Home NDC 0225-0611 BENZEDREX
Product NDC 0225-0611
11-digit product format 002250611
Labeler code 0225
Product ID 0225-0611_2888acff-4fa4-a9d7-e063-6394a90a7eda
Type HUMAN OTC DRUG
Nonproprietary name PROPYLHEXEDRINE
Dosage form INHALANT
Route NASAL
Labeler BF ASCHER AND CO INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-23
Substance PROPYLHEXEDRINE
Active strength 175 mg/1
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 BENZEDREX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPYLHEXEDRINE 175 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LQU92IU8LL Internal UNII 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 0225-0611-23 BENZEDREX 1 in 1 INHALER INHALANT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0225-0611 BENZEDREX (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC] 2 Current NDC, 1 package rows 20241208_00d8c237-3eee-1d9f-e063-6394a90aeb86.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 74 of 180 · 3,583 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0225-0611-23 00225061123 1 INHALANT in 1 INHALER (0225-0611-23) 1 inhalant 2023-06-23 No No Current