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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	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