Home NDC 55319-778 FB HYDRATING HAND SANITIZER
Product NDC 55319-778
11-digit product format 553190778
Labeler code 55319
Product ID 55319-778_426b0a14-8042-5182-e063-6394a90a216c
Type HUMAN OTC DRUG
Nonproprietary name FB HYDRATING HAND SANITIZER
Dosage form GEL
Route TOPICAL
Labeler FAMILY DOLLAR SERVICES, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-28
Substance ALCOHOL
Active strength 70 g/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 FB HYDRATING HAND SANITIZER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 70 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-778-01 FB HYDRATING HAND SANITIZER 50 mL in 1 BOTTLE GEL 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-778 FB HYDRATING HAND SANITIZER GEL [FAMILY DOLLAR SERVICES, LLC] 2 Current NDC, 1 package rows 20250322_20b650bd-18fe-8696-e063-6394a90aa9a2.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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-778-01 55319077801 50 mL in 1 BOTTLE (55319-778-01) 50 ml 2024-08-28 No No Current