denticalm

Generic: topical analgesic

Labeler: nfuse llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name denticalm
Generic Name topical analgesic
Labeler nfuse llc
Dosage Form EMULSION
Routes
TOPICAL
Active Ingredients

menthol 2 g/mL

Manufacturer
NFUSE LLC

Identifiers & Regulatory

Product NDC 82765-0002
Product ID 82765-0002_414fc815-5882-86b6-e063-6294a90ad818
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 827650002
Hyphenated Format 82765-0002

Supplemental Identifiers

RxCUI
1146695
UNII
L7T10EIP3A

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name denticalm (source: ndc)
Generic Name topical analgesic (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/mL
source: ndc
Packaging
  • 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1)
source: ndc

Packages (1)

82765-0002-0 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1)

Ingredients (1)

menthol (2 g/mL)

Linked Drug Pages (1)

DentiCalm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "414fc815-5882-86b6-e063-6294a90ad818", "openfda": {"unii": ["L7T10EIP3A"], "rxcui": ["1146695"], "spl_set_id": ["414e6f6f-06bb-b470-e063-6294a90af390"], "manufacturer_name": ["NFUSE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 PACKAGE (82765-0002-0)  / .47 mL in 1 APPLICATOR (82765-0002-1)", "package_ndc": "82765-0002-0", "marketing_start_date": "20240201"}], "brand_name": "DentiCalm", "product_id": "82765-0002_414fc815-5882-86b6-e063-6294a90ad818", "dosage_form": "EMULSION", "product_ndc": "82765-0002", "generic_name": "Topical Analgesic", "labeler_name": "NFUSE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DentiCalm", "active_ingredients": [{"name": "MENTHOL", "strength": "2 g/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}