FDA.reportPublic FDA data

Therabreath

Product NDC
10237-272
11-digit product format
102370272
Labeler code
10237
Product ID
10237-272_59903e71-6c38-3ffb-e063-6294a90afad7
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium 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
SODIUM FLUORIDE
Active strength
.243 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
Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ba04b55-38f9-76f3-e063-6394a90a3c03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-272-04TherabreathWhitening1 in 1 CARTONPASTE, DENTIFRICE12
10237-272-04TherabreathWhitening113 g in 1 TUBEPASTE, DENTIFRICE1132
10237-272-24TherabreathWhitening113 g in 1 TUBEPASTE, DENTIFRICE1132
10237-272-24TherabreathWhitening2 in 1 CARTONPASTE, DENTIFRICE22

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 15 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEWalmart Inc.e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEWalmart Inc.1fd2f3ca-066e-282a-e063-6294a90a05a92026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.af5b93e7-5cce-4e01-8df2-54494d8b29102026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.4590ca97-130c-46b2-9ba0-38f4703ef30a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32a92add-c9db-4733-8e35-613825fdf0812026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32ebc633-5338-4d5a-b075-f10b247612482026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEH E B51ddc81b-1c90-4998-b538-6761ac1134372026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.9a0b6301-2443-41f7-adeb-87578a65c26d2026-02-24Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.344c9d00-ad82-46a9-83e9-68197e1a68bb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Complete Oral RinseANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.27c33ae1-52c7-baad-e063-6394a90a06112026-02-23WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.001777fb-196c-499a-94c8-6cdcef0958e92026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEMeijer, Inc.c628d02f-c834-42b3-b38d-6b9cdcdd09612026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEMeijer, Inc.b17f7a5d-272e-446d-803b-46a6d8e5f18f2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEMeijer, Inc.d85ce60c-ebff-461f-827a-10fddb9c2bf32026-02-19Warnings, Adverse reactionsExact identifier
application number: M021
White Glo Charcoal Baking Soda Maximum White Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc580c4622-6f9c-48ea-b01e-6ffba7273f242026-02-19WarningsExact identifier
application number: M021
White Glo Coffee and Tea Stain Remover Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Incf044e213-2403-4f42-a41d-72d58fefcfcb2026-02-19WarningsExact identifier
application number: M021
White Glo Mouthwash Protect Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4691584f-8c0c-4589-8b40-89b1779a438d2026-02-19WarningsExact identifier
application number: M021
White Glo Professional Choice Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inced8d7506-0385-4422-be77-bcc2db79882f2026-02-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEMeijer, Inc.c4dcb1d8-f2af-4363-8fcd-c7d1197d66ea2026-02-19Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN3ba04b55-38f9-76f3-e063-6394a90a3c032
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3ba04b55-38f9-76f3-e063-6394a90a3c032
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3ba04b55-38f9-76f3-e063-6394a90a3c032
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3ba04b55-38f9-76f3-e063-6394a90a3c032
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3ba04b55-38f9-76f3-e063-6394a90a3c032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-272-04102370272041 TUBE in 1 CARTON (10237-272-04) / 113 g in 1 TUBE1 tube2025-12-15NoNoCurrent
10237-272-07102370272071 TUBE in 1 CARTON (10237-272-07) / 19 g in 1 TUBE1 tube2026-08-21NoNoCurrent
10237-272-24102370272242 TUBE in 1 CARTON (10237-272-24) / 113 g in 1 TUBE2 tube2025-08-01NoNoCurrent