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 23 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 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
Crest Premium Plus Deep Clean Active Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	b851fe5c-d904-12da-e053-2a95a90a86f9	2026-01-08	Warnings	Exact identifier application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	adebbd47-011d-4cd3-a002-1eb67e885e5b	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Stain Shield	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c9b5ef-8dd4-a842-e053-2a95a90ad387	2026-01-08	Warnings	Exact identifier application number: M021
Kids Crest Bubblegum Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7baa77f5-fe45-6566-e053-2991aa0a381f	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Vibrant Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f63c3354-a264-8130-e053-2a95a90a2022	2026-01-08		Exact identifier application number: M021
Crest Pro Health Clean Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb466fb4-0915-a41f-e053-6294a90a2dfb	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Clean and Free	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb4771cd-f478-e2bd-e053-6394a90aa83e	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