Home NDC 83004-040 Terramed Just Think Comfort GynoCare BV Guard Intimate Wash
Product NDC 83004-040
11-digit product format 830040040
Labeler code 83004
Product ID 83004-040_53c13065-d6a0-9bb5-e063-6294a90ac630
Type HUMAN OTC DRUG
Nonproprietary name PRAMOXINE HYDROCHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Rida LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-12
Substance PRAMOXINE HYDROCHLORIDE
Active strength 1 g/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 Terramed Just Think Comfort GynoCare BV Guard Intimate Wash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1247251 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 127 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83004-040-01 83004004001 150 mL in 1 BOTTLE (83004-040-01) 150 ml 2024-12-12 No No Current