FDA.reportPublic FDA data

Sterile Alcohol

Product NDC
63868-980
11-digit product format
638680980
Labeler code
63868
Product ID
63868-980_2ad55938-0101-3a3f-e063-6394a90af7f5
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Chain Drug Marketing Association Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-30
Marketing end
2026-11-30
Substance
ISOPROPYL ALCOHOL
Active strength
.7 mL/1
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-980-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-980-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-980-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63868-980-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63868-980-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63868-980-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-980-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63868-980-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63868-980-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Sterile Alcohol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL.7 mL/1

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
55922632-3768-4450-9389-ba7d7d91f2c9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-01-0363868-980 Chain Drug Marketing Association IPA Pad
2024-01-3063868-980 Chain Drug Marketing Association IPA Pad
2021-01-2563868-980 Chain Drug Marketing Association IPA Pad
2020-01-3163868-980 Chain Drug Marketing Association IPA Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-980-01Sterile Alcohol1 in 1 PACKETSWAB18
63868-980-01Sterile Alcohol100 in 1 BOXSWAB1008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]3
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]3
WATERINACTIVE INGREDIENT059QF0KO0RSTERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-980STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]8Current NDC, Legacy NDC, 2 package rows20250105_55922632-3768-4450-9389-ba7d7d91f2c9.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 42 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDiscount Drug Mart37a6c0fb-e9c4-4a95-9539-ca5766b3a7012026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLDiscount Drug Mart7ac6b062-b471-4653-9d6f-de2ca8f8b0142026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDiscount Drug Mart7663654d-3697-40aa-8357-0978be7773a42026-01-12WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.88e6418c-ceb3-4bd6-8765-b476d8bf3ff32026-01-12WarningsExact identifier
application number: M003
WISH HYDROGEN PEROXIDEWISH HYDROGEN PEROXIDE 3%CLICK PRODUCTS LLC48370aaa-da08-a2ef-e063-6394a90a62b32026-01-12WarningsExact identifier
application number: M003
SANMO-BLMOISTURIZING SANITIZER WITH BLUE BEADSBeacon Promotions, Inc.1eb96fb8-d750-9241-e063-6394a90a1cdd2026-01-12WarningsExact identifier
application number: M003
Unscented SanitizerUNSCENTED SANITIZERBeacon Promotions, Inc.1f96aecf-8ca2-aa27-e063-6394a90abb792026-01-12WarningsExact identifier
application number: M003
Scented Hand SanitizerSCENTED HAND SANITIZERBeacon Promotions, Inc.1f95444c-7587-a07e-e063-6394a90af5342026-01-12WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.6d472aef-0d95-4c21-a373-bd16bc7b63ed2026-01-12WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.3cce065a-0254-43ad-a96f-aae6979997be2026-01-12WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.b58145c6-0f6c-5a47-e053-2995a90a5d7f2026-01-09WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Inc.b5815ca2-edaa-bc8c-e053-2a95a90a3df22026-01-09WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLJC SALES1f3466d2-6a2e-f871-e063-6394a90af0852026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products1e2cb45c-7e70-01dd-e063-6294a90aa16b2026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products063a1e99-dda6-9cb9-e063-6294a90aa1b32026-01-09WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.04ac8597-00fa-458f-a929-ada5042a8c382026-01-09WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMXCHLOROXYLENOLXinxiang Xinda Technology Co.,Ltd125b3c3b-0a3a-9fd3-e063-6394a90a135a2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd125a49c3-15c0-fbad-e063-6394a90a5d2e2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHGCHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd125ac9df-03db-83e9-e063-6394a90afeab2026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN55922632-3768-4450-9389-ba7d7d91f2c98
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD55922632-3768-4450-9389-ba7d7d91f2c98
797544isopropyl alcohol 70 % Medicated PadSY55922632-3768-4450-9389-ba7d7d91f2c98
797544isopropyl alcohol 70 % Topical ClothSY55922632-3768-4450-9389-ba7d7d91f2c98
797544isopropyl alcohol 70 % Topical SwabSY55922632-3768-4450-9389-ba7d7d91f2c98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-980-0163868098001100 PACKET in 1 BOX (63868-980-01) / 1 SWAB in 1 PACKET100 packet2017-03-102026-11-30NoNoCurrent