Home NDC 78151-100 KarlnHans Fresh Breath Double Mint
Product NDC 78151-100
11-digit product format 781510100
Labeler code 78151
Product ID 78151-100_3848713c-8281-a4f0-e063-6394a90a8b88
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route TOPICAL
Labeler PIGEON CORPORATION
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-01
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .74 g/100g
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 KarlnHans Fresh Breath Double Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .74 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737795 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 78151-100-01 KarlnHans Fresh Breath Double Mint 120 g in 1 TUBE PASTE, DENTIFRICE 120 1 78151-100-02 KarlnHans Fresh Breath Double Mint 1 in 1 CARTON PASTE, DENTIFRICE 1 1
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 39 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 Sample Exclude flag Status 78151-100-01 78151010001 120 g in 1 TUBE 120 g Historical 78151-100-02 78151010002 1 TUBE in 1 CARTON (78151-100-02) / 120 g in 1 TUBE (78151-100-01) 1 tube 2025-06-01 No No Current