Home NDC 37808-616 Calamine, Pramoxind HCl
Product NDC 37808-616
11-digit product format 378080616
Labeler code 37808
Product ID 37808-616_544fe61e-3dd0-605b-e063-6294a90a5d77
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxind HCl
Dosage form LOTION
Route TOPICAL
Labeler H E B
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-15
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
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 Calamine, Pramoxind HCl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 80 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 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 1234532 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 53 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 37808-616-30 37808061630 177 mL in 1 BOTTLE, PLASTIC (37808-616-30) 177 ml 2026-06-15 No No Current