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 7 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT	SODIUM FLUORIDE	Colgate-Palmolive Company	9aaa451d-8827-41b7-9661-bc1a7a69cfc3	2026-06-30	Warnings	Exact identifier application number: M021
CrestPlus Deep Clean plus Whitening Effervescent Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5579be77-97df-1000-e063-6294a90a4725	2026-06-30	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	358842de-3e1d-4f66-8d08-fe8538441b34	2026-06-29	Warnings	Exact identifier application number: M021
Anticavity mouth rinse Low-foaming Spearmint	718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT	Dyson Technology Limited	5356d0a8-2db4-ce7f-e063-6394a90aa6d2	2026-06-26	Warnings	Exact identifier application number: M021
Colgate Optic White Renewal Brilliant Shine	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	70734d67-fc3e-4515-b6e6-ab2c466578d6	2026-06-26	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	f87d6f04-507a-47ae-8a66-204cf59261c0	2026-06-26	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5513ba92-cadc-2cf3-e063-6294a90ac3e5	2026-06-25	Warnings	Exact identifier application number: M021
Crest Plus Active Fresh Scope plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5513e40f-b8e8-2d9a-e063-6394a90ab170	2026-06-25	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Mint Splash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6c690e-a1bb-4606-e063-6394a90ac4b6	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Polishing Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f1bbc3d-a1f9-b278-e063-6294a90a62f7	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f1bd56c-dac8-eb87-e063-6294a90a3cc1	2026-06-25		Exact identifier application number: M021
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f0b1d46-d52c-f409-e063-6394a90a5574	2026-06-25		Exact identifier application number: M021
Crest Plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5514e09e-0a7d-93e6-e063-6294a90ae3f0	2026-06-25	Warnings	Exact identifier application number: M021
Colgate Sparkling White Mint Zing	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	0c2fe62b-4905-4213-a85b-e073d8eeb741	2026-06-24	Warnings	Exact identifier application number: M021
Colgate MaxFresh Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	890c4c29-bba8-4775-a053-10c6292df930	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Active Foam Whitening scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55004d9d-eda7-a285-e063-6294a90ad4ca	2026-06-24	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	5500686c-d417-c50a-e063-6294a90ac7fa	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5500f9ab-b0c4-51d6-e063-6394a90acd38	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5504ec96-aae1-f5f9-e063-6294a90ad8bb	2026-06-24	Warnings	Exact identifier application number: M021
COLGATE SPARKLING WHITE CINNAMINT	SODIUM FLUORIDE	Colgate-Palmolive Company	f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1	2026-06-24	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