FDA.reportPublic FDA data

HEB Gleaming White

Manufacturer
HEB | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
monthly-update
Hydrated at
2026-06-03 17:52:01

Label at a glance#

ProductHEB Gleaming White Arctic Mint
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Storage and handling

Other information Store in a cool, dry place. · Keep tube capped when not in use.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Usesaids in the prevention of dental cavities

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per 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.

STORAGE AND HANDLING SECTION

Other information Store in a cool, dry place. · Keep tube capped when not in use.

INACTIVE INGREDIENT SECTION

Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, mica, titanium dioxide, blue 1

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEB®

GLEAMING WHITE

FLUORIDE ANTICAVITY TOOTHPASTE

Arctic Cool Mint

NET WT. 4.8 OZ (136 g)

HEB GLEAMING WHITE ARCTIC 2821264HEB GLEAMING WHITE ARCTIC 2821264

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN14
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD14
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY14
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY14
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY14
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-320-59HEB Gleaming WhiteArctic Mint1 in 1 BOXPASTE, DENTIFRICE114
37808-320-59HEB Gleaming WhiteArctic Mint136 g in 1 TUBEPASTE, DENTIFRICE13614

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-32037808-320-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)K6MOM3T5YLIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
MICAV8A1AW0880IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132025-08-08full-release2026-06-01 01:09:57

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
HEB Gleaming White Arctic MintSODIUM FLUORIDEHEB8248eddb-20a5-7084-e053-2991aa0a16b52026-01-08WarningsExact identifier
ndc (package): 37808-320-59
ndc (product): 37808-320
ndc11 (package): 37808032059
spl id: 47e53327-6d9c-a9c9-e063-6294a90ad40b
spl set id: 8248eddb-20a5-7084-e053-2991aa0a16b5

Reported adverse events (FAERS/openFDA)#

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