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 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	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