MedPath

365 Everyday Value

5820004 365 Everyday Value Kids Fluoride Toothpaste Strawberry

Approved
Approval ID

836f2df8-00b6-ff2d-e053-2991aa0a8958

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Whole Foods Market, Inc.

DUNS: 196175616

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Monofluorophosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42681-5276
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Monofluorophosphate
Product Specifications
Route of AdministrationDENTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAUROYL SARCOSINATEInactive
Code: 632GS99618
Classification: IACT
SODIUM MONOFLUOROPHOSPHATEActive
Quantity: 0.13 g in 100 g
Code: C810JCZ56Q
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/6/2019

Principal Display Panel

Carton R1

kid's fluoride toothpaste

strawberry

PROTECTS AGAINST CAVITIES

HELPS FIGHT TARTAR

MADE WITHOUT DYES

MADE WITHOUT SODIUM LAURYL OR LAURETH SULFATE

NET WT 4.2 OZ (119g)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/6/2019

Use

aids in the prevention of dental cavities

WARNINGS SECTION

LOINC: 34071-1Updated: 3/6/2019

Warning

**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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/6/2019

DISTRIBUTED BY:

WHOLE FOODS MARKET

AUSTIN, TX 78703

www.wholefoods.com

PRODUCT OF USA

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/6/2019

Active ingredient

Sodium monofluorophosphate 0.76%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/6/2019

Purpose

Anticavity

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/6/2019

Directions

**Adults and children 2 years of age and older:**brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
  • Supervise children as necessary until capable of using without supervision *Children under 2 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/6/2019

Inactive ingredientsglycerin, water, calcium carbonate, hydrated silica, carrageenan, sodium sauroyl sarcosinate, natural flavors.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/6/2019

Other information

Store in a cool dry place. Keep tube capped when not in use.

Tamper evident, use only if seal is intact.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/6/2019

Questions or comments?

  • customer.questions@wholefoods.com
  • 1 (844) 936-8255

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365 Everyday Value - FDA Drug Approval Details