FDA.reportPublic FDA data

Crest

Manufacturer
Procter & Gamble Manufacturing México, S. de R.L. de C.V.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:37

Label at a glance#

ProductCrest Bubblegum
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

twist off cap to remove foil seal 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% (0.15% 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.

OTC - WHEN USING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • twist off cap to remove foil seal
  • 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

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, red 28

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

MADE IN MEXICO
DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 119 g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3+ YRS

CREST ANTICAVITY TOOTHPASTE

DISNEY PRINCESS

BUBBLEGUM

NET WT 4.2 OZ (119 g)

artworkartwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN5
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD5
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY5
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY5
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY5
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix91845390Disney Bubblegum.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-047-42CrestBubblegum119 g in 1 TUBEPASTE, DENTIFRICE1195

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58933-04758933-047-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PHOSPHATESE337SVY37IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
D&C RED NO. 28767IP0Y5NHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-13full-release2026-06-01 01:10:17

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
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f618d7-be07-18c3-e063-6294a90a2d972026-01-08WarningsExact identifier
ndc (package): 58933-047-42
ndc (product): 58933-047
ndc11 (package): 58933004742
spl id: 47e559b3-faa8-bd6b-e063-6294a90aa77a
spl set id: 01f618d7-be07-18c3-e063-6294a90a2d97

Reported adverse events (FAERS/openFDA)#

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