High Five

Product NDC
49557-221
11-digit product format
495570221
Labeler code
49557
Product ID
49557-221_1a602bf9-674c-4705-bb9b-91f6dd1b6b4a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Jani-Source, LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49557-221DDiscontinued by firm2026-10-05
excluded packagepackage49557-22149557-221-05DDiscontinued by firm2026-10-05

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 5 · 248 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49557-221-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49557-221-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49557-221-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49557-221-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49557-221-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49557-221-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49557-221-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49557-221-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49557-221-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49557-221-05DDiscontinued by firmad56d346431e…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 packagepackage49557-221-15IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-17IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-07IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-13IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-06IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-24IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-55IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-28IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-11IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-10IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-08IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-14IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-09IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-12IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49557-221-27IInactivated 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 packagepackage49557-221-15IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-17IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-07IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-13IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-06IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-24IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-55IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-28IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-11IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-03IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-10IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-08IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-14IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-12IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49557-221-27IInactivated 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 packagepackage49557-221-15IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49557-221-012024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-032024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-052024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-062024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-072024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-082024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-092024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-102024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-112024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-122024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-132024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-142024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-152024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-172024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-242024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-272024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-282024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-552024-11-06High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-012020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-032020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-052020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-062020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-072020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-082020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-092020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-102020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-112020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-122020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-132020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-142020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-152020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-172020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-242020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-272020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-282020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label
49557-221-552020-01-31High Five Instant Hand Sanitizer 6605 Drug Facts and Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
ALCOHOLACTIVE MOIETY3K9958V90MHIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8HIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208HIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
DIISOPROPYLAMINEINACTIVE INGREDIENTBR9JLI40NOHIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHIGH FIVE (ALCOHOL) GEL [JANI-SOURCE, LLC]2