Home NDC 63148-100 HDX
Product NDC 63148-100
11-digit product format 631480100
Labeler code 63148
Product ID 63148-100_50ec4d97-6524-3863-e063-6394a90a5694
Type HUMAN OTC DRUG
Nonproprietary name Ethyl Alcohol
Dosage form GEL
Route TOPICAL
Labeler Apollo Health and Beauty Care
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-22
Substance ALCOHOL
Active strength 700 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base HDX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 700 mg/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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63148-100-16 HDX 473 mL in 1 BOTTLE, PLASTIC GEL 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63148-100 HDX (ETHYL ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE] 4 Current NDC, Legacy NDC, 1 package rows 20240615_df0063b2-2e30-428e-b5cf-24e566c388c2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HDX ETHYL ALCOHOL Apollo Health and Beauty Care df0063b2-2e30-428e-b5cf-24e566c388c2 2026-05-03 Warnings Exact identifier ndc (product): 63148-100
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 63148-100-16 63148010016 473 mL in 1 BOTTLE, PLASTIC (63148-100-16) 473 ml 2021-03-22 0000-00-00 No No Current