anticavity

Generic: sodium fluoride

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

Drug Facts

Product Profile

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

sodium fluoride .1 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-803
Product ID 36800-803_4ab95103-9408-07c3-e063-6394a90a5921
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 2015-09-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800803
Hyphenated Format 36800-803

Supplemental Identifiers

RxCUI
313029
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 (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 474 mL in 1 BOTTLE, PLASTIC (36800-803-43)
  • 946 mL in 1 BOTTLE, PLASTIC (36800-803-45)
source: ndc

Packages (2)

36800-803-43 474 mL in 1 BOTTLE, PLASTIC (36800-803-43) 36800-803-45 946 mL in 1 BOTTLE, PLASTIC (36800-803-45)

Ingredients (1)

sodium fluoride (.1 mg/mL)

Linked Drug Pages (1)

Anticavity ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ab95103-9408-07c3-e063-6394a90a5921", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["313029"], "spl_set_id": ["c337c982-bd18-4a1a-851a-fca1551a242e"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "474 mL in 1 BOTTLE, PLASTIC (36800-803-43)", "package_ndc": "36800-803-43", "marketing_start_date": "20150915"}, {"sample": false, "description": "946 mL in 1 BOTTLE, PLASTIC (36800-803-45)", "package_ndc": "36800-803-45", "marketing_start_date": "20150915"}], "brand_name": "Anticavity", "product_id": "36800-803_4ab95103-9408-07c3-e063-6394a90a5921", "dosage_form": "MOUTHWASH", "product_ndc": "36800-803", "generic_name": "Sodium fluoride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anticavity", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".1 mg/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150915", "listing_expiration_date": "20271231"}