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
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.74 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737795Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1233fc3-047c-4e26-bb2b-8ebde09c05a9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78151-040-01Karl and Hans Botanic Double Mint120 g in 1 TUBEPASTE, DENTIFRICE1202
78151-040-02Karl and Hans Botanic Double Mint1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78151-040KARL AND HANS BOTANIC DOUBLE MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PIGEON CORPORATION]2Current NDC, 2 package rows20240809_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 20 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATETom's of Maineae6de376-76fd-4609-a2d5-7a902c0d4c5c2026-01-27WarningsExact identifier
application number: M021
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
application number: M021
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
application number: M021
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
application number: M021
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact identifier
application number: M021
Colgate Cavity Protection Great Regular FlavorANTICAVITY FLUORIDE TOOTHPASTEColgate-Palmolive Company202c6c62-e16a-4716-babe-d5414006c79e2026-01-21WarningsExact identifier
application number: M021
Crest 3D White Luxe Diamond StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc1420129-5460-4900-ac9a-356d2d7c60a22026-01-21WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsExact identifier
application number: M021
Colgate Total Gum Protect WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companydcf81dcb-b26b-4411-82d4-5f7e9d3fc0f32026-01-20WarningsExact identifier
application number: M021
GuruNanda Anti-CavitySODIUM FLUORIDEGURUNANDA, LLC3b07b72f-4efc-eb0f-e063-6294a90a70a82026-01-19WarningsExact identifier
application number: M021
GuruNanda AnticavitySODIUM FLUORIDEGURUNANDA, LLC3e90d516-3172-3c8d-e063-6294a90a394f2026-01-19WarningsExact identifier
application number: M021
HismilePEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0eba92d1-cbdc-9c96-e063-6294a90a9afc2026-01-15WarningsExact identifier
application number: M021
HismileCOCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3cfb6-6bae-1682-e063-6394a90aca882026-01-15WarningsExact identifier
application number: M021
HismileMANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef3f4f8-fdc4-2056-e063-6394a90a6fd72026-01-15WarningsExact identifier
application number: M021
HismileSMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef41051-dfa0-b105-e063-6294a90a551f2026-01-15WarningsExact identifier
application number: M021
HismileWATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef43107-58ec-d4ee-e063-6294a90ad8d72026-01-15WarningsExact identifier
application number: M021
HismileRED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef56539-dc21-c6ea-e063-6394a90a57902026-01-15WarningsExact identifier
application number: M021
HismileGRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd0ef6f8b5-8565-b364-e063-6294a90aabbc2026-01-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737795sodium monofluorophosphate 0.74 % ToothpastePSNd1233fc3-047c-4e26-bb2b-8ebde09c05a92
1737795sodium monofluorophosphate 0.0074 MG/MG ToothpasteSCDd1233fc3-047c-4e26-bb2b-8ebde09c05a92
1737795sodium monofluorophosphate 0.74 % ToothpasteSYd1233fc3-047c-4e26-bb2b-8ebde09c05a92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78151-040-0178151004001120 g in 1 TUBE120 gHistorical
78151-040-02781510040021 TUBE in 1 CARTON (78151-040-02) / 120 g in 1 TUBE (78151-040-01) 1 tube2024-07-01NoNoCurrent