Home NDC 55319-116 Hand sanitizer 8oz with vitamin E
Product NDC 55319-116
11-digit product format 553190116
Labeler code 55319
Product ID 55319-116_0fc0970d-06a7-ade9-e063-6394a90ae7ff
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol 70%V/V
Dosage form LIQUID
Route TOPICAL
Labeler Midwood Brands, LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-25
Substance ALCOHOL
Active strength 70 mL/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Hand sanitizer 8oz with vitamin E
Listing expiration 2027-12-31 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 582753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-116-01 Hand sanitizer 8oz with vitamin E 236 mL in 1 BOTTLE LIQUID 236 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-116 HAND SANITIZER 8OZ WITH VITAMIN E (ETHYL ALCOHOL 70%V/V) LIQUID [MIDWOOD BRANDS, LLC] 1 Current NDC, 1 package rows 20240126_0fc0970d-06a6-ade9-e063-6394a90ae7ff.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 99 of 114 · 2,275 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 55319-116-01 55319011601 236 mL in 1 BOTTLE (55319-116-01) 236 ml 2024-01-25 No No Current