Orajel Complete Protection

Product NDC: 10237-677
11-digit product format: 102370677
Labeler code: 10237
Product ID: 10237-677_1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE
Route: ORAL
Labeler: Church & Dwight Co., Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-01
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: .243; 5 g/100g; g/100g
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: Orajel Complete Protection
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.243 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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
daebd16f-d278-446d-8b7a-33add5a74fdd	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10237-677-12	Orajel Complete Protection	170 g in 1 TUBE	PASTE	170	3
10237-677-12	Orajel Complete Protection	2 in 1 CARTON	PASTE	2	3
10237-677-43	Orajel Complete Protection	121.9 g in 1 TUBE	PASTE	121.9	3
10237-677-43	Orajel Complete Protection	1 in 1 CARTON	PASTE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-677	ORAJEL COMPLETE PROTECTION (SODIUM FLUORIDE) PASTE [CHURCH & DWIGHT CO., INC.]	3	Current NDC, 4 package rows	20240404_daebd16f-d278-446d-8b7a-33add5a74fdd.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
United Airlines Therabody Polaris Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	ab667740-55ab-470e-9514-163961502ceb	2023-10-26	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	0ae98f28-7e78-4379-93b0-4f2657415c4d	2023-10-25	Warnings	Exact identifier application number: M021
Tanners Tasty Vanilla Bling	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	521fe01e-7f2e-4d79-9126-e4880cdf4e71	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Ooh La La Orange	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	6027b961-314e-4f71-8b2f-646ce80214d8	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Cha Cha Chocolate	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	8609dbf3-7620-4a13-b40b-6bd705a78fb0	2023-10-24	Warnings	Exact identifier application number: M021
Glister Multi-Action	SODIUM FLUORIDE	Access Business Group LLC	e3f2c049-a0f5-4649-a4aa-11bdb252f951	2023-10-23	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD	082a581a-c7e5-e614-e063-6394a90a87da	2023-10-20	Warnings	Exact identifier application number: M021
Plak Smacker Anti Cavity Fluoride	SODIUM FLUORIDE	YOUNG PS ACQUISITION, LLC	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2023-10-16	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	152d84ee-d981-4032-bfb1-a559afe71d40	2023-10-11	Warnings	Exact identifier application number: M021
Sodium Fluoride	SODIUM FLUORIDE	Safco Dental Supply LLC	788080b3-fff8-4049-af98-f571824994c2	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	042636cf-8b61-4022-b0a1-af09c06b145b	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	f4c3569b-7b6a-4566-9e87-492f291c5165	2023-10-11	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	Procurall Solutions	042817f9-675f-056a-e063-6394a90a2d97	2023-08-30	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10237-677-12	10237067712	2 TUBE in 1 CARTON (10237-677-12) / 170 g in 1 TUBE	2 tube	2024-05-01	No	No	Current
10237-677-43	10237067743	1 TUBE in 1 CARTON (10237-677-43) / 121.9 g in 1 TUBE	1 tube	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orajel ™ Complete Protection Toothpaste	Church & Dwight Co., Inc.	2023-12-19	HUMAN OTC DRUG LABEL	3