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 127 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc e1a8d4a7-01f7-4bab-8d09-875c461b3b61 2024-09-19 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Strategic Sourcing Services, LLC 2216d799-7f6f-cab7-e063-6294a90a8d6c 2024-09-14 Warnings Exact identifier application number: M017 Meijer Analgesic Lidocaine Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa 2024-09-12 Warnings Exact identifier application number: M017 leader anti itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Cardinal Health 110, LLC. dba Leader e1aab35b-80d9-4515-afb7-8c662bc5d028 2024-09-11 Warnings Exact identifier application number: M017 LactiGo MENTHOL LactiGo, Inc. 849c3601-2bc8-0991-e053-2a91aa0a5e7f 2024-09-03 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis MENTHOL 8% Telebrands Corp c22cf1a5-0d5d-5ea5-e053-2995a90a333b 2024-09-02 Warnings Exact identifier application number: M017 Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Exact identifier application number: M017 BIOSAVIA External Analgesic Pain Relief CAPSAICIN BIOSAVIA USA, LLC 814aa66b-7719-4a29-a84e-18290367e9c7 2024-08-28 Warnings Exact identifier application number: M017 Careland Plantar Fasciitis Hydrogel Pain Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 0e2f29c2-2e95-4be0-b7e9-f1761a1321a5 2024-08-21 Warnings Exact identifier application number: M017 Careland Max Strength Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 265b8dd7-64a4-4bc2-a91c-26c761c2090b 2024-08-21 Warnings Exact identifier application number: M017 Real Time Pain Relief Maxx Topical Analgesic MENTHOL REAL TIME PRODUCTS, INC f45eb95a-2813-4124-bdb0-54e078a8237d 2024-08-20 Warnings Exact identifier application number: M017 Theracare Lidocaine Pain relief LIDOCAINE Veridian Healthcare 1d8a3679-637d-94c0-e063-6294a90a9ecf 2024-08-19 Warnings Exact identifier application number: M017 LidoSync LIDOCAINE, MENTHOL iON Pharma, LLC 200f883c-439a-3b99-e063-6394a90aed10 2024-08-19 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 09243a23-1f17-f77b-e063-6394a90a0b22 2024-08-19 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Scalp Relief Anti-itch HYDROCORTISONE CVS Health b5ef0005-8b76-4205-8be0-db3a7ed7d1c4 2024-08-19 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving Roll-On LIDOCAINE HCL Rite Aid Corporation 1406590c-667c-84eb-e063-6294a90a5052 2024-08-16 Warnings Exact identifier application number: M017 Nuvira CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10% Strand Health Group ff448183-03cf-df2d-e053-6394a90a77f0 2024-08-16 Warnings Exact identifier application number: M017 FLANAX METHYL SALICYLATE, MENTHOL, CAPSAICIN Belmora LLC 5e06c688-a086-4c1c-8dab-fcead61fef40 2024-08-13 Warnings Exact identifier application number: M017 Pain Relief MENTHOL Pain Relieving Spray Inc. 1f44466f-044f-70fe-e063-6294a90ad575 2024-08-09 Warnings Exact identifier application number: M017
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