mouth rinse

Generic: sodium fluoride

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

Drug Facts

Product Profile

Brand Name mouth rinse
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 36800-001
Product ID 36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2027-12-31
Marketing Start 2010-12-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800001
Hyphenated Format 36800-001

Supplemental Identifiers

RxCUI
1038904
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 mouth rinse (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1000 mL in 1 BOTTLE, PLASTIC (36800-001-86)
source: ndc

Packages (1)

36800-001-86 1000 mL in 1 BOTTLE, PLASTIC (36800-001-86)

Ingredients (1)

sodium fluoride (.1 mg/mL)

Linked Drug Pages (1)

Mouth Rinse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ab7fbe5-4281-9c7d-e063-6394a90a2392", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["1038904"], "spl_set_id": ["c640adc0-e178-4b6a-af44-07d2f7da81d3"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 mL in 1 BOTTLE, PLASTIC (36800-001-86)", "package_ndc": "36800-001-86", "marketing_start_date": "20101230"}], "brand_name": "Mouth Rinse", "product_id": "36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392", "dosage_form": "MOUTHWASH", "product_ndc": "36800-001", "generic_name": "sodium fluoride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mouth Rinse", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".1 mg/mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20101230", "listing_expiration_date": "20271231"}