FDA.reportPublic FDA data

OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR

Manufacturer
CVS Pharmacy, Inc.
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:25:16

Label at a glance#

ProductOCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

helps protect against cavities.

Dosage and administration

• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. • Do not swallow. • Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. • Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243%
(Fluoride ion content 1100 ppm)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Do not swallow.
• Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Yellow 5, FD&C Blue 1

SPL UNCLASSIFIED SECTION

Compare to ACT® Kids Anticavity Fluoride Toothpaste*

Strengthens teeth

Helps prevent cavities

CVS Health® Ocean Friends Anticavity Fluoride Toothpaste strengthens growing teeth and helps prevent cavities with a tasty watermelon flavor kids will love.

*This product is not manufactured or distributed by Sanofi, the distributor of ACT® Kids Anticavity Fluoride Toothpaste.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India V-40421

100% money back guaranteed.
CVS.com/returnpolicy

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WATERMELON FLAVORWATERMELON FLAVOR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-162-01OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR130 g in 1 TUBEPASTE, DENTIFRICE1301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-162OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY, INC.]1Current NDC, 1 package rows20241016_4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-16251316-162-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
ndc (package): 51316-162-01
ndc (product): 51316-162
ndc11 (package): 51316016201
spl id: 7a2e7b21-7b68-4ab2-8751-bc5a0f569737
spl set id: 4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef

Reported adverse events (FAERS/openFDA)#

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