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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Clean Breath Peppermint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ef07b-ee68-e6ae-e063-6394a90af5e5	2026-04-10	Warnings	Exact identifier application number: M021
Crest Clean Breath Spearmint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f20343e-6c03-48e8-e063-6294a90a8cdf	2026-04-10	Warnings	Exact identifier application number: M021
Crest Clean Breath Smooth Mint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f2042b4-8eae-5c2c-e063-6394a90a640c	2026-04-10	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef4146d-6281-fe66-e063-6394a90a32c3	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef5261e-9d2f-ae05-e063-6294a90a489a	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f0876d9-41c9-d891-e063-6394a90a1cbd	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef57a05-b9f5-42f7-e063-6294a90a5d89	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ee26a82-16fd-f0fb-e063-6394a90a91d1	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Whitening Therapy Deep Clean Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	812c1519-1a4b-2495-e053-2a91aa0a914a	2026-04-09	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting Foam	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4ef4e7c2-1f58-59fc-e063-6294a90ad43b	2026-04-08	Warnings	Exact identifier application number: M021
Anticavity mouth rinse Low-foaming Spearmint	779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT	Dyson Technology Limited	4ef669b9-defe-8965-e063-6394a90ab335	2026-04-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Radiant Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5c89efc-5fa0-2a05-e053-2a95a90a7b9c	2026-04-07	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Charcoal	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4eb8111-53da-17ae-e053-2a95a90a1127	2026-04-07	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	ADUSA Distribution, LLC	35385ada-bd8d-4d38-9587-0256885f749f	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	ADUSA Distribution, LLC	cf0c8b48-0d1c-406a-a67d-7d16187d38d8	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Arctic Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	fa08a877-b9e5-4eba-b832-3a28f4f3f83c	2026-04-07	Warnings	Exact identifier application number: M021
Anticavity Fluoride	SODIUM FLUORIDE	Family Dollar (FAMILY WELLNESS)	63c4c0e9-84b1-4076-bdf4-7e9543b2cf46	2026-04-01	Warnings	Exact identifier application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	2026-04-01	Warnings	Exact identifier application number: M021
CloSYS	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	5f87abb7-0e9d-6369-e053-2a91aa0a2411	2026-03-31	Warnings	Exact identifier application number: M021
Crest Clean Breath Spearmint	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4e544d09-0cf3-f0c7-e063-6394a90a2369	2026-03-31	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