biotene

Generic: sodium monofluorophosphate

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

Drug Facts

Product Profile

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

sodium monofluorophosphate 1.4 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0577
Product ID 0135-0577_c26f08a5-fa67-417e-8499-015edb65f7f8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2016-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350577
Hyphenated Format 0135-0577

Supplemental Identifiers

RxCUI
545626
UNII
C810JCZ56Q

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 (source: ndc)
Generic Name sodium monofluorophosphate (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0135-0577-01) / 121.9 g in 1 TUBE
source: ndc

Packages (1)

0135-0577-01 1 TUBE in 1 CARTON (0135-0577-01) / 121.9 g in 1 TUBE

Ingredients (1)

sodium monofluorophosphate (1.4 mg/g)

Linked Drug Pages (1)

biotene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c26f08a5-fa67-417e-8499-015edb65f7f8", "openfda": {"unii": ["C810JCZ56Q"], "rxcui": ["545626"], "spl_set_id": ["a47a6502-efb2-4072-9562-cbe293531c2b"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0135-0577-01)  / 121.9 g in 1 TUBE", "package_ndc": "0135-0577-01", "marketing_start_date": "20160901"}], "brand_name": "biotene", "product_id": "0135-0577_c26f08a5-fa67-417e-8499-015edb65f7f8", "dosage_form": "PASTE", "product_ndc": "0135-0577", "generic_name": "sodium monofluorophosphate", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "biotene", "active_ingredients": [{"name": "SODIUM MONOFLUOROPHOSPHATE", "strength": "1.4 mg/g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160901", "listing_expiration_date": "20261231"}