FDA.reportPublic FDA data

Therabreath Overnight Chamomile Mint

Product NDC
10237-262
11-digit product format
102370262
Labeler code
10237
Product ID
10237-262_45a8183b-aa06-ed02-e063-6394a90a46f5
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
RINSE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-22
Substance
SODIUM FLUORIDE
Active strength
5 mg/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Overnight Chamomile Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 mg/10mL

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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc0c533c-145e-4877-b421-1baf3a3a572eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-262-16Therabreath Overnight Chamomile Mint473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-262-26Therabreath Overnight Chamomile Mint2 in 1 PACKAGERINSE24
10237-262-26Therabreath Overnight Chamomile Mint473 mL in 1 BOTTLE, PLASTICRINSE4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-262THERABREATH OVERNIGHT CHAMOMILE MINT (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.]2Current NDC, 3 package rows20241122_cc0c533c-145e-4877-b421-1baf3a3a572e.zip

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 18 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEDemoulas Super Markets, Inc6391ca2e-10e8-429d-a873-238a515f9c602026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc.c28c3475-efbb-4099-83ab-ab91bac9dfc32026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEDemoulas Super Markets, Inc65abfb4d-3a1e-42df-b343-f270ce60a3bf2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company102e4d9c-0fae-d48a-e063-6294a90aac942026-02-03WarningsExact identifier
application number: M021
Crest Plus Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08767b0f-ed6e-8d32-e063-6294a90a10cd2026-02-03WarningsExact identifier
application number: M021
Crest Braces Care Anticavity Fluoride RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd8398cfd-9af6-690d-e053-2995a90a9b7c2026-02-03WarningsExact identifier
application number: M021
AutoBrush bubblegumSODIUM FLUORIDELander Enterprises, LLC2e85d6f7-2df8-4eb9-bc97-d7b7af7fb4602026-02-03WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLCd859d02d-a036-4d90-bed4-9a5c31e9e1ef2026-02-03WarningsExact identifier
application number: M021
Glowing WhiteSODIUM FLUORIDEDemoulas Super Markets, Inc32faf47d-b64f-4454-9f14-51503504c6b52026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Sodium fluorideSODIUM FLUORIDEDemoulas Super Markets, Inc2f5d3c75-1a11-47e1-b297-e2302177efe72026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc096e6a1d-316b-432a-bf27-70e8a13337cc2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNcc0c533c-145e-4877-b421-1baf3a3a572e4
240698sodium fluoride 0.5 MG/ML MouthwashSCDcc0c533c-145e-4877-b421-1baf3a3a572e4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYcc0c533c-145e-4877-b421-1baf3a3a572e4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN4618e390-9039-a1d0-e063-6294a90ab2941
240698sodium fluoride 0.5 MG/ML MouthwashSCD4618e390-9039-a1d0-e063-6294a90ab2941
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY4618e390-9039-a1d0-e063-6294a90ab2941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-262-1610237026216473 mL in 1 BOTTLE, PLASTIC (10237-262-16) 473 ml2024-01-22NoNoCurrent
10237-262-26102370262262 BOTTLE, PLASTIC in 1 PACKAGE (10237-262-26) / 473 mL in 1 BOTTLE, PLASTIC2024-01-22NoNoCurrent