FDA.reportPublic FDA data

Medline Alcohol Prep

Product NDC
53329-805
11-digit product format
533290805
Labeler code
53329
Product ID
53329-805_41489446-e231-53ab-e063-6394a90a9ed0
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-805DDiscontinued by firm2026-10-16
excluded packagepackage53329-80553329-805-60DDiscontinued by firm2026-10-16

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-805-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-805-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-805-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-805-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-805-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-805-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-805-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-805-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-805-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-805-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53329-805-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53329-805-60557ba5c1ecfa…9c80585c8c6e…

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, Medium
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
9a8584e1-b422-4b77-8464-4e022d578fadAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-805-092023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-092023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-302023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-302023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-572023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-572023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-602023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-602023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-862023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-862023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-972023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-972023-08-08805 Medline Sterile Isopropyl Prep Pads
53329-805-092023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-092023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-302023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-302023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-572023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-572023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-602023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-602023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-862023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-862023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-972023-07-28805 Medline Sterile Isopropyl Prep Pads
53329-805-972023-07-28805 Medline Sterile Isopropyl Prep Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-805-09Medline Alcohol PrepSterile, Medium1 in 1 PACKETSWAB120
53329-805-09Medline Alcohol PrepSterile, Medium5 mL in 1 APPLICATORSWAB520
53329-805-30Medline Alcohol PrepSterile, Medium1 in 1 PACKETSWAB120
53329-805-30Medline Alcohol PrepSterile, Medium100 in 1 BOXSWAB10020
53329-805-57Medline Alcohol PrepSterile, Medium1 in 1 PACKETSWAB120
53329-805-57Medline Alcohol PrepSterile, Medium12 in 1 PACKAGESWAB1220
53329-805-60Medline Alcohol PrepSterile, Medium1 in 1 PACKETSWAB120
53329-805-60Medline Alcohol PrepSterile, Medium200 in 1 BOXSWAB20020
53329-805-86Medline Alcohol PrepSterile, Medium1 in 1 PACKETSWAB120
53329-805-86Medline Alcohol PrepSterile, Medium3984 in 1 CASESWAB398420
53329-805-97Medline Alcohol PrepSterile, Medium1 in 1 PACKETSWAB120
53329-805-97Medline Alcohol PrepSterile, Medium3000 in 1 CASESWAB300020
53329-805-60Xyliderm200 in 1 BOXSWAB70 mL in 100mL5
53329-805-60Xyliderm1 in 1 PACKETSWAB70 mL in 100mL5

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-805MEDLINE ALCOHOL PREP STERILE, MEDIUM (ISOPROPYL ALCOHOL) SWAB [MEDLINE INDUSTRIES, LP]19Current NDC, Legacy NDC, 12 package rows20241207_9a8584e1-b422-4b77-8464-4e022d578fad.zip
53329-805XYLIDERM (LIDOCAINE, ISOPROPYL ALCOHOL) KIT [PURETEK CORPORATION]5Current NDC, Legacy NDC20241215_fed45e06-cc4d-fbc5-e053-6294a90a1b19.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 57 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe8cdf841-cf56-26cc-e053-2995a90aab512025-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLCc17603f2-3548-4225-b611-216c2763e51f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc601d9ea-25ab-cd1d-e053-2995a90ae2522025-10-23WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCardinal Healthcc0a6e1e-ec95-cb48-e053-2a95a90ac0ce2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions, LLCd07d103d-420b-5307-e053-2995a90a14f52025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHtl-Strefa, Inc.d72ddf5a-72e7-c37d-e053-2995a90ad48b2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc92524fd-8b91-592d-e053-2a95a90a88c62025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLCardinal Health89852887-ae62-4277-b615-75663afb54362025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.b9826baa-b976-14c6-e053-2995a90a7d092025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCc9261c7f-9f8f-6476-e053-2a95a90a0e932025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLRugby Laboratoriesea28b27a-456e-4042-b769-f060727599332025-10-23WarningsExact identifier
application number: M003
School Health Sterile Alcohol Prep PadISOPROPYL ALCOHOLSchool Health Corporation718640e1-826b-4b65-a021-3f82cd4c983a2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLHenry Schein, Inc.215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN9a8584e1-b422-4b77-8464-4e022d578fad20
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD9a8584e1-b422-4b77-8464-4e022d578fad20
797544isopropyl alcohol 70 % Medicated PadSY9a8584e1-b422-4b77-8464-4e022d578fad20
797544isopropyl alcohol 70 % Topical ClothSY9a8584e1-b422-4b77-8464-4e022d578fad20
797544isopropyl alcohol 70 % Topical SwabSY9a8584e1-b422-4b77-8464-4e022d578fad20
797544isopropyl alcohol 70 % Medicated PadPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 5 % Medicated PatchPSNfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344lidocaine 0.05 MG/MG Medicated Patch [Lidocan]SBDfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 0.05 MG/MG Medicated PatchSCDfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Medicated PadSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Topical ClothSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
797544isopropyl alcohol 70 % Topical SwabSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
1745091lidocaine 5 % Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 0.05 MG/MG Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195
2642344Lidocan 5 % Medicated PatchSYfed45e06-cc4d-fbc5-e053-6294a90a1b195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-805-09533290805091 APPLICATOR in 1 PACKET (53329-805-09) / 5 mL in 1 APPLICATOR1 applicator2007-01-010000-00-00NoNoCurrent
53329-805-3053329080530100 PACKET in 1 BOX (53329-805-30) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR100 packet2007-01-010000-00-00NoNoCurrent
53329-805-575332908055712 PACKET in 1 PACKAGE (53329-805-57) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR12 packet2020-09-220000-00-00NoNoCurrent
53329-805-6053329080560200 PACKET in 1 BOX (53329-805-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR200 packet2007-01-010000-00-00NoNoCurrent
53329-805-86533290805863984 PACKET in 1 CASE (53329-805-86) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR3984 packet2007-01-010000-00-00NoNoCurrent
53329-805-97533290805973000 PACKET in 1 CASE (53329-805-97) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR3000 packet2007-01-010000-00-00NoNoCurrent