FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
55319-503
Requested package NDC
55319-503-02
11-digit product format
553190503
Labeler code
55319
Product ID
55319-503_b673291e-14c4-9b86-e053-2a95a90a8339
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Family Dollar Services Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-31
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…

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
55319-503-022023-01-30FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-082023-01-30FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-102023-01-30FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-172023-01-30FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-332023-01-30FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-022020-12-14FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-082020-12-14FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-102020-12-14FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-172020-12-14FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-332020-12-14FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-022020-09-27FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-082020-09-27FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-102020-09-27FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-172020-09-27FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-332020-09-27FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-022020-09-25FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-082020-09-25FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-102020-09-25FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-172020-09-25FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-332020-09-25FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-022020-07-22FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-082020-07-22FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-102020-07-22FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-172020-07-22FmlyDllrHndSntzrwthMstrzrs&VitEAlch62
55319-503-332020-07-22FmlyDllrHndSntzrwthMstrzrs&VitEAlch62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
ALCOHOLACTIVE MOIETY3K9958V90MHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-503HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E (ALCOHOL) GEL [FAMILY DOLLAR SERVICES INC.]4Legacy NDC20201216_18df3fa3-96fb-46be-8a50-6ea93b1451d8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-503-025531905030259 mL in 1 BOTTLE, PLASTIC (55319-503-02) 59 ml2012-08-310000-00-00NoNoCurrent