Home NDC 78151-040 Karl and Hans Botanic Double Mint
Product NDC 78151-040
11-digit product format 781510040
Labeler code 78151
Product ID 78151-040_1f29a950-cf6b-1e8f-e063-6394a90ac921
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 2024-07-01
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 Karl and Hans Botanic 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 78151-040-01 Karl and Hans Botanic Double Mint 120 g in 1 TUBE PASTE, DENTIFRICE 120 2 78151-040-02 Karl and Hans Botanic Double Mint 1 in 1 CARTON PASTE, DENTIFRICE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78151-040 KARL AND HANS BOTANIC DOUBLE MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PIGEON CORPORATION] 2 Current NDC, 2 package rows 20240809_d1233fc3-047c-4e26-bb2b-8ebde09c05a9.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 33 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 78151-040-01 78151004001 120 g in 1 TUBE 120 g Historical 78151-040-02 78151004002 1 TUBE in 1 CARTON (78151-040-02) / 120 g in 1 TUBE (78151-040-01) 1 tube 2024-07-01 No No Current