FDA.reportPublic FDA data

Instant Hand Antiseptic

Product NDC
59448-008
Requested package NDC
59448-008-01
11-digit product format
594480008
Labeler code
59448
Product ID
59448-008_dcc29c32-04fb-49c5-8ce3-7bc2cdff346a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ASP Global
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Instant Hand Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9aca3f89-cdde-430c-8eb6-43a3ac3fc0dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-008-01Wellstar Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-008-01Instant Hand Antiseptic53 mL in 1 BOTTLE, PLASTICGEL532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-008WELLSTAR AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC20241222_ced9dd96-7922-43d7-906f-32afaad733ec.zip
59448-008INSTANT HAND ANTISEPTIC (ALCOHOL) GEL [ASP GLOBAL]2Current NDC, Legacy NDC, 1 package rows20241208_9aca3f89-cdde-430c-8eb6-43a3ac3fc0df.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 74 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.502b09be-b7e6-4ad7-be17-4c8b0e93b4ab2025-07-07WarningsExact identifier
application number: M003
Signature Select isopropyl alcohol wipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.97272c57-88f0-40d9-b11f-d53cb806ee732025-07-04WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENT WINTERGREENISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83f562-7ec7-72f3-e063-6294a90aba4d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83e678-b79f-6dd6-e063-6294a90ad09d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 70 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4babe369-3a35-34b5-e063-6394a90a68322025-07-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38c323e2-9a9a-f898-e063-6394a90aa2262025-06-30WarningsExact identifier
application number: M003
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
application number: M003
HAND SANITIZER FRESH LINENALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e492b-0690-a345-e063-6294a90aef2c2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e98dd-22ec-d4a3-e063-6394a90a80fa2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER STRAWBERRY FIZZALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e3045-14dc-ac2e-e063-6394a90a9b8a2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760c-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760e-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b87b19-7663-d5c5-e063-6294a90a9e872025-06-29WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Passion FruitALCOHOLShenzhen Lantern Scicence Co.,Ltd.38895b60-f5a8-880f-e063-6394a90aa7062025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -HibiscusALCOHOLShenzhen Lantern Scicence Co.,Ltd.3889d467-b179-bac4-e063-6394a90a61562025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize -Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.388a975c-b0b6-b80e-e063-6294a90a18142025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.388abca3-12fb-449a-e063-6394a90aea982025-06-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERugby Laboratoriesb2bcb69e-8ffb-23ee-e053-2995a90aee212025-06-27WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3874c203-2c8b-79b3-e063-6294a90aedfb2025-06-26WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % ToothpastePSNced9dd96-7922-43d7-906f-32afaad733ec4
581660ethanol 0.62 ML/ML Topical GelSCDced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDced9dd96-7922-43d7-906f-32afaad733ec4
581660ethanol 62 % Topical GelSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYced9dd96-7922-43d7-906f-32afaad733ec4
581660ethanol 62 % Topical GelPSN9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2
581660ethanol 0.62 ML/ML Topical GelSCD9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2
581660ethanol 62 % Topical GelSY9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-008-015944800080153 mL in 1 BOTTLE, PLASTIC (59448-008-01) 53 ml2021-10-010000-00-00NoNoCurrent