FDA.reportPublic FDA data

H E B

Manufacturer
HEB | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
monthly-update
Hydrated at
2026-06-03 17:51:45

Label at a glance#

ProductH E B Restore and Defend
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity/Antihypersensitivity

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE SECTION

Stop use and ask a dentist if:

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • Do not swallow.
  • Children under 12 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

OTC - QUESTIONS SECTION

Questions or Comments? CALL 1-877-777-2743

SPL UNCLASSIFIED SECTION

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

OTHER SAFETY INFORMATION

Other information products containng stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • this product is specifically formulated to help prevent staining.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB_RESTORE_DEFEND_CTN_2821230R3HEB_RESTORE_DEFEND_CTN_2821230R3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN15
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD15
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY15
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY15
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY15

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041220996506GTIN-13: 0041220996506
EAN-13: 0041220996506
GTIN-12: 041220996506
UPC-A: 041220996506
GTIN storage (14 digits): 00041220996506		HEB_RESTORE_DEFEND_CTN_2821230R3.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-230-09H E BRestore and Defend1 in 1 CARTONPASTE, DENTIFRICE115
37808-230-09H E BRestore and Defend96.4 g in 1 TUBEPASTE, DENTIFRICE96.415
37808-230-92H E BRestore and Defend2 in 1 CARTONPASTE, DENTIFRICE215
37808-230-92H E BRestore and Defend96.4 g in 1 TUBEPASTE, DENTIFRICE96.415

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P91
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM TRIPOLYPHOSPHATE ANHYDROUSINACTIVE INGREDIENT9SW4PFD2FZ1
SORBITOLINACTIVE INGREDIENT506T60A25R1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-23037808-230-09, 37808-230-92

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
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142025-08-08full-release2026-06-01 01:09:47

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE, DENTIFRICE / DENTAL1.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE, DENTIFRICE / DENTAL1.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
H E B Restore and DefendFLUORIDEHEB56080493-9ab8-4b4f-be5f-7df22dee133f2026-01-08WarningsExact identifier
ndc (package): 37808-230-09
ndc (package): 37808-230-92
ndc (product): 37808-230
ndc11 (package): 37808023009
ndc11 (package): 37808023092
spl id: 47e52621-fd2a-850a-e063-6294a90affff
spl set id: 56080493-9ab8-4b4f-be5f-7df22dee133f

Reported adverse events (FAERS/openFDA)#

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