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 98 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
application number: M003
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
application number: M003
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
application number: M003
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
application number: M003
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
application number: M003
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
application number: M003
Instant Hand SanitizerHAND SANITIZERRaining Rose, Inc.2656d129-df88-4489-e063-6394a90a4b492024-11-07WarningsExact identifier
application number: M003
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.0588ae1b-f29a-e1b6-e063-6394a90a0de12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeETHYL ALCOHOLWhole Foods Market, Inc.074334af-c26e-4126-e063-6394a90ae4c42024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.07f708d1-11c8-eb50-e063-6294a90a3a812024-11-02WarningsExact 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