Ipana Wintergreen Fluoride

Product NDC: 69510-010
11-digit product format: 695100010
Labeler code: 69510
Product ID: 69510-010_3b02acf1-478c-5a1f-e063-6294a90a9a1c
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM MONOFLUOROPHOSPHATE
Dosage form: PASTE
Route: DENTAL
Labeler: Maxill Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-31
Marketing end: 2029-07-31
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: .1 g/100g
NDC exclude flag: No
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: Ipana Wintergreen Fluoride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	.1 g/100g

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
5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69510-010-19	Ipana Wintergreen Fluoride	1 in 1 BOX	PASTE	1		9
69510-010-19	Ipana Wintergreen Fluoride	19 g in 1 TUBE	PASTE	19		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM MONOFLUOROPHOSPHATE	ACTIVE INGREDIENT	C810JCZ56Q	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
Carboxymethylcellulose	INACTIVE INGREDIENT	05JZI7B19X	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69510-010	IPANA WINTERGREEN FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [MAXILL INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241018_5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0.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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cloveden Sensitive Care Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	3fb153f1-ba6e-7251-e063-6294a90abe62	2025-09-26	Warnings	Exact identifier application number: M021
Cloveden 100 times higher concentrated	CETYLPYRIDINIUM CHLORIDE	DONG IL PHARMS CO.,LTD	3fb1a2ee-381e-a9e8-e063-6394a90a864b	2025-09-26	Warnings	Exact identifier application number: M021
unpa Cha Cha Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Lycl Inc.	230b3cf2-053a-4e8b-8d50-05bbc877faa8	2025-09-25	Warnings	Exact identifier application number: M021
TheraBreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c5d58f1-ea8c-4708-bbc6-21e1cd1446da	2025-09-19	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1	2025-09-18	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	c1bbdd36-53fb-43a3-ba20-afbeb6359d31	2025-09-18	Warnings	Exact identifier application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	f70d378b-d4d6-454c-90a9-794459960c8c	2025-09-17	Warnings	Exact identifier application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	26b9b2dd-7cb2-47c3-8bbb-94a48f02dd21	2025-09-16	Warnings	Exact identifier application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	3436532d-e078-4dbb-a823-b4542e961534	2025-09-16	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Fresh Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	9b1671c4-8680-6e2a-9f10-0400840ca5a9	2025-09-12	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	ddc09ce5-181a-1b50-7094-314bb58a15cf	2025-09-12	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint Anticavity Mouthwash	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	3efc66b2-fcf9-4d26-9cdd-1af8225312b4	2025-09-10	Warnings	Exact identifier application number: M021
CLOSE UP Freshening with Mouthwash	SODIUM FLUORIDE	Church & Dwight Co., Inc.	e660b0d7-4cc5-4028-bdf5-016b85899728	2025-09-09	Warnings	Exact identifier application number: M021
Essentials Healthy Teeth and Gums	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	9652c004-6b47-840f-e053-2995a90a6e98	2025-09-09	Warnings	Exact identifier application number: M021
Complete Care Whole Mouth Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	d00f9d16-de0e-4ffc-e053-2a95a90a2069	2025-09-09	Warnings	Exact identifier application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	e911effb-d59f-4054-9501-803b64369ab4	2025-09-05	Warnings	Exact identifier application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	HISMILE PTY LTD	3de10638-1a39-b747-e063-6294a90a4ca5	2025-09-03	Warnings	Exact identifier application number: M021
Optimax Purple Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8264e849-a6b3-4953-a85b-da9d4e7f5a70	2025-09-02	Warnings	Exact identifier application number: M021
CAREKON ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.	3baca3b6-ff48-0579-e063-6394a90abd08	2025-08-29	Warnings	Exact identifier application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc.	fc794fe5-7135-4b2b-b002-a75908223f20	2025-08-13	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	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	9
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	9
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69510-010-19	69510001019	1 TUBE in 1 BOX (69510-010-19) / 19 g in 1 TUBE	1 tube	2015-01-05	2029-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ipana Wintergreen Fluoride	Maxill Inc. \| AmLion Toothpaste Sdn. Bhd	2025-07-28	HUMAN OTC DRUG LABEL	9