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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Lidl US, LLC	c47475aa-3125-410f-aa31-0add6e4ce125	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f4c02924-95ee-09d2-e053-2995a90a8121	2026-02-03		Exact identifier application number: M021
Crest 3D White Stain Eraser Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5d97011-7be3-3b1c-e053-2a95a90ade86	2026-02-03		Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc.	c28c3475-efbb-4099-83ab-ab91bac9dfc3	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	65abfb4d-3a1e-42df-b343-f270ce60a3bf	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	102e4d9c-0fae-d48a-e063-6294a90aac94	2026-02-03	Warnings	Exact identifier application number: M021
Crest Plus Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08767b0f-ed6e-8d32-e063-6294a90a10cd	2026-02-03	Warnings	Exact identifier application number: M021
Crest Braces Care Anticavity Fluoride Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d8398cfd-9af6-690d-e053-2995a90a9b7c	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	d859d02d-a036-4d90-bed4-9a5c31e9e1ef	2026-02-03	Warnings	Exact identifier application number: M021
Glowing White	SODIUM FLUORIDE	Demoulas Super Markets, Inc	32faf47d-b64f-4454-9f14-51503504c6b5	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Sodium fluoride	SODIUM FLUORIDE	Demoulas Super Markets, Inc	2f5d3c75-1a11-47e1-b297-e2302177efe7	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc	096e6a1d-316b-432a-bf27-70e8a13337cc	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	49d1932f-a85c-7b8f-e063-6394a90a6aca	2026-02-02	Warnings	Exact identifier application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash	SODIUM FLUORIDE	Kenvue Brands LLC	49d4f96f-e61f-e6e6-e063-6294a90ab0a0	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Toy Story Wild West Watermelon	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d69901-0b07-b07d-e063-6394a90a3c34	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Frozen Blizzard Berry	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d6c1c9-cd21-cac6-e063-6294a90a81d6	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Disney Princesses Grand Grape	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d6f926-da4e-26df-e063-6294a90a1c0c	2026-02-02	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	49d70b88-d57c-37cd-e063-6294a90a4a59	2026-02-02	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Rite Aid Corporation	54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe	2026-02-02	Warnings, Adverse reactions	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