FDA.reportPublic FDA data

DentiCalm

Manufacturer
NFUSE LLC
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:39:19

Label at a glance#

ProductDentiCalm
Active ingredientMENTHOL
Label structure10 sections

Dosage and administration

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2% Purpose: Topical Analgesic

Usage

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)

Warnings

WARNINGS SECTION

For External Use Only
When using this product:
[bullet] Avoid contact with eyes and mucous membranes
[bullet] Do not apply to wounds or broken skin
[bullet] Do not bandage
[bullet] Do not apply to irritated skin or if excessive skin irritation develops
Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

INSTRUCTIONS FOR USE SECTION

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Magnesium Chloride USP, Propanediol, PEG-40 Hydrogenated Castor Oil, L-Theanine, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Boswellia Serrata Oil, Arctium Lappa Root Extract, Thymus Mastichina Flower Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

Purpose

OTC - PURPOSE SECTION

Purpose: Topical Analgesic

Dosage & Admnistration

DOSAGE & ADMINISTRATION SECTION

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

Outer Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackagingOuter Packaging

NDC 82765-0002-0

Inner Primary Container Label Front and Back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 82765-0002-1

Inner Primary Container front and backInner Primary Container front and back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1146695menthol 2 % Topical SolutionPSN2
1146695menthol 20 MG/ML Topical SolutionSCD2
1146695menthol 2 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82765-0002-0DentiCalm1 in 1 PACKAGEEMULSION12
82765-0002-1DentiCalm0.47 mL in 1 APPLICATOREMULSION0.472

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82765-000282765-0002-1, 82765-0002-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
PROPANEDIOL5965N8W85TIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
THEANINE8021PR16QOIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
ALOE VERA LEAFZY81Z83H0XIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
ARCTIUM LAPPA ROOT OIL55DGS3F5YGIACT
THYMUS MASTICHINA FLOWERING TOP OIL9NP0832457IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DentiCalmTOPICAL ANALGESICNFUSE LLC414e6f6f-06bb-b470-e063-6294a90af3902025-10-16WarningsExact identifier
ndc (package): 82765-0002-0
ndc (package): 82765-0002-1
ndc (product): 82765-0002
ndc11 (package): 82765000201
ndc11 (package): 82765000200
spl id: 414fc815-5882-86b6-e063-6294a90ad818
spl set id: 414e6f6f-06bb-b470-e063-6294a90af390

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.