FDA.reportPublic FDA data

alcohol

Product NDC
68786-122
Requested package NDC
68786-122-01
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68786-12268786-122-01IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68786-12268786-122-01IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68786-12268786-122-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…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 41 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoplast First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLCec93011d-7069-4021-8dd2-3d51eb6026e12026-01-13WarningsExact identifier
application number: M003
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 32ozWISH RUBBING ALCOHOL 32OZ 70%CLICK PRODUCTS LLC4836b564-0b8c-2fb4-e063-6394a90a9c4a2026-01-13WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDealMed Medical Supplies LLC6d1ddf10-8873-4781-9165-bb1c4bbccfc92026-01-13WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHydrox Laboratories6e5709b4-cc56-4768-b704-1d9b0e3efec72026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact identifier
application number: M003
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

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