MIPaste One

Product NDC: 61596-400
11-digit product format: 615960400
Labeler code: 61596
Product ID: 61596-400_4651d664-464b-05c1-e063-6394a90a565e
Type: HUMAN OTC DRUG
Nonproprietary name: MIPaste One
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: GC America Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-02-03
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 5; .24 g/100g; g/100g
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: MIPaste One
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	5 g/100g
SODIUM FLUORIDE	.24 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RU45X2JN0Z	Internal UNII lookup
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038929	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
d71f8e6e-7005-4b3e-e053-2995a90a6789	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61596-400-10	MIPaste One	10 in 1 BOX	PASTE, DENTIFRICE	10	3
61596-400-40	MIPaste One	46 g in 1 TUBE	PASTE, DENTIFRICE	46	3
61596-400-41	MIPaste One	1 in 1 BOX	PASTE, DENTIFRICE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61596-400	MIPASTE ONE PASTE, DENTIFRICE [GC AMERICA INC.]	2	Current NDC, Legacy NDC, 3 package rows	20240128_d71f8e6e-7005-4b3e-e053-2995a90a6789.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
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	d71f8e6e-7005-4b3e-e053-2995a90a6789	3
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	d71f8e6e-7005-4b3e-e053-2995a90a6789	3
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	d71f8e6e-7005-4b3e-e053-2995a90a6789	3
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	d71f8e6e-7005-4b3e-e053-2995a90a6789	3
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	d71f8e6e-7005-4b3e-e053-2995a90a6789	3
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	d71f8e6e-7005-4b3e-e053-2995a90a6789	3
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	d71f8e6e-7005-4b3e-e053-2995a90a6789	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61596-400-10	61596040010	10 BOX in 1 BOX (61596-400-10) / 1 TUBE in 1 BOX (61596-400-41) / 46 g in 1 TUBE (61596-400-40)	10 box	2022-02-03	0000-00-00	No	No	Current
61596-400-40	61596040040	46 g in 1 TUBE	46 g					Historical
61596-400-41	61596040041	1 in 1 BOX						Historical