Home NDC 82765-0002 DentiCalm
Product NDC 82765-0002
11-digit product format 827650002
Labeler code 82765
Product ID 82765-0002_414fc815-5882-86b6-e063-6294a90ad818
Type HUMAN OTC DRUG
Nonproprietary name Topical Analgesic
Dosage form EMULSION
Route TOPICAL
Labeler NFUSE LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance MENTHOL
Active strength 2 g/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 DentiCalm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1146695 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82765-0002-0 DentiCalm 1 in 1 PACKAGE EMULSION 1 2 82765-0002-1 DentiCalm 0.47 mL in 1 APPLICATOR EMULSION 0.47 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82765-0002-0 82765000200 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1) 1 applicator 2024-02-01 No No Current 82765-0002-1 82765000201 0.47 mL in 1 APPLICATOR 0.47 ml Historical