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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro Health Sensitive and Enamel Shield	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb48b15c-f821-e5cd-e053-6294a90ac64c	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Luminous Purple	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	fbfcd837-4d88-5f82-e053-6394a90afbf6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health with a Touch of Scope	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb572b41-36cd-55d7-e053-6394a90a71c8	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Whitening Gel	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	fb5b1e94-bed6-8486-e053-6294a90a3a84	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Ultra Vivid Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	cba96ef0-0519-059f-e053-2a95a90a43ad	2026-01-08	Warnings	Exact identifier application number: M021
Crest 4in1	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	ce545406-3c4f-1ba7-e053-2a95a90a91ac	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d218ddc0-1d5f-f39b-e053-2995a90a96ed	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Antibacterial Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d58bc842-2687-e52d-e053-2995a90a5433	2026-01-08	Warnings	Exact identifier application number: M021
Scope Stay Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d65b3153-2026-a8c0-e053-2a95a90a31d6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Whitening Charcoal	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d6f68485-b92f-41c7-e053-2995a90a4fe5	2026-01-08	Warnings	Exact identifier application number: M021
KIDS Crest Advanced Enamel Plus Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d837ecde-249a-7868-e053-2a95a90a56ae	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Whitening Intensive Cleaning	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d6fa4187-a651-647b-e053-2995a90a8567	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Gum Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d7729dde-c828-34e6-e053-2a95a90a5ee6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Densify Daily Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d811306f-4994-7a5a-e053-2995a90adf16	2026-01-08	Warnings	Exact identifier application number: M021
Crest Densify Daily Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d810d4e5-ba66-efe1-e053-2995a90abfc0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Braces Care Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d823cba4-c4cf-7d7a-e053-2995a90a01f0	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Sensitive Relief	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d7730674-7513-52cf-e053-2995a90ab32c	2026-01-08	Warnings	Exact identifier application number: M021
Kids Crest Bubblegum Flavor	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	26a7a892-5da4-4749-bbb6-566efab7d749	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Plus Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	8c91095d-88c0-4d22-a79a-7d0f0d05302b	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Advanced Deep Clean Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	d774295f-8ebd-9877-e053-2a95a90a9a0e	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