Sodium Monofluorophosphate

Product NDC: 67777-181
11-digit product format: 677770181
Labeler code: 67777
Product ID: 67777-181_1c58c582-92e0-4533-e063-6394a90a9fe5
Type: HUMAN OTC DRUG
Nonproprietary name: White Toothpaste
Dosage form: PASTE
Route: DENTAL
Labeler: Dynarex Corporation
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-16
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 760 mg/g
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: Sodium Monofluorophosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	760 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C810JCZ56Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
545626	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
1be422b9-6320-ed5c-e063-6294a90a7e42	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67777-181-01	Sodium Monofluorophosphate	42.5 g in 1 TUBE	PASTE	42.5	2
67777-181-02	Sodium Monofluorophosphate	144 in 1 CASE	PASTE	144	2
67777-181-03	Sodium Monofluorophosphate	78 g in 1 TUBE	PASTE	78	2
67777-181-04	Sodium Monofluorophosphate	144 in 1 CASE	PASTE	144	2
67777-181-05	Sodium Monofluorophosphate	130 g in 1 TUBE	PASTE	130	2
67777-181-06	Sodium Monofluorophosphate	1 in 1 BOX	PASTE	1	2
67777-181-07	Sodium Monofluorophosphate	60 in 1 CASE	PASTE	60	2
67777-181-08	Sodium Monofluorophosphate	24 g in 1 TUBE	PASTE	24	2
67777-181-09	Sodium Monofluorophosphate	144 in 1 BOX	PASTE	144	2
67777-181-10	Sodium Monofluorophosphate	720 in 1 CASE	PASTE	720	2
67777-181-11	Sodium Monofluorophosphate	17 g in 1 TUBE	PASTE	17	2
67777-181-12	Sodium Monofluorophosphate	144 in 1 BOX	PASTE	144	2
67777-181-13	Sodium Monofluorophosphate	720 in 1 CASE	PASTE	720	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-181	SODIUM MONOFLUOROPHOSPHATE (WHITE TOOTHPASTE) PASTE [DYNAREX CORPORATION]	2	Current NDC, 13 package rows	20240716_1be422b9-6320-ed5c-e063-6294a90a7e42.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 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	1be422b9-6320-ed5c-e063-6294a90a7e42	2
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1be422b9-6320-ed5c-e063-6294a90a7e42	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1be422b9-6320-ed5c-e063-6294a90a7e42	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1be422b9-6320-ed5c-e063-6294a90a7e42	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1be422b9-6320-ed5c-e063-6294a90a7e42	2
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1be422b9-6320-ed5c-e063-6294a90a7e42	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67777-181-01	67777018101	42.5 g in 1 TUBE	42.5 g				Historical
67777-181-02	67777018102	144 TUBE in 1 CASE (67777-181-02) / 42.5 g in 1 TUBE (67777-181-01)	144 tube	2024-07-16	No	No	Current
67777-181-03	67777018103	78 g in 1 TUBE	78 g				Historical
67777-181-04	67777018104	144 TUBE in 1 CASE (67777-181-04) / 78 g in 1 TUBE (67777-181-03)	144 tube	2024-07-16	No	No	Current
67777-181-05	67777018105	130 g in 1 TUBE	130 g				Historical
67777-181-06	67777018106	1 in 1 BOX					Historical
67777-181-07	67777018107	60 BOX in 1 CASE (67777-181-07) / 1 TUBE in 1 BOX (67777-181-06) / 130 g in 1 TUBE (67777-181-05)	60 box	2024-07-16	No	No	Current
67777-181-08	67777018108	24 g in 1 TUBE	24 g				Historical
67777-181-09	67777018109	144 in 1 BOX					Historical
67777-181-10	67777018110	720 BOX in 1 CASE (67777-181-10) / 144 TUBE in 1 BOX (67777-181-09) / 24 g in 1 TUBE (67777-181-08)	720 box	2024-07-16	No	No	Current
67777-181-11	67777018111	17 g in 1 TUBE	17 g				Historical
67777-181-12	67777018112	144 in 1 BOX					Historical
67777-181-13	67777018113	720 BOX in 1 CASE (67777-181-13) / 144 TUBE in 1 BOX (67777-181-12) / 17 g in 1 TUBE (67777-181-11)	720 box	2024-07-16	No	No	Current