Home NDC 80684-117 b pure Hand Sanitizer Lemon Scented
Product NDC 80684-117
11-digit product format 806840117
Labeler code 80684
Product ID 80684-117_1bf7ad89-6a80-93c6-e063-6394a90a63f9
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form LIQUID
Route TOPICAL
Labeler FOURSTAR GROUP USA, INC.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-26
Substance ALCOHOL
Active strength 70 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 b pure Hand Sanitizer Lemon Scented
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 70 mL/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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1041849 Internal RxNorm 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 80684-117-00 b pure Hand Sanitizer Lemon Scented 59 mL in 1 BOTTLE LIQUID 59 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-117 B PURE HAND SANITIZER LEMON SCENTED (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.] 1 Current NDC, 1 package rows 20240726_3fc74eff-46d6-45f5-bfa5-76a6a923cb94.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80684-117-00 80684011700 59 mL in 1 BOTTLE (80684-117-00) 59 ml 2024-07-26 No No Current