hismile

Generic: sodium fluoride

Labeler: hismile pty ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hismile
Generic Name sodium fluoride
Labeler hismile pty ltd
Dosage Form GEL
Routes
DENTAL
Active Ingredients

sodium fluoride .243 g/100g

Manufacturer
HISMILE PTY LTD

Identifiers & Regulatory

Product NDC 83013-326
Product ID 83013-326_4879b7a1-f8f7-92e6-e063-6394a90a41a5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2027-12-31
Marketing Start 2024-07-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83013326
Hyphenated Format 83013-326

Supplemental Identifiers

RxCUI
416783
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 hismile (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .243 g/100g
source: ndc
Packaging
  • 60 g in 1 BOTTLE, PUMP (83013-326-06)
source: ndc

Packages (1)

83013-326-06 60 g in 1 BOTTLE, PUMP (83013-326-06)

Ingredients (1)

sodium fluoride (.243 g/100g)

Linked Drug Pages (1)

HISMILE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "4879b7a1-f8f7-92e6-e063-6394a90a41a5", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["1de591d9-9cab-e63d-e063-6394a90ac8eb"], "manufacturer_name": ["HISMILE PTY LTD"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 g in 1 BOTTLE, PUMP (83013-326-06)", "package_ndc": "83013-326-06", "marketing_start_date": "20240723"}], "brand_name": "HISMILE", "product_id": "83013-326_4879b7a1-f8f7-92e6-e063-6394a90a41a5", "dosage_form": "GEL", "product_ndc": "83013-326", "generic_name": "Sodium Fluoride", "labeler_name": "HISMILE PTY LTD", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HISMILE", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".243 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240723", "listing_expiration_date": "20271231"}