TheraBreath Anticavity

Product NDC: 10237-265
11-digit product format: 102370265
Labeler code: 10237
Product ID: 10237-265_3e626c65-3a8b-ec3c-e063-6394a90ad8f4
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: 2024-08-15
Substance: SODIUM FLUORIDE
Active strength: .002 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 Anticavity
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.002 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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3c5d58f1-ea8c-4708-bbc6-21e1cd1446da	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-265-01	TheraBreath Anticavity	1000 mL in 1 BOTTLE, PLASTIC	RINSE	1000	3
10237-265-21	TheraBreath Anticavity	2 in 1 PACKAGE	RINSE	2	3
10237-265-21	TheraBreath Anticavity	1000 mL in 1 BOTTLE	RINSE	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-265	THERABREATH ANTICAVITY (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.]	2	Current NDC, 3 package rows	20241129_3c5d58f1-ea8c-4708-bbc6-21e1cd1446da.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 26 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Complete Plus Active Fresh plus Whitening Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c599d33f-788f-7fdd-e053-2a95a90a5f57	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi Benefit Whitening plus Scope Outlast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	66c41b24-d394-6609-e053-2a91aa0a0a2c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Plus 3 in 1	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b6fab2eb-da5c-749f-e053-2995a90a1357	2026-01-08	Warnings	Exact identifier application number: M021
Crest Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	85477763-1db5-482f-90e5-e71f5c1b4765	2026-01-08	Warnings	Exact identifier application number: M021
Crest Fresh and White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f9b31f6b-6b3f-abe0-e053-6294a90acb25	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c367c2cc-5e0f-bc4e-e053-2995a90a2e2c	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Glamorous White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c3f29f95-81b9-3989-e053-2a95a90af3a6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete plus Whitening plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c5d5bc17-e81b-34aa-e053-2a95a90ad77f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c5745cc4-213d-1dde-e053-2995a90af562	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Shield	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	960fef18-4533-5250-e053-2995a90aaf76	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Gum Restore Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c574b51d-07bd-b363-e053-2995a90a7c0e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Blast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d9a1754-8d38-054f-e053-2991aa0a4653	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Breath Purify and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c60fdacf-d997-19a5-e053-2a95a90a96a3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	3d7fffb9-47e0-73cd-e054-00144ff88e88	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Ultra	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c73ed36a-0e2f-a137-e053-2a95a90a43e0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Extra Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c688d37e-9e80-4599-e053-2a95a90a1916	2026-01-08	Warnings	Exact identifier application number: M021
Crest Gum Detoxify plus Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	63779942-0f6c-11c5-e053-2991aa0a25ab	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Sensitivity Active Foam	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	b8535d1c-cf15-f353-e053-2a95a90a7974	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Extra White Zen Peppermint	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	81279e1f-6224-8114-e053-2991aa0aab08	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	c74229c4-b095-df32-e053-2a95a90a4aec	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10237-265-01	10237026501	1000 mL in 1 BOTTLE, PLASTIC (10237-265-01)	1000 ml	2024-08-15	No	No	Current
10237-265-21	10237026521	2 BOTTLE in 1 PACKAGE (10237-265-21) / 1000 mL in 1 BOTTLE	2 bottle	2026-01-01	No	No	Current