FDA.reportPublic FDA data

Super Chocolate Prescription

Manufacturer
SuperMouth, LLC.
Effective date
2025-11-12
Label type
Human Prescription Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 22:05:15

Label at a glance#

ProductSuper Chocolate Prescription
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT
Sodium Fluoride 1.1% (5000 ppm)

SPL UNCLASSIFIED SECTION

PURPOSE
Sodium Fluoride …. Anticavity

INACTIVE INGREDIENT SECTION

USE: This medication is used as part of a professional program for the prevention and control of dental caries. Use as directed by your health professional.

WARNINGS AND PRECAUTIONS SECTION

WARNINGS: Do not swallow. Do not use in children under 6 years of age unless recommended by a dentist or physician. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Use as directed by a dentist or physician.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Glycerin, Water, Hydrated Silica, *Hydroxamin® (Nano-Hydroxyapatite, Menquinone-y (Vit K2), Cholecalciferol (Vit D3)), Xylitol, Inulin, Sodium Gluconate, Methylsulfonylmethane, Xanthan Gum, Quillaja Saponaria Extract, Natural Flavor, Natural Benzoic Acid, Sodium Ascorbate (Vit C), Stevia Leaf Extract, Cranberry Seed Oil.
*Patent-Pending Formulation

PRINCIPAL DISPLAY PANEL - SuperMouth Super Chocolate Prescription Toothpaste

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Supermouth Pro

1.1% sodium fluoride

5000 ppm

Anticavity Toothpaste

Rx Only

super chocolate

content: 1 tube 3.4oz (96g)

Dist by: SuperMouth®
9737 Aero Drive
San Diego, CA
844-MOUTHCARE
Made In The USA with
Domestic & global materials

Chocolate BoxChocolate Box

Chocolate TubeChocolate Tube

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
392038sodium fluoride 1.1 % ToothpastePSN3
392038sodium fluoride 0.011 MG/MG ToothpasteSCD3
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY3
392038sodium fluoride 1.1 % Dental GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83729-103-10Super Chocolate Prescription96 g in 1 TUBEPASTE, DENTIFRICE963
83729-103-10Super Chocolate Prescription1 in 1 CARTONPASTE, DENTIFRICE13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83729-10383729-103-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MENAQUINONE 78427BML8NYIACT
CHOLECALCIFEROL1C6V77QF41IACT
XYLITOLVCQ006KQ1EIACT
INULINJOS53KRJ01IACT
SODIUM GLUCONATER6Q3791S76IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
XANTHAN GUMTTV12P4NEEIACT
QUILLAJA SAPONARIA WHOLEHIU9R169Y7IACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM ASCORBATES033EH8359IACT
STEVIA LEAF6TC6NN0876IACT
CRANBERRY SEED OIL73KDS3BW5EIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-30full-release2026-05-31 21:18:28

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Super Chocolate PrescriptionANTICAVITY TOOTHPASTESuperMouth, LLC.bbaccbe4-82ac-4c51-8fc4-a96bf86dfef22025-11-12WarningsExact identifier
ndc (package): 83729-103-10
ndc (product): 83729-103
ndc11 (package): 83729010310
spl id: 51ea5ff4-66da-4d00-b228-d62136d660fe
spl set id: bbaccbe4-82ac-4c51-8fc4-a96bf86dfef2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.