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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACT Restoring Anticavity Fluoride Cool Mint	SODIUM FLUORIDE	Chattem, Inc.	ef63e193-5804-4b35-bae7-cad29cf4e8bc	2026-01-12	Warnings	Exact identifier application number: M021
Prime Tooth Care Blueberry	SODIUM FLUORIDE	Prime Tooth Care LLC	86642110-4572-4b8b-88f1-8d25fe05701e	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Juicy Peach	SODIUM FLUORIDE	Prime Tooth Care LLC	142f1610-3494-459f-a956-760e82169b87	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Coconut Whip	SODIUM FLUORIDE	Prime Tooth Care LLC	55e95657-9415-4d9c-ac9b-d021aa14e64d	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Hami Melon	SODIUM FLUORIDE	Prime Tooth Care LLC	0028f88d-a9fe-4cfa-a6c6-168f9689b5f6	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Mango Smoothie	SODIUM FLUORIDE	Prime Tooth Care LLC	2f2cf851-2edc-4aaf-9083-c37bc58547de	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Strawberries	SODIUM FLUORIDE	Prime Tooth Care LLC	7b4328bd-5d2d-40ca-8322-5e818e1babf9	2026-01-09	Warnings	Exact identifier application number: M021
Prime Tooth Care Summer Watermelon	SODIUM FLUORIDE	Prime Tooth Care LLC	b7c731a1-80e7-4571-a568-db0290a720c1	2026-01-09	Warnings	Exact identifier application number: M021
Kids Prime Pediatric Dental Group Anticavity for Kids	SODIUM FLUORIDE	Prime Tooth Care LLC	93259174-447d-4f7a-8e55-990eb8da5151	2026-01-09	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Enamel Protect	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f32d5708-8cb1-6499-e053-2995a90ac632	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Complete Care Anticavity Fluoride	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f3a644c0-da04-276d-e053-2a95a90abf27	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Active Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4487d78-1da8-3f33-e053-2a95a90a6d92	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Sensitive Care	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f435c1fe-7fbb-1b25-e053-2995a90aca11	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Densify Pro Intensive Repair	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f45c9c89-f294-deca-e053-2a95a90ae557	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a00de-b16a-66e6-e053-2995a90aedc6	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Detoxify Gentle Whitening	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f49a7dc7-77f3-3911-e053-2a95a90ad55c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	961295a6-79ae-44b1-e053-2995a90a6130	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Enamel Repair and Gum Intensive Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2118d-1216-d0d0-e053-2995a90a7088	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Charcoal	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	96247083-39e9-7ca7-e053-2995a90a75d0	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Express White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f4c2d5aa-b0e6-7068-e053-2995a90ae90c	2026-01-08	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