Home NDC 61554-306 ClaraVie
Product NDC 61554-306
11-digit product format 615540306
Labeler code 61554
Product ID 61554-306_596c467f-a057-ea78-e063-6394a90a79f2
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Gentell LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-19
Substance ZINC OXIDE; MENTHOL
Active strength 20.625; .44 g/100g; g/100g
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 ClaraVie
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20.625 g/100g MENTHOL .44 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2123045 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 49 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61554-306-11 61554030611 113 g in 1 TUBE (61554-306-11) 113 g 2026-08-19 No No Current 61554-306-21 61554030621 5 g in 1 PACKET (61554-306-21) 5 g 2026-08-19 No No Current