FDA.reportPublic FDA data

Burts Bees

Manufacturer
Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:51:38

Label at a glance#

ProductBurts Bees Extra White Zen Peppermint
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*, cocamidopropyl betaine*, flavor**, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-855-248-5352

SPL UNCLASSIFIED SECTION

*contains one of these ingredients
**Peppermint Oil and other Natural Flavor

SPL UNCLASSIFIED SECTION

DISTR. BY SUNFLOWER DISTRIBUTING
LLC, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 133 g tube in carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURT'S

BEES®

Extra

White

FLUORIDE

Toothpaste

ADA

Accepted

American

Dental

Association

Zen

Peppermint

NET WT 4.7 OZ (133 g)

925925

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN7
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD7
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY7
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY7
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY7
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-925-472023-05-19C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472023-05-19C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472023-01-30C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472023-01-30C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472021-02-12C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472021-02-12C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472021-01-29C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint
37000-925-472021-01-29C16284748780-1ba0f9c33-42de-a910-e053-dadaa90a0b85Burt's Bees® Extra White Zen Peppermint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-925-47Burts BeesExtra White Zen Peppermint1 in 1 CARTONPASTE, DENTIFRICE17
37000-925-47Burts BeesExtra White Zen Peppermint133 g in 1 TUBEPASTE, DENTIFRICE1337

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-92537000-925-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
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
62025-08-06full-release2026-06-01 01:09:41

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 Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
ndc (package): 37000-925-47
ndc (product): 37000-925
ndc11 (package): 37000092547
spl id: 47e4ea72-0686-1933-e063-6294a90ad7e1
spl set id: 81279e1f-6224-8114-e053-2991aa0aab08

Reported adverse events (FAERS/openFDA)#

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