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
Ingredient	Strength
SODIUM FLUORIDE	5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240698	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
cc0c533c-145e-4877-b421-1baf3a3a572e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-262-16	Therabreath Overnight Chamomile Mint	473 mL in 1 BOTTLE, PLASTIC	RINSE	473	4
10237-262-26	Therabreath Overnight Chamomile Mint	2 in 1 PACKAGE	RINSE	2	4
10237-262-26	Therabreath Overnight Chamomile Mint	473 mL in 1 BOTTLE, PLASTIC	RINSE	473	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-262	THERABREATH OVERNIGHT CHAMOMILE MINT (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.]	2	Current NDC, 3 package rows	20241122_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 27 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest 3D White Brilliance Advanced Whitening Fresh Mint	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	c8350ab3-9347-58c0-e053-2995a90a7238	2026-01-08		Exact identifier application number: M021
Crest Premium Plus Anti-Bacterial	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	b7af946e-1cac-b8c0-e053-2a95a90afa4a	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ddcb0871-9900-125f-e053-2a95a90a75de	2026-01-08		Exact identifier application number: M021
Burts Bees Deep Clean plus Whitening	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	c924b8dd-8d84-1329-e053-2995a90a4531	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	07ed767e-225c-e9c5-e063-6394a90af931	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	0813171e-bda5-b004-e063-6394a90ad364	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Kids Strawberry Splash	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	087b3434-2636-74ce-e063-6394a90a25ad	2026-01-08	Warnings	Exact identifier application number: M021
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08776dfc-b07a-3729-e063-6394a90aeeed	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Active Fresh plus Whitening Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	17f3b749-01ea-2561-e063-6294a90a5d3b	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Deep Clean	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	128613c4-c06b-bdf5-e063-6294a90acd34	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	13a01190-a6f3-17b3-e063-6294a90a36c2	2026-01-08	Warnings	Exact identifier application number: M021
HEB HEBuddy	FLUORIDE	HEB	2c972c65-34aa-4348-b997-c5e65a884575	2026-01-08	Warnings	Exact identifier application number: M021
ARC 2 in 1 Whitening and Anticavity	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	12634efa-35e3-76d7-e063-6294a90a3de4	2026-01-08		Exact identifier application number: M021
Crest Plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	15482445-39f3-7e02-e063-6294a90ad1dc	2026-01-08	Warnings	Exact identifier application number: M021
H E B Restore and Defend	FLUORIDE	HEB	56080493-9ab8-4b4f-be5f-7df22dee133f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon Expressions plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	151d2a0a-448f-7744-e063-6294a90acd3b	2026-01-08	Warnings	Exact identifier application number: M021
Oral B Mouth Sore Special Care Rinse	HYDROGEN PEROXIDE	The Procter & Gamble Manufacturing Company	22e2dc15-5794-28ed-e063-6394a90a36d3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Anti-Cavity Max Cavity	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	15d70b80-3b25-bc32-e063-6394a90a163e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Bright Mint	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	1dee0584-0fed-61c6-e063-6394a90adbcd	2026-01-08	Warnings	Exact identifier application number: M021
HEB Gleaming White Arctic Mint	SODIUM FLUORIDE	HEB	8248eddb-20a5-7084-e053-2991aa0a16b5	2026-01-08	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	cc0c533c-145e-4877-b421-1baf3a3a572e	4
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	cc0c533c-145e-4877-b421-1baf3a3a572e	4
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	cc0c533c-145e-4877-b421-1baf3a3a572e	4
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	4618e390-9039-a1d0-e063-6294a90ab294	1
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	4618e390-9039-a1d0-e063-6294a90ab294	1
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	4618e390-9039-a1d0-e063-6294a90ab294	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10237-262-16	10237026216	473 mL in 1 BOTTLE, PLASTIC (10237-262-16)	473 ml	2024-01-22	No	No	Current
10237-262-26	10237026226	2 BOTTLE, PLASTIC in 1 PACKAGE (10237-262-26) / 473 mL in 1 BOTTLE, PLASTIC		2024-01-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TheraBreath AM-PM Twin Pack - Church & Dwight Co., Inc.	Church & Dwight Co., Inc.	2025-12-16	HUMAN OTC DRUG LABEL	1
Therabreath ™ Overnight Chamomile Mint	Church & Dwight Co., Inc.	2025-12-11	HUMAN OTC DRUG LABEL	4