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 31 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
application number: M021
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
application number: M021
Natural Adult FluorideSODIUM MONOFLUOROPHOSPHATEKrogera71c537e-39d9-1c3b-e053-2a95a90ac3ec2025-12-15WarningsExact identifier
application number: M021
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188d28f9-a814-0f98-e063-6294a90a106b2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b4cf935-38a6-f4fb-e063-6394a90a4bc02025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba491f4-2ad2-6e7b-e063-6394a90a9fb72025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188ac743-3ba8-4da4-e063-6294a90a8f872025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b682604-c563-01f1-e063-6294a90ab0bd2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b110db1-fcc0-377f-e063-6394a90a4d442025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74ecc4-a1e6-348f-e063-6294a90a58942025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b68315c-6afa-3f37-e063-6294a90a14e82025-12-11WarningsExact identifier
application number: M021
ANTICAVITY FLUORIDESODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD295b88e8-c4b5-c0b0-e063-6394a90aca012025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74f072-c33b-c6e2-e063-6394a90ab1e62025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba4a807-d6d5-04a0-e063-6294a90ae04d2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b617f4a-b56c-9f75-e063-6294a90a7abe2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b9ec370-eadf-92c4-e063-6294a90a90552025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVORSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1eb04296-ecb1-3ccc-e063-6294a90a9bda2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b9e7b21-0d34-74ec-e063-6294a90a1f592025-12-11Exact 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