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
Ingredient	Strength
SODIUM FLUORIDE	.24 g/100g
POTASSIUM NITRATE	5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup
RU45X2JN0Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038929	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
4b812a38-f7cb-51c8-e063-6394a90ab82c	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
10237-273-04	TheraBreath	1 in 1 CARTON	PASTE, DENTIFRICE	1	1
10237-273-04	TheraBreath	113 g in 1 TUBE	PASTE, DENTIFRICE	113	1
10237-273-24	TheraBreath	113 g in 1 TUBE	PASTE, DENTIFRICE	113	1
10237-273-24	TheraBreath	2 in 1 CARTON	PASTE, DENTIFRICE	2	1

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 23 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Densify Pro Intensive Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f45c9c89-f294-deca-e053-2a95a90ae557	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a00de-b16a-66e6-e053-2995a90aedc6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Gentle Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a7dc7-77f3-3911-e053-2a95a90ad55c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	961295a6-79ae-44b1-e053-2995a90a6130	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Intensive Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2118d-1216-d0d0-e053-2995a90a7088	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	96247083-39e9-7ca7-e053-2995a90a75d0	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Express White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2d5aa-b0e6-7068-e053-2995a90ae90c	2026-01-08	Warnings	Exact identifier application number: M021
Crest complete plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	973ce138-c64e-c059-e053-2a95a90a3148	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c3ad36-72d8-16e8-e053-2a95a90a8702	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d65b58-9818-820d-e053-2995a90a9f00	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitive and Gum All Day Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4d775a1-a4f6-cd69-e053-2995a90a5f64	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Advanced Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4ead762-17b2-22a0-e053-2a95a90ac866	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Luminous Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c82742-fb27-62a2-e053-2a95a90aa7c4	2026-01-08	Warnings	Exact identifier application number: M021
Native Whitening	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	a5248d35-f488-3457-e053-2995a90a411e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	b7882679-339c-554f-e053-2995a90afa7f	2026-01-08	Warnings	Exact identifier application number: M021
Burts Bees Kids Strawberry Splash	SODIUM FLUORIDE	Procter & Gamble Manufacturing Company	b6c180ae-00da-6fab-e053-2a95a90a089e	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Plus Scope Outlast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b6f9a813-7ed6-895c-e053-2995a90a9ea6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Dual Blast Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b788d16a-8a58-0352-e053-2a95a90a965e	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Outlast Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b789587e-7f49-163a-e053-2a95a90a823f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Advanced Whitening Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b81a22dc-b759-24cd-e053-2995a90a9148	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
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	4b812a38-f7cb-51c8-e063-6394a90ab82c	1
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	4b812a38-f7cb-51c8-e063-6394a90ab82c	1
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	4b812a38-f7cb-51c8-e063-6394a90ab82c	1
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	4b812a38-f7cb-51c8-e063-6394a90ab82c	1
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	4b812a38-f7cb-51c8-e063-6394a90ab82c	1
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	4b812a38-f7cb-51c8-e063-6394a90ab82c	1
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	4b812a38-f7cb-51c8-e063-6394a90ab82c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10237-273-04	10237027304	1 TUBE in 1 CARTON (10237-273-04) / 113 g in 1 TUBE	1 tube	2026-01-15	No	No	Current
10237-273-07	10237027307	1 TUBE in 1 CARTON (10237-273-07) / 19 g in 1 TUBE	1 tube	2026-08-21	No	No	Current
10237-273-24	10237027324	2 TUBE in 1 CARTON (10237-273-24) / 113 g in 1 TUBE	2 tube	2026-01-15	No	No	Current