FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
KarlnHans Fresh Breath Double Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.74 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui1737795

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78151-100-01KarlnHans Fresh Breath Double Mint120 g in 1 TUBEPASTE, DENTIFRICE1201
78151-100-02KarlnHans Fresh Breath Double Mint1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737795sodium monofluorophosphate 0.74 % ToothpastePSN38487130-9508-a2c4-e063-6394a90aa3231
1737795sodium monofluorophosphate 0.0074 MG/MG ToothpasteSCD38487130-9508-a2c4-e063-6394a90aa3231
1737795sodium monofluorophosphate 0.74 % ToothpasteSY38487130-9508-a2c4-e063-6394a90aa3231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78151-100-0178151010001120 g in 1 TUBE120 gHistorical
78151-100-02781510100021 TUBE in 1 CARTON (78151-100-02) / 120 g in 1 TUBE (78151-100-01) 1 tube2025-06-01NoNoCurrent