FDA.reportPublic FDA data

Ortho Super Mint Fluoride Mouthwash

Manufacturer
SuperMouth, LLC.
Effective date
2025-02-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:49

Label at a glance#

ProductOrtho Super Mint Fluoride Mouthwash
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT
(in each 10 mL)

Sodium Fluoride 0.02%

OTC - PURPOSE SECTION

PURPOSE
Sodium Fluoride …. Anticavity

INDICATIONS & USAGE SECTION

USE

Fluoride mouthwash

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
rinsing is accidentally
swallowed, get medical
help or contact a
Poison Control Center
right away.

Do not use if safety seal
is broken.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

1) Shake well before using.
2) Use daily by dispensing 10 mL, swish
    vigorously for 1 minute, and then spit out.
3) No need to rinse.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Water, Erythritol, Xylitol, *Hydroxamin®
(Nano-Hydroxyapatite, Menaquinone-7
(Vit K2), Cholecalciferol (Vit D3)), Inulin,
Glycerin, Sodium Gluconate, Natural
Flavors, Sodium Bicarbonate, Methyl
-sulfonylmethane, Natural Benzoic Acid,
Sodium Ascorbate (Vit C), Xanthan Gum.

Product Labeling: Ortho Super Mint Fluoride Mouthwash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Supermouth

super mint

fluoride mouthwash

unique formulation for orthodontics that
reaches areas brushing & flossing don’t

16 fl oz (473 mL)

SuperMouth®
9737 Aero Drive
San Diego, CA 92123

(844) MOUTHCARE

ortho suber mint 110ortho suber mint 110

res

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
83729-110-16Ortho Super Mint Fluoride Mouthwash473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83729-110ORTHO SUPER MINT FLUORIDE MOUTHWASH (ANTICAVITY MOUTHWASH) LIQUID [SUPERMOUTH, LLC.]11 package rows20250225_e50c3723-4af3-4e5e-a194-5a8a5ebe5d01.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83729-11083729-110-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
ERYTHRITOLRA96B954X6IACT
XYLITOLVCQ006KQ1EIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MENAQUINONE 78427BML8NYIACT
CHOLECALCIFEROL1C6V77QF41IACT
INULINJOS53KRJ01IACT
GLYCERINPDC6A3C0OXIACT
SODIUM GLUCONATER6Q3791S76IACT
SODIUM BICARBONATE8MDF5V39QOIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM ASCORBATES033EH8359IACT
XANTHAN GUMTTV12P4NEEIACT

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
07e8e2fd-6bf0-4cbc-8fcf-f3d4ce5329cae50c3723-4af3-4e5e-a194-5a8a5ebe5d012025-02-23WarningsExact identifier
spl id: 07e8e2fd-6bf0-4cbc-8fcf-f3d4ce5329ca
spl set id: e50c3723-4af3-4e5e-a194-5a8a5ebe5d01

Reported adverse events (FAERS/openFDA)#

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