPublic FDA data

Medline Alcohol Prep

Product NDC
53329-811
11-digit product format
533290811
Labeler code
53329
Product ID
53329-811_41483c3f-f207-027f-e063-6394a90aea68
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
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
Medline Alcohol Prep
Brand name suffix
Sterile, Large
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
c9fae7b6-2f4b-490b-9b17-a7297e738069Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-811-092023-08-08811 Alcohol Prep Pad
53329-811-092023-08-08811 Alcohol Prep Pad
53329-811-302023-08-08811 Alcohol Prep Pad
53329-811-302023-08-08811 Alcohol Prep Pad
53329-811-092023-07-28811 Alcohol Prep Pad
53329-811-092023-07-28811 Alcohol Prep Pad
53329-811-302023-07-28811 Alcohol Prep Pad
53329-811-302023-07-28811 Alcohol Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-811-09Medline Alcohol PrepSterile, Large5 mL in 1 APPLICATORSWAB514
53329-811-09Medline Alcohol PrepSterile, Large1 in 1 PACKETSWAB114
53329-811-30Medline Alcohol PrepSterile, Large100 in 1 BOXSWAB10014
53329-811-30Medline Alcohol PrepSterile, Large1 in 1 PACKETSWAB114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302MEDLINE ALCOHOL PREP STERILE, LARGE (ISOPROPYL ALCOHOL) SWAB [MEDLINE INDUSTRIES, INC.]4
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302MEDLINE ALCOHOL PREP STERILE, LARGE (ISOPROPYL ALCOHOL) SWAB [MEDLINE INDUSTRIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RMEDLINE ALCOHOL PREP STERILE, LARGE (ISOPROPYL ALCOHOL) SWAB [MEDLINE INDUSTRIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-811MEDLINE ALCOHOL PREP STERILE, LARGE (ISOPROPYL ALCOHOL) SWAB [MEDLINE INDUSTRIES, LP]13Current NDC, Legacy NDC, 4 package rows20241208_c9fae7b6-2f4b-490b-9b17-a7297e738069.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 111 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
application number: M003
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
application number: M003
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M003
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIALALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0c73f4f5-2b1d-84ae-e063-6394a90a5d7b2023-12-14WarningsExact identifier
application number: M003
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
application number: M003
GNP Idoinde Tincture 2% MildIODINE AND SODIUM IODIDE AND ALCOHOLAmerisource Bergen32ad75b8-abd1-4151-a035-b6c9ae5fc8882023-12-14WarningsExact identifier
application number: M003
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
application number: M003
AntiochPharma Rapidgel Hand SanitizerALCOHOLWeeks & Leo0c57a9ea-de66-3ced-e063-6294a90a4b8d2023-12-12WarningsExact identifier
application number: M003
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
application number: M003
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
application number: M003
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
application number: M003
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
application number: M003
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
application number: M003
FIRSTAR Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.49a86020-b888-423f-99a5-02fa938105ec2023-11-15WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Health4678074a-16f1-5480-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M003
Care One 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLAhold U.S.A., Inc.607b6917-2880-4b1c-83c6-f1297a828ecc2023-11-10WarningsExact identifier
application number: M003
Topcare 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDETopco Associates LLCdc4b07b6-6476-4e32-901a-da8115d6a1972023-11-10WarningsExact identifier
application number: M003
Topcare 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTopco Associates LLCbf9ee7da-69d9-47a2-8748-6b978ca3c2982023-11-10WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd40c7cfc6-ef3b-4759-b9e9-6d7e1319a8472023-11-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNc9fae7b6-2f4b-490b-9b17-a7297e73806914
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDc9fae7b6-2f4b-490b-9b17-a7297e73806914
797544isopropyl alcohol 70 % Medicated PadSYc9fae7b6-2f4b-490b-9b17-a7297e73806914
797544isopropyl alcohol 70 % Topical ClothSYc9fae7b6-2f4b-490b-9b17-a7297e73806914
797544isopropyl alcohol 70 % Topical SwabSYc9fae7b6-2f4b-490b-9b17-a7297e73806914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-811-09533290811091 APPLICATOR in 1 PACKET (53329-811-09) / 5 mL in 1 APPLICATOR1 applicator2007-01-010000-00-00NoNoCurrent
53329-811-3053329081130100 PACKET in 1 BOX (53329-811-30) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR100 packet2007-01-010000-00-00NoNoCurrent