anticavity fluoride rinse

Generic: sodium fluoride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name anticavity fluoride rinse
Generic Name sodium fluoride
Labeler topco associates llc
Dosage Form MOUTHWASH
Routes
ORAL
Active Ingredients

sodium fluoride .2 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-838
Product ID 76162-838_4ab9cdfd-2e94-8a3c-e063-6394a90ac07a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2027-12-31
Marketing Start 2024-09-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162838
Hyphenated Format 76162-838

Supplemental Identifiers

RxCUI
240698
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 anticavity fluoride rinse (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 296 mL in 1 BOTTLE, PLASTIC (76162-838-38)
source: ndc

Packages (1)

76162-838-38 296 mL in 1 BOTTLE, PLASTIC (76162-838-38)

Ingredients (1)

sodium fluoride (.2 mg/mL)

Linked Drug Pages (1)

Anticavity fluoride rinse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ab9cdfd-2e94-8a3c-e063-6394a90ac07a", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["240698"], "spl_set_id": ["c3f2e952-a8d5-4e9d-a5c6-09e4f2544179"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "296 mL in 1 BOTTLE, PLASTIC (76162-838-38)", "package_ndc": "76162-838-38", "marketing_start_date": "20240906"}], "brand_name": "Anticavity fluoride rinse", "product_id": "76162-838_4ab9cdfd-2e94-8a3c-e063-6394a90ac07a", "dosage_form": "MOUTHWASH", "product_ndc": "76162-838", "generic_name": "Sodium fluoride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anticavity fluoride rinse", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".2 mg/mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240906", "listing_expiration_date": "20271231"}