Home NDC 78003-140 HydrAphex
Product NDC 78003-140
11-digit product format 780030140
Labeler code 78003
Product ID 78003-140_d5ccc62d-3d96-650c-e053-2a95a90a5e17
Type HUMAN OTC DRUG
Nonproprietary name HydrAphex
Dosage form SOLUTION
Route TOPICAL
Labeler Aphex Biocleanse Systems, Inc
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-06-01
Marketing end 2029-01-31
Substance BENZALKONIUM CHLORIDE
Active strength .0013 g/mL
NDC exclude flag No
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 HydrAphex Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .0013 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 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 78003-140-70 HydrAphex 208000 mL in 1 DRUM SOLUTION 208000 2 78003-140-80 HydrAphex 1045000 mL in 1 CONTAINER SOLUTION 1045000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78003-140 HYDRAPHEX SOLUTION [APHEX BIOCLEANSE SYSTEMS, INC] 2 Current NDC, Legacy NDC, 2 package rows 20220118_a6035c7d-0f5b-3295-e053-2995a90af89c.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78003-140-70 78003014070 208000 mL in 1 DRUM (78003-140-70) 208000 ml 2020-06-01 2029-01-31 No No Current 78003-140-80 78003014080 1045000 mL in 1 CONTAINER (78003-140-80) 1045000 ml 2020-06-01 2029-01-31 No No Current