Home NDC 83004-044 Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION
Product NDC 83004-044
11-digit product format 830040044
Labeler code 83004
Product ID 83004-044_54eb672b-d173-8cf6-e063-6394a90a436e
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL,PRAMOXINE HYDROCHLORIDE
Dosage form OINTMENT
Route TOPICAL
Labeler Rida LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-12
Substance MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength 1; 10 mg/g; mg/g
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 HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1 mg/g PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 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 2745581 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 48 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 83004-044-01 83004004401 1 TUBE in 1 CARTON (83004-044-01) / 56 g in 1 TUBE 1 tube 2024-12-12 No No Current