FDA.reportPublic FDA data

Crest Premium Plus

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
monthly-update
Hydrated at
2026-06-03 17:52:05

Label at a glance#

ProductCrest Premium Plus Sensitivity Active Foam
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact aids in the prevention of cavities

Dosage and administration

do not swallow 12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. do not use in children under 12 yrs.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Potassium nitrate 5%Toothpaste for sensitive teeth
Sodium fluoride 0.243% (0.14% w/v fluoride ion)Toothpaste for cavity prevention

Uses

INDICATIONS & USAGE SECTION

  • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of cavities

Warnings

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product do not use longer than four weeks unless recommended by a dentist.

OTC - STOP USE SECTION

Stop use and ask a dentist if problem lasts or gets worse. Sensitive teeth may indicate a serious problem that may need prompt care.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not swallow
  • 12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not use in children under 12 yrs.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, alcohol (0.7%), sodium saccharin, xanthan gum, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 147 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest® plus

PREMIUM

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 5.2 OZ (147 g)

ACTIVE FOAM

+WHITENING

SENSITIVE

MAXIMUM STRENGTH*

SENSITIVITY RELIEF

soothing mint

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN12
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD12
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY12
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY12
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix90451999Crst Prem Sens.pdf.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-995-522024-01-30C16284748780-11030e365-5f5f-111a-e063-dadaa90a10e2Crest Premium Plus Sensitivity Active Foam + Whitening
37000-995-522024-01-30C16284748780-11030e365-5f5f-111a-e063-dadaa90a10e2Crest Premium Plus Sensitivity Active Foam + Whitening
37000-995-702024-01-30C16284748780-11030e365-5f5f-111a-e063-dadaa90a10e2Crest Premium Plus Sensitivity Active Foam + Whitening
37000-995-702024-01-30C16284748780-11030e365-5f5f-111a-e063-dadaa90a10e2Crest Premium Plus Sensitivity Active Foam + Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-995-52Crest Premium PlusSensitivity Active Foam147 g in 1 TUBEPASTE, DENTIFRICE14712
37000-995-52Crest Premium PlusSensitivity Active Foam1 in 1 CARTONPASTE, DENTIFRICE112
37000-995-70Crest Premium PlusSensitivity Active Foam1 in 1 CARTONPASTE, DENTIFRICE112
37000-995-70Crest Premium PlusSensitivity Active Foam198 g in 1 TUBEPASTE, DENTIFRICE19812

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-99537000-995-70, 37000-995-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
BENZOIC ACID8SKN0B0MIMIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ALCOHOL3K9958V90MIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-12-18full-release2026-06-01 01:26:34

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 Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
ndc (package): 37000-995-52
ndc (package): 37000-995-70
ndc (product): 37000-995
ndc11 (package): 37000099570
ndc11 (package): 37000099552
spl id: 47e4e251-448a-efc5-e063-6294a90a56a8
spl set id: b8535d1c-cf15-f353-e053-2a95a90a7974

Reported adverse events (FAERS/openFDA)#

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