FDA.reportPublic FDA data

Spry Dentifrice

Manufacturer
Xlear Inc.
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:30

Label at a glance#

ProductSpry Dentifrice
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warning: keep out of reach of children under 6 years of age.

WARNINGS AND PRECAUTIONS SECTION

Warnings: If more than used for brushing is accidentaly swallowed, get medical help or contact poison control center right away.

OTC - STOP USE SECTION

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

INDICATIONS & USAGE SECTION

Directions: Adults and children two years and older:

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

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

WARNINGS SECTION

Warnings: 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 poison control center right away

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (w/w)

Anticavity toothpaste

OTC - PURPOSE SECTION

Aids in the prevention of dental cavities

Anticavity Toothpaste

DOSAGE & ADMINISTRATION SECTION

Directions: adults and children two years and older:

brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

INACTIVE INGREDIENT SECTION

Water, silica, vegetable glycerin, xylitol, erythritol, lauryl glucoside, L-arginine, sodium methyl cocoyl taurate, natural speramint flavor, cranberry extract, xanthan gum, titanium dioxide, stevia, cellulose gum, sodium trimetaphosphate, sodium benzoate, zinc citrate, aloe vera

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

display cartondisplay carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27017-142-01Spry Dentifrice1 g in 1 TUBEPASTE, DENTIFRICE11

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
27017-14227017-142-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC CITRATEK72I3DEX9BIACT
ALOE VERA LEAFZY81Z83H0XIACT
CELLULOSE GUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
STEVIA LEAF6TC6NN0876IACT
ERYTHRITOLRA96B954X6IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
N2-(4-FLUOROBENZOYL)-L-ARGININENN7Q1D14KAIACT
SPEARMINT OILC3M81465G5IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
XANTHAN GUMTTV12P4NEEIACT
SODIUM TRIMETAPHOSPHATE3IH6169RL0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
CRANBERRY0MVO31Q3QSIACT

Source Document#

Source XML

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
Spry DentifriceTOOTHPASTEXlear Inc.43567bbc-b07e-b605-e063-6294a90aad782025-11-11WarningsExact identifier
ndc (package): 27017-142-01
ndc (product): 27017-142
ndc11 (package): 27017014201
spl id: 43567bbc-b07f-b605-e063-6294a90aad78
spl set id: 43567bbc-b07e-b605-e063-6294a90aad78

Reported adverse events (FAERS/openFDA)#

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