FDA.reportPublic FDA data

Super Strawberry

Manufacturer
SuperMouth, LLC.
Effective date
2025-07-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:35

Label at a glance#

ProductSuper Strawberry
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

ACTIVE INGREDIENT

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

PURPOSE
Anticavity Toothpaste

INDICATIONS & USAGE SECTION

USE

Aids in the prevention of cavities

WARNINGS SECTION

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

OTHER SAFETY INFORMATION

If more than used for brushing is accidentally swallowed, get medical help or
contact a Poison Control Center right away.

ALWAYS FOLLOW LABEL

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • Children under 3 yrs: use no more than a tiny grain-of-rice smear.
  • Children between 3 and 6: use only a pea sized amount.

  • Place product on SuperMouth® toothbrush and brush teeth thoroughly at least
    twice a day for 2 minutes or use as directed by a Dentist or Physician. Supervise
    child’s brushing and rinsing to minimize swallowing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS Glycerin, Water, Hydrated Silica, *Hydroxamin®
(Nano-Hydroxyapatite, Menaquinone-7 (Vitamin K2), Cholecalciferol (Vitamin D3)),
Xylitol, Inulin, Natural Flavors, Sodium Gluconate, Methylsulfonylmethane, Xanthan
Gum, Quillaja Saponaria Extract, Sodium Methyl Cocoyl Taurate, Natural Benzoic
Acid, Sodium Ascorbate (Vitamin C), Stevia Leaf Extract, Cranberry Seed Oil.

Product Labeling: Super Strawberry Fluoride Toothpaste

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

..........................................................................

Supermouth

super strawberry

fluoride toothpaste

safe • effective • fun

3.4 oz (96 g)

SuperMouth®

9737 Aero Drive,
San Diego, CA 92123
(844) MOUTHCARE

Super strawberry 116Super strawberry 116

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

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
83729-116-10Super Strawberry96 g in 1 TUBEPASTE, DENTIFRICE961
83729-116-10Super Strawberry1 in 1 CARTONPASTE, DENTIFRICE11

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83729-11683729-116-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM ASCORBATES033EH8359IACT
STEVIA LEAF6TC6NN0876IACT
CRANBERRY SEED OIL73KDS3BW5EIACT

Source Document#

Source XML

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 StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
ndc (package): 83729-116-10
ndc (product): 83729-116
ndc11 (package): 83729011610
spl id: 684a0eb8-9507-422e-8f8c-15197f86ce70
spl set id: a8c2b68d-d28b-41c0-a383-cc706b25aa1a

Reported adverse events (FAERS/openFDA)#

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