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 120 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Muscular Balm CAPSAICIN MENTHOL METHYL SALICYLATE Borden Company (Private) Limited ed79f14e-6b3d-4bf2-9c34-d019c1ba2582 2024-11-04 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE A-S Medication Solutions 3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3 2024-11-04 Warnings Exact identifier application number: M017 Walgreens Ice Blue Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Walgreen Company 1c0ee442-ffd2-4f6c-aab2-f70e295378ad 2024-11-04 Warnings Exact identifier application number: M017 Walgreen Cool n Heat Maximum Strength Pain Relieving MENTHOL, UNSPECIFIED FORM Walgreen Company d5c79476-dde8-4a85-8878-bc2ac3a3d70b 2024-11-04 Warnings Exact identifier application number: M017 LIDOCAINE LIDOCAINE STRATUS PHARMACEUTICALS INC 87a4f559-a4f6-4b9f-98de-b55b073a11c6 2024-11-01 Warnings Exact identifier application number: M017 Walgreens Nerve Pain Relieving Topical Analgesic LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM Walgreen Company 83849eca-e02f-4b43-b3a7-b25e987e08a8 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica White CAMPHOR Sanvall Enterprises, Inc 192039a2-aed6-821b-e063-6394a90a7f29 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica Reforzada CAMPHOR Sanvall Enterprises, Inc 1921a4b1-cd36-195e-e063-6294a90a8793 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Arnica Pain Releiving Roll On with Camphor CAMPHOR Sanvall Enterprises, Inc 173db0e2-611f-55b9-e063-6394a90ac987 2024-10-31 Warnings Exact identifier application number: M017 Sanar Naturals Camphor CAMPHOR Sanvall Enterprises, Inc 1921e851-cf83-0bdb-e063-6294a90a357f 2024-10-31 Warnings Exact identifier application number: M017 cortisone HYDROCORTISONE CVS Pharmacy c766deac-d993-4e48-a5c3-4cfde7338dff 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Lavender Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 6c7b39c8-5b65-430a-a529-5b6b14adce18 2024-10-31 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Plus Turmeric Analgesic TROLAMINE SALICYLATE Walgreen Company f3a121bc-7572-49a4-9822-2b6d858c19d2 2024-10-31 Warnings Exact identifier application number: M017 dg health hydrocortisone HYDROCORTISONE Dolgencorp, LLC 27dc9e09-fc4f-4b66-a303-177725f3a513 2024-10-31 Warnings Exact identifier application number: M017 basic care hydrocortisone HYDROCORTISONE Amazon.com Services LLC f5419859-3f9f-43ff-9a3f-6aa81af044f0 2024-10-31 Warnings Exact identifier application number: M017 ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM STRATUS PHARMACEUTICALS INC d27fbc17-46b7-4d52-ba29-c99b6c63144a 2024-10-31 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE, MENTHOL R & Y Group, LLC fe0478d8-2f06-cd56-e053-6294a90a58e5 2024-10-30 Warnings Exact identifier application number: M017 JOINT-RITIS PAIN RELIEVING ROLL-ON MENTHOL Lifeline Naturals of America, Inc. ec5d99c4-6bba-45d1-84e0-12fb7cb31495 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving with Turmeric Analgesic LIDOCAINE HYDROCHLORIDE Walgreen Company 317ec4fb-cff0-461d-9ca0-299527a3686d 2024-10-30 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Analgesic CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Walgreen Company 3215a676-104c-43c3-aa36-b30d5b67799a 2024-10-30 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