FDA.reportPublic FDA data

Therabreath

Product NDC
10237-271
11-digit product format
102370271
Labeler code
10237
Product ID
10237-271_5cb8aa68-be0c-9332-e063-6294a90a0ee9
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
STANNOUS FLUORIDE
Active strength
.454 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
Therabreath
Brand name suffix
Healthy Gums
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.454 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-271-04TherabreathHealthy Gums1 in 1 CARTONPASTE, DENTIFRICE11
10237-271-04TherabreathHealthy Gums113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-271-07TherabreathHealthy Gums19 g in 1 TUBEPASTE, DENTIFRICE191
10237-271-07TherabreathHealthy Gums1 in 1 CARTONPASTE, DENTIFRICE11
10237-271-24TherabreathHealthy Gums113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-271-24TherabreathHealthy Gums2 in 1 CARTONPASTE, DENTIFRICE21

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 39 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Clinical Solutions Enamel Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC11e1c1d0-465b-9e14-e063-6394a90a8cdd2025-04-22WarningsExact identifier
application number: M021
Hello Mighty Multi taskerSTANNOUS FLUORIDEColgate-Palmolive Company48e36e06-3666-9032-b9c8-4be035e751f22025-04-15WarningsExact identifier
application number: M021
Hello Kids Wild Strawberry Wild StrawberrySODIUM FLUORIDEColgate-Palmolive Company39dddf11-45a0-b883-e12f-d80c582e8c892025-04-15WarningsExact identifier
application number: M021
Hello Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.300303e7-ef8b-7449-e063-6294a90ac8112025-04-09WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.303d4ad0-5a2b-347a-e063-6394a90aa0ba2025-04-07WarningsExact identifier
application number: M021
OralLine KidsSODIUM FLUORIDEJ.M. Murray Center Inc.12c5bee5-e228-4f71-9bfd-c377ee2372a92025-03-21WarningsExact identifier
application number: M021
AdoptaPlatoonSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDc1592b56-cf3d-4a4d-be84-e40eb3f1456e2025-03-21WarningsExact identifier
application number: M021
OralLine SecureSODIUM FLUORIDEJ.M. Murray Center Inc.4c0970e9-7417-4234-89e3-3b602a609af52025-03-20WarningsExact identifier
application number: M021
Crayola ANTICAVITY BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios, Inc.ec66246f-06e2-4da1-b9d5-ce2a7815ffd12025-03-19WarningsExact identifier
application number: M021
smart way MINT cavity protectionSODIUM MONOFLUOROPHOSPHATEThe Kroger Co.45cc7a60-b4a7-4263-a114-f0d1f98a87fc2025-03-19WarningsExact identifier
application number: M021
Crayola ANTICAVITY WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.720f6344-ac48-414c-a1c2-f56c3206343c2025-03-19WarningsExact identifier
application number: M021
Crayola ANTICAVITY STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios, Inc.17bd65a8-0a33-4421-8b9a-a7f9b94fe9872025-03-19WarningsExact identifier
application number: M021
HismileMAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd309366f8-6a52-fe9f-e063-6394a90a5de32025-03-18WarningsExact identifier
application number: M021
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b3e72ca-2bbb-adf1-e063-6394a90a2c7a2025-03-13WarningsExact identifier
application number: M021
Hismile Pink Lemonade Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2b92ff92-3722-3702-e063-6394a90a38b02025-03-13WarningsExact identifier
application number: M021
Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHismile Pty Ltd2ba2318e-7a58-7b68-e063-6394a90ae7842025-03-13WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint Anticavity FluorideSODIUM FLUORIDEKenvue Brands LLCed15e0b9-00c9-0df1-e053-2a95a90a42c02025-02-28WarningsExact identifier
application number: M021
WHITE GLO BIO-ENZYMESODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCf894a841-0df7-470d-8fc2-c9d6ba0edf992025-02-26WarningsExact identifier
application number: M021
WHITE GLO MICELLARSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC16be06ba-330d-46b8-ba4e-5d732642ee262025-02-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY3c3683f0-8047-a648-e063-6394a90a258f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-271-04102370271041 TUBE in 1 CARTON (10237-271-04) / 113 g in 1 TUBE1 tube2025-12-15NoNoCurrent
10237-271-07102370271071 TUBE in 1 CARTON (10237-271-07) / 19 g in 1 TUBE1 tube2025-09-15NoNoCurrent
10237-271-22102370271222 CARTON in 1 PACKAGE (10237-271-22) / 2 TUBE in 1 CARTON / 130 g in 1 TUBE2 carton2026-10-01NoNoCurrent
10237-271-24102370271242 TUBE in 1 CARTON (10237-271-24) / 113 g in 1 TUBE2 tube2025-08-01NoNoCurrent