FDA.reportPublic FDA data

alcohol

Product NDC
68786-122
11-digit product format
687860122
Labeler code
68786
Product ID
68786-122_47e7cce1-e8ad-4085-e063-6294a90ac003
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-25
Substance
ISOPROPYL ALCOHOL
Active strength
.7 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68786-122-018dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68786-122-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68786-122-01e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68786-122-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68786-122-019bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68786-122-029bebd1f3094a…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
Listing expiration
2027-12-31

Active Ingredients#

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

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
03d6c745-6ee3-4011-9d5d-c8a4f078ecedAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68786-122-012022-01-03Sion Biotext Medical Alcohol Swabstick
68786-122-012022-01-03Sion Biotext Medical Alcohol Swabstick
68786-122-022022-01-03Sion Biotext Medical Alcohol Swabstick
68786-122-022022-01-03Sion Biotext Medical Alcohol Swabstick
68786-122-012020-01-31Sion Biotext Medical Alcohol Swabstick
68786-122-012020-01-31Sion Biotext Medical Alcohol Swabstick
68786-122-022020-01-31Sion Biotext Medical Alcohol Swabstick
68786-122-022020-01-31Sion Biotext Medical Alcohol Swabstick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-122-01alcohol3 mL in 1 POUCHSWAB36
68786-122-01alcohol50 in 1 BOXSWAB506
68786-122-02alcohol25 in 1 BOXSWAB256
68786-122-02alcohol9 mL in 1 POUCHSWAB96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-122ALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]5Current NDC, Legacy NDC, 4 package rows20240125_03d6c745-6ee3-4011-9d5d-c8a4f078eced.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 32 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS0cc6b001-4982-40ee-a476-151f86c14a8e2026-02-19WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESave-A-Lot Food Stores Ltde279b23d-6779-4f04-a93c-1c2a495596392026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEMeijer, Inc.193292da-390b-4430-91b1-1d159ac505072026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMeijer, Inc.4989f1cd-4555-405a-a5f8-8714d472983c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETarget Corporation78693ec1-d725-408c-bb95-2261faad84ac2026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsExact identifier
application number: M003
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
application number: M003
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS8a9848b0-19df-455a-9984-5ea2e5ce1b9f2026-02-17WarningsExact identifier
application number: M003
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
application number: M003
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
application number: M003
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
application number: M003
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
application number: M003
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnited Natural Foods, Inc. dba UNFI8a44aa29-58d6-4971-b572-4579f03ed2272026-02-17Warnings, Adverse reactionsExact identifier
application number: M003
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN03d6c745-6ee3-4011-9d5d-c8a4f078eced6
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD03d6c745-6ee3-4011-9d5d-c8a4f078eced6
797544isopropyl alcohol 70 % Medicated PadSY03d6c745-6ee3-4011-9d5d-c8a4f078eced6
797544isopropyl alcohol 70 % Topical ClothSY03d6c745-6ee3-4011-9d5d-c8a4f078eced6
797544isopropyl alcohol 70 % Topical SwabSY03d6c745-6ee3-4011-9d5d-c8a4f078eced6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-122-016878601220150 POUCH in 1 BOX (68786-122-01) / 3 mL in 1 POUCH50 pouch2014-04-280000-00-00NoNoCurrent
68786-122-026878601220225 POUCH in 1 BOX (68786-122-02) / 9 mL in 1 POUCH25 pouch2014-04-280000-00-00NoNoCurrent