FDA.reportPublic FDA data

TheraBreath

Product NDC
10237-273
11-digit product format
102370273
Labeler code
10237
Product ID
10237-273_59906b37-9bbf-710d-e063-6294a90abee4
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-15
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.24; 5 g/100g; 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b812a38-f7cb-51c8-e063-6394a90ab82cAvailable 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
10237-273-04TheraBreath1 in 1 CARTONPASTE, DENTIFRICE11
10237-273-04TheraBreath113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-273-24TheraBreath113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-273-24TheraBreath2 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 8 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Premium Plus Scope Active Foam plus Whitening Dualblast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5500f9ab-b0c4-51d6-e063-6394a90acd382026-06-24WarningsExact identifier
application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5504ec96-aae1-f5f9-e063-6294a90ad8bb2026-06-24WarningsExact identifier
application number: M021
COLGATE SPARKLING WHITE CINNAMINTSODIUM FLUORIDEColgate-Palmolive Companyf2ff18d2-4ef0-454e-a6f1-6f3bf361c7d12026-06-24WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.fdbadaae-eab7-4d9a-acf7-815ca93f877c2026-06-16WarningsExact identifier
application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.ebb62015-0027-459a-a9cf-56b640f9f4562026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.b9962eac-186e-4da2-929d-393f18ed02342026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.1c029b10-29b0-4131-9134-cebfca4328a32026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTARSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.3e7ab39a-989c-4924-af3e-689404912bee2026-06-16WarningsExact identifier
application number: M021
Crest Plus Cinnamon plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company53fb780d-3e8b-6747-e063-6294a90a82112026-06-11WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY7f6b6aa8-50da-151b-c448-9e427d37398f2026-06-11WarningsExact identifier
application number: M021
Colgate MaxClean with Whitening SmartfoamSODIUM FLUORIDEColgate-Palmolive Companyc712ae6b-eff3-4c54-b1fc-37304758d0592026-06-11WarningsExact identifier
application number: M021
Colgate Total Sensitivity Mineral ShieldSTANNOUS FLUORIDEColgate-Palmolive Companyf065318c-1e2a-c04d-f254-f8127b05a88f2026-06-10WarningsExact identifier
application number: M021
Toms Whole Care Mouthwash Fresh MintSODIUM FLUORIDETom's of Maine, Inc.6875f5c1-853c-43da-8226-c09a5518f9bb2026-06-10WarningsExact identifier
application number: M021
Colgate Total SF Fresh Mint StripeSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY657020c7-e85c-4c61-9f62-b50351e4b4e52026-06-10WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride BubblegumSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc1adc752b-2ba8-4d8f-b4f1-5741f864255b2026-06-09WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.df182c22-bbf1-448d-81e8-35cb431d2afc2026-06-08WarningsExact identifier
application number: M021
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN4b812a38-f7cb-51c8-e063-6394a90ab82c1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD4b812a38-f7cb-51c8-e063-6394a90ab82c1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4b812a38-f7cb-51c8-e063-6394a90ab82c1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY4b812a38-f7cb-51c8-e063-6394a90ab82c1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4b812a38-f7cb-51c8-e063-6394a90ab82c1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4b812a38-f7cb-51c8-e063-6394a90ab82c1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY4b812a38-f7cb-51c8-e063-6394a90ab82c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-273-04102370273041 TUBE in 1 CARTON (10237-273-04) / 113 g in 1 TUBE1 tube2026-01-15NoNoCurrent
10237-273-07102370273071 TUBE in 1 CARTON (10237-273-07) / 19 g in 1 TUBE1 tube2026-08-21NoNoCurrent
10237-273-24102370273242 TUBE in 1 CARTON (10237-273-24) / 113 g in 1 TUBE2 tube2026-01-15NoNoCurrent