Home NDC 80499-100 Hygiene Clean Clean Cotton Hand Sanitizer
Product NDC 80499-100
11-digit product format 804990100
Labeler code 80499
Product ID 80499-100_08c08f83-9cb2-cad2-e063-6294a90aa787
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler USA Broom LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-16
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base Hygiene Clean Clean Cotton Hand Sanitizer
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii F5UM2KM3W7 Rxcui 1020365
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80499-100-01 Hygiene Clean Clean Cotton Hand Sanitizer 800 mL in 1 BAG LIQUID 800 3 80499-100-02 Hygiene Clean Clean Cotton Hand Sanitizer 6 in 1 BOX LIQUID 6 3 80499-100-02 Hygiene Clean Clean Cotton Hand Sanitizer 800 mL in 1 BAG LIQUID 800 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80499-100 HYGIENE CLEAN CLEAN COTTON HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [USA BROOM LLC] 3 Current NDC, Legacy NDC, 3 package rows 20231030_bda861a1-2e25-528c-e053-2a95a90a985e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80499-100-01 80499010001 800 mL in 1 BAG (80499-100-01) 800 ml 2021-03-16 0000-00-00 No No Current 80499-100-02 80499010002 6 BAG in 1 BOX (80499-100-02) / 800 mL in 1 BAG 6 bag 2021-03-16 0000-00-00 No No Current