Home NDC 63533-645 Han-I-Size Unscented
Product NDC 63533-645
11-digit product format 635330645
Labeler code 63533
Product ID 63533-645_120e3e9e-0d6d-d80d-e063-6394a90ad7c4
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler Momar Incorporated
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-26
Substance ALCOHOL
Active strength .7 mL/mL
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 Han-I-Size Unscented
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL .7 mL/mL
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 581662 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 63533-645-14 Han-I-Size Unscented 3785 mL in 1 BOTTLE, PLASTIC GEL 3785 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63533-645 HAN-I-SIZE UNSCENTED (ALCOHOL) GEL [MOMAR INCORPORATED] 2 Current NDC, 1 package rows 20240305_12d843ae-8175-264d-e063-6294a90ac8c0.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 63533-645-14 63533064514 3785 mL in 1 BOTTLE, PLASTIC (63533-645-14) 3785 ml 2024-02-26 No No Current