Home NDC 36800-001 Mouth Rinse
Product NDC 36800-001
11-digit product format 368000001
Labeler code 36800
Product ID 36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Topco Associates LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-12-30
Substance SODIUM FLUORIDE
Active strength .1 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mouth Rinse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038904 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-001-86 Mouth Rinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-001 MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC] 15 Current NDC, Legacy NDC, 1 package rows 20250323_c640adc0-e178-4b6a-af44-07d2f7da81d3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 43 of 49 · 974 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-001-86 36800000186 1000 mL in 1 BOTTLE, PLASTIC (36800-001-86) 1000 ml 2010-12-30 0000-00-00 No No Current