Home NDC 63615-001 Cavity Protection Fresh Mint Anticavity Mouthwash
Product NDC 63615-001
11-digit product format 636150001
Labeler code 63615
Product ID 63615-001_3e78cdb8-cfb4-903c-e063-6294a90add84
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form MOUTHWASH
Route ORAL
Labeler Oxyfresh Worldwide Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-23
Substance SODIUM FLUORIDE
Active strength .5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Cavity Protection Fresh Mint Anticavity Mouthwash
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .5 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 240698 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63615-001-01 Cavity Protection Fresh Mint Anticavity Mouthwash 473 mL in 1 BOTTLE, PLASTIC MOUTHWASH 473 4 63615-001-02 Cavity Protection Fresh Mint Anticavity Mouthwash 3800 mL in 1 JUG MOUTHWASH 3800 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63615-001 CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) MOUTHWASH [OXYFRESH WORLDWIDE INC] 3 Current NDC, Legacy NDC, 2 package rows 20231026_3efc66b2-fcf9-4d26-9cdd-1af8225312b4.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 6 of 50 · 995 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 63615-001-01 63615000101 473 mL in 1 BOTTLE, PLASTIC (63615-001-01) 473 ml 2014-05-23 0000-00-00 No No Current 63615-001-02 63615000102 3800 mL in 1 JUG (63615-001-02) 3800 ml 2014-05-23 0000-00-00 No No Current