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 38 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35839b10-4c40-40e5-e063-6294a90a85b42025-05-19WarningsExact identifier
application number: M021
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride Cotton CandySODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC25f182cb-ad1e-4c13-bc79-1ec251754cf82025-05-12WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride WatermelonSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCb506df13-649f-4615-bc25-6ae08bd56b182025-05-12WarningsExact identifier
application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh MintSODIUM FLUORIDEKenvue Brands LLC346daeae-7590-176c-e063-6294a90a52ea2025-05-05WarningsExact identifier
application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.3de0d71a-7704-97dd-e063-6294a90a5d2c2025-05-01WarningsExact identifier
application number: M021
Brush Buddies Value 2 pack WhiteningSODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc636bf51d-9750-4305-ab4a-3483c9f0169b2025-04-30WarningsExact identifier
application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus ScopeSODIUM FLUORIDENavajo Manufacturing Company Inc3adb1524-0fd6-4728-b757-dcbda4cdd0fb2025-04-29WarningsExact 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