FDA.reportPublic FDA data

Gum and Enamel Repair

Manufacturer
CVS | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:51:44

Label at a glance#

ProductGum and Enamel Repair
Active ingredientSTANNOUS FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

OTC - PURPOSE SECTION

Anticavity/antigingivitis

INDICATIONS & USAGE SECTION

aids in the prevention of cavities * helps prevent gingivitis * helps interferre with the harmful effects of plaque associated with gingivisits * helps control plaque bacteria that contribute to the development of gingivitis

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 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

adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician * do not swallow * children under 12 years of age: ask a dentist

OTHER SAFETY INFORMATION

products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing my 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 * see your dentist regularly

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton R1Carton R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN5
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD5
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-645-592024-02-23C16284748780-1f386c64a-0944-0266-e053-dadaa90a7c1a5820054 CVS Gum & Enam Repair
69842-645-592024-02-23C16284748780-1f386c64a-0944-0266-e053-dadaa90a7c1a5820054 CVS Gum & Enam Repair
69842-645-592023-01-30C16284748780-1f386c64a-0944-0266-e053-dadaa90a7c1a5820054 CVS Gum & Enam Repair
69842-645-592023-01-30C16284748780-1f386c64a-0944-0266-e053-dadaa90a7c1a5820054 CVS Gum & Enam Repair

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-645-59Gum and Enamel Repair116.2 g in 1 TUBEPASTE, DENTIFRICE116.25
69842-645-59Gum and Enamel Repair1 in 1 CARTONPASTE, DENTIFRICE15

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-64569842-645-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC CITRATEK72I3DEX9BIACT
STANNOUS FLUORIDE3FTR44B32QACTIM
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM HYDROXIDE55X04QC32IIACT
CARRAGEENAN5C69YCD2YJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-01-17full-release2026-06-01 00:53:07

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
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
ndc (package): 69842-645-59
ndc (product): 69842-645
ndc11 (package): 69842064559
spl id: 47e6024c-0154-bf83-e063-6294a90a94cf
spl set id: ccad05d4-7f05-bebd-e053-2a95a90aa52c

Reported adverse events (FAERS/openFDA)#

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