FDA.reportPublic FDA data

Therabreath

Product NDC
10237-270
11-digit product format
102370270
Labeler code
10237
Product ID
10237-270_3c372f26-e0c5-0659-e063-6294a90ae9f9
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Therabreath
Brand name suffix
Deep Clean
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.454 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
3c372f26-e0c4-0659-e063-6294a90ae9f9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-270-04TherabreathDeep Clean113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-270-04TherabreathDeep Clean1 in 1 CARTONPASTE, DENTIFRICE11
10237-270-24TherabreathDeep Clean113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-270-24TherabreathDeep Clean2 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 1 of 52 · 1,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
TOTAL TP CLEAN MINT PSTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-05WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIESSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRYSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-04WarningsExact identifier
application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide WhiteningSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN3c372f26-e0c4-0659-e063-6294a90ae9f91
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD3c372f26-e0c4-0659-e063-6294a90ae9f91
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY3c372f26-e0c4-0659-e063-6294a90ae9f91
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY3c372f26-e0c4-0659-e063-6294a90ae9f91
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY3c372f26-e0c4-0659-e063-6294a90ae9f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-270-04102370270041 TUBE in 1 CARTON (10237-270-04) / 113 g in 1 TUBE1 tube2025-12-15NoNoCurrent
10237-270-24102370270242 TUBE in 1 CARTON (10237-270-24) / 113 g in 1 TUBE2 tube2025-08-01NoNoCurrent