FDA.reportPublic FDA data

Simple Truth

Manufacturer
Kroger Company | Lornamead, Inc. | Lornamead Products
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:23:39

Label at a glance#

ProductSimple Truth Kids Flouride
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Storage and handling

Other information Store in a cool dry place. Keep tube covered when not in use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use

Helps protect against cavities

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

​Children under 2 years of age: consult a dentist or physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients Glycerin, Water, Calcium Carbonate, Hydrated Silica, Natural Flavor, Carrageenan, Sodium Lauroyl Sarcosinate

STORAGE AND HANDLING SECTION

Other information

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube R2Tube R2simple truth

KIDS' Fluoride Toothpaste

PREVENTS CAVITIES

STRAWBERRY

no artificial colors, preservatives, flavors or sweeteners

4.2 OZ (119g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN13
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD13
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY13
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY13
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY13
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-146-79Simple TruthKids Flouride119 g in 1 TUBEPASTE, DENTIFRICE11913

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-14630142-146-79

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARRAGEENAN5C69YCD2YJIACT
CALCIUM CARBONATEH0G9379FGKIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML · Source PDF

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
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
ndc (package): 30142-146-79
ndc (product): 30142-146
ndc11 (package): 30142014679
spl id: 45ffc5e9-f379-d523-e063-6394a90a5853
spl set id: 82b9db89-d108-3f64-e053-2991aa0aee74

Reported adverse events (FAERS/openFDA)#

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