Home NDC 83878-101 Ultra Prep Alcohol Prep Pads
Product NDC 83878-101
11-digit product format 838780101
Labeler code 83878
Product ID 83878-101_516a4c90-f830-4299-a88d-a82dea5d0e9f
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl Alcohol
Dosage form CLOTH
Route TOPICAL
Labeler Quality Medical Products USA, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-15
Substance ISOPROPYL ALCOHOL
Active strength 70 mL/100mL
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 Ultra Prep Alcohol Prep Pads
Listing expiration 2026-12-31 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 797544 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 83878-101-11 Ultra Prep Alcohol Prep Pads 1 in 1 PACKET CLOTH 1 1 83878-101-11 Ultra Prep Alcohol Prep Pads 100 in 1 BOX CLOTH 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83878-101 ULTRA PREP ALCOHOL PREP PADS (ISOPROPYL ALCOHOL) CLOTH [QUALITY MEDICAL PRODUCTS USA, INC.] 1 Current NDC, 2 package rows 20240723_f81a63dd-a699-459f-ab52-f63a6550b680.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 83878-101-11 83878010111 100 PACKET in 1 BOX (83878-101-11) / 1 PACKAGE in 1 PACKET / .45 mL in 1 PACKAGE 100 packet 2024-07-15 No No Current