FDA.reportPublic FDA data

Burts Bees

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
monthly-update
Hydrated at
2026-06-03 17:52:04

Label at a glance#

ProductBurts Bees Kids Strawberry Splash
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children’s brushing until good habits are established children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children’s brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, hydrated silica, sodium cocoyl glutamate, flavor*, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-855-248-5352

SPL UNCLASSIFIED SECTION

*Natural Flavor

SPL UNCLASSIFIED SECTION

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 119 g tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

burt's

bees®

KIDS

FLUORIDE

toothpaste

STRARBERRY SPLASH

FIGHTS CAVITIES
Tastes Great
Dye Free

NET WT 4.2 OZ (119 g)

980980

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN10
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD10
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY10
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY10
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY10
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-980-422024-02-06C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-422024-02-06C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-472024-02-06C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-472024-02-06C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-422024-01-30C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-422024-01-30C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-472024-01-30C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash
37000-980-472024-01-30C16284748780-11030e365-6ddc-111a-e063-dadaa90a10e2Burt's Bees Kids Strawberry Splash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-980-18Burts BeesKids Strawberry Splash4 in 1 CELLO PACKPASTE, DENTIFRICE410
37000-980-18Burts BeesKids Strawberry Splash1 in 1 CARTONPASTE, DENTIFRICE110
37000-980-42Burts BeesKids Strawberry Splash119 g in 1 TUBEPASTE, DENTIFRICE11910
37000-980-47Burts BeesKids Strawberry Splash1 in 1 CARTONPASTE, DENTIFRICE110
37000-980-47Burts BeesKids Strawberry Splash133 g in 1 TUBEPASTE, DENTIFRICE13310

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-98037000-980-42, 37000-980-47, 37000-980-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARRAGEENAN5C69YCD2YJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-08-20full-release2026-06-01 01:11:16

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
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Companyb6c180ae-00da-6fab-e053-2a95a90a089e2026-01-08WarningsExact identifier
ndc (package): 37000-980-18
ndc (package): 37000-980-47
ndc (package): 37000-980-42
ndc (product): 37000-980
ndc11 (package): 37000098047
ndc11 (package): 37000098042
ndc11 (package): 37000098018
spl id: 47e33982-79c5-9917-e063-6294a90a7d39
spl set id: b6c180ae-00da-6fab-e053-2a95a90a089e

Reported adverse events (FAERS/openFDA)#

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