Drugplain

DentiCalm 2 g/mL

Topical Analgesic · EMULSION · NFUSE LLC

No Recall History
Plain English

DentiCalm is a emulsion containing topical analgesic at 2 g/mL, taken topical. Manufactured by NFUSE LLC.

Key Facts

Brand Name
DentiCalm
Generic Name
Topical Analgesic
NDC Code (Product)
82765-0002
Manufacturer
NFUSE LLC
Strength
2 g/mL
Dosage Form
EMULSION
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
02/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

retinal pigment epithelial tear3 reports
chemical burn of skin1 reports
myocardial infarction1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Dosage & Admnistration 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.

Warnings

Warnings 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.

Frequently Asked Questions

What is DentiCalm used for?

DentiCalm contains Topical Analgesic. It is a emulsion taken topical. Consult your doctor for specific uses.

Is DentiCalm a controlled substance?

DentiCalm is not classified as a controlled substance by the DEA.

What is the generic name for DentiCalm?

The generic name for DentiCalm is Topical Analgesic. There are 1 other brand versions of Topical Analgesic.

What is the NDC code for DentiCalm 2 g/mL?

The NDC (National Drug Code) for DentiCalm 2 g/mL is 82765-0002, listed by NFUSE LLC.

Product NDC

82765-0002

Package NDC

82765-0002-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)