Home NDC 51628-1016 AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN
Product NDC 51628-1016
11-digit product format 516281016
Labeler code 51628
Product ID 51628-1016_29a2bd52-0ac0-d1af-e063-6394a90a2743
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol
Dosage form LIQUID
Route TOPICAL
Labeler MY IMPORT USA INC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-11
Substance ISOPROPYL 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 AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOPROPYL 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 ND2M416302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 808520 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 51628-1016-1 AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 2 51628-1016-2 AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51628-1016 AMORAY 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [MY IMPORT USA INC] 2 Current NDC, Legacy NDC, 2 package rows 20241222_8e52e75f-717a-4829-b1aa-f35cf1981af8.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 103 of 114 · 2,270 matching rows.
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 51628-1016-1 51628101601 355 mL in 1 BOTTLE, PLASTIC (51628-1016-1) 355 ml 2020-08-11 0000-00-00 No No Current 51628-1016-2 51628101602 473 mL in 1 BOTTLE, PLASTIC (51628-1016-2) 473 ml 2020-08-11 0000-00-00 No No Current