biotene gentle mint

Generic: sodium fluoride

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name biotene gentle mint
Generic Name sodium fluoride
Labeler haleon us holdings llc
Dosage Form PASTE
Routes
ORAL
Active Ingredients

sodium fluoride 1.5 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0558
Product ID 0135-0558_95462fd1-5eb4-46ff-bf63-a5e610337bc6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2013-07-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350558
Hyphenated Format 0135-0558

Supplemental Identifiers

RxCUI
416783 1044547
UNII
8ZYQ1474W7

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 biotene gentle mint (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-0558-01) / 121.9 g in 1 TUBE
source: ndc

Packages (1)

0135-0558-01 1 TUBE in 1 CARTON (0135-0558-01) / 121.9 g in 1 TUBE

Ingredients (1)

sodium fluoride (1.5 mg/g)

Linked Drug Pages (1)

BIOTENE Fresh Mint Original, BIOTENE Gentle Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "95462fd1-5eb4-46ff-bf63-a5e610337bc6", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783", "1044547"], "spl_set_id": ["1101c17f-c848-4cd5-a7cd-679b59dbe1bf"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-0558-01)  / 121.9 g in 1 TUBE", "package_ndc": "0135-0558-01", "marketing_start_date": "20130715"}], "brand_name": "BIOTENE Gentle Mint", "product_id": "0135-0558_95462fd1-5eb4-46ff-bf63-a5e610337bc6", "dosage_form": "PASTE", "product_ndc": "0135-0558", "generic_name": "sodium fluoride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BIOTENE", "brand_name_suffix": "Gentle Mint", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.5 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130715", "listing_expiration_date": "20261231"}