Gum and Enamel Repair

Product NDC
69842-645
11-digit product format
698420645
Labeler code
69842
Product ID
69842-645_47e6024c-0154-bf83-e063-6294a90a94cf
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
CVS
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-18
Substance
STANNOUS FLUORIDE
Active strength
.14 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Gum and Enamel Repair
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.14 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ccad05d4-7f05-bebd-e053-2a95a90aa52cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-02-235820054 CVS Gum & Enam Repair
2024-02-235820054 CVS Gum & Enam Repair
2023-01-305820054 CVS Gum & Enam Repair
2023-01-305820054 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-645GUM AND ENAMEL REPAIR (STANNOUS FLUORIDE) PASTE, DENTIFRICE [CVS]4Current NDC, Legacy NDC, 2 package rows20250119_ccad05d4-7f05-bebd-e053-2a95a90aa52c.zip

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 34 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Whipped Mellow Mint Dream FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company7a72b687-475d-437a-9734-a29637e5516a2025-11-11WarningsExact identifier
application number: M021
Spry DentifriceTOOTHPASTEXlear Inc.43567bbc-b07e-b605-e063-6294a90aad782025-11-11WarningsExact identifier
application number: M021
Hello Naturally WhiteningSODIUM MONOFLUOROPHOSPHATECOLGATE PALMOLIVE COMPANY5ad241e1-6bfc-7863-6a7a-100753651f0a2025-11-11WarningsExact identifier
application number: M021
Hello Whipped Peppermint Stick FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyd6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f8132025-11-11WarningsExact identifier
application number: M021
Super MintMINT TOOTHPASTESuperMouth, LLC.d23e89f5-7b65-4ed9-803a-38233f30d8f22025-11-07WarningsExact identifier
application number: M021
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
application number: M021
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
application number: M021
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
application number: M021
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
application number: M021
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
application number: M021
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
application number: M021
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
application number: M021
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
application number: M021
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSNccad05d4-7f05-bebd-e053-2a95a90aa52c5
416784stannous fluoride 0.00454 MG/MG ToothpasteSCDccad05d4-7f05-bebd-e053-2a95a90aa52c5
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSYccad05d4-7f05-bebd-e053-2a95a90aa52c5
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSYccad05d4-7f05-bebd-e053-2a95a90aa52c5
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSYccad05d4-7f05-bebd-e053-2a95a90aa52c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-645-59698420645591 TUBE in 1 CARTON (69842-645-59) / 116.2 g in 1 TUBE1 tube2021-10-180000-00-00NoNoCurrent