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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	13910b55-9b5d-af53-e063-6294a90acf5d	2024-03-13	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	e3bb60f8-2a06-42d6-a182-8c31bb982a2a	2024-03-01	Warnings	Exact identifier application number: M021
Maximum Security	SODIUM FLUORIDE	Bob Barker Company Inc.	e29f30ec-72ea-4944-a2c2-b1696d31b639	2024-02-27	Warnings	Exact identifier application number: M021
Made by Dentists For Kids Monster Slime Sour Apple	SODIUM FLUORIDE	MADE BY DENTISTS INC	dfddc67c-3626-48c4-8120-bcc6c455d119	2024-02-23	Warnings	Exact identifier application number: M021
Orajel Gabbys Dollhouse	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cd47bd1e-44ac-465f-8529-6073ade14706	2024-02-23	Warnings	Exact identifier application number: M021
Colgate Kids Maximum Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive	c44c7a7e-fc3e-a81b-1961-ff89614b678f	2024-02-22	Warnings	Exact identifier application number: M021
TheraBreath Fresh Breath Anticavity Mild Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	19ce5324-7d8d-4d70-ad9b-238f7e612eac	2024-02-06	Warnings	Exact identifier application number: M021
Nature Mint Anticavity	SODIUM MONOFLUOROPHOSPHATE	Bob Barker Company Inc.	916891d3-5234-46a8-a492-21a31f36a852	2024-02-02	Warnings	Exact identifier application number: M021
Treatment Rinse Mint	ANTICARIES	DENTAL ALLIANCE HOLDINGS LLC	f1255065-b7c3-4eb6-e053-2995a90afcdb	2024-01-31	Warnings	Exact identifier application number: M021
Maintenance Rinse Mint	ANTICARIES	Dental Alliance Holdings LLC	f1273510-aa83-3ef9-e053-2a95a90aea27	2024-01-31	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98d839e3-a1aa-c83d-e053-2995a90a7e79	2024-01-30	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98aebbec-aec0-1478-e053-2a95a90a03ea	2024-01-30	Warnings	Exact identifier application number: M021
Toms Childrens Anticavity Mouthwash Silly Strawberry	SODIUM FLUORIDE	Tom's of Maine, Inc.	998c6f35-20f4-4cb8-bc48-6aa39e61481a	2024-01-18	Warnings	Exact identifier application number: M021
Gel-Kam Fruit and Berry	STANNOUS FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	2024-01-18	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	9a976ac8-d966-4d94-93da-45652f2d2481	2024-01-12	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	2b4b6f9a-0e31-4891-8721-d1b9a58cca96	2024-01-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	51abd6bc-7a3d-4b0e-a810-af9e94926438	2024-01-09	Warnings	Exact identifier application number: M021
Colgate Enamel Strength Mouthwash	SODIUM FLUORIDE	Colgate-Palmolive - do not use	f0cca38b-c0a3-4788-8cca-727a5684c16b	2024-01-09	Warnings	Exact identifier application number: M021
PerCara Oral Health Rinse Fresh Mint	CETYLPYRIDINIUM CHLORIDE	LEC Custom Products, Inc	bd98c654-218b-15ac-e053-2a95a90a75d1	2024-01-01	Warnings	Exact identifier application number: M021
PerCara Kids Bubble Gum	SODIUM FLUORIDE	LEC Custom Products, Inc.	be3a7272-acfb-7d14-e053-2995a90a9420	2024-01-01	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