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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitive Teeth and Gums	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	935172db-d78f-0c69-e053-2a95a90a0b69	2026-07-23	Warnings	Exact identifier application number: M021
Essentials Whiten and Strengthen	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	96548550-2cd1-b757-e053-2995a90a15ea	2026-07-23	Warnings	Exact identifier application number: M021
TP COL OW Purple	SODIUM FLUORIDE	Colgate-Palmolive Company	ea0db59f-f9c0-49a8-9717-69cdf071f6e1	2026-07-23	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	00652bb2-090c-4eaa-8fc2-e0be6913a724	2026-07-22	Warnings	Exact identifier application number: M021
Colgate Ultra White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	95d06fcc-f56d-43f1-924a-3f91fda59bdf	2026-07-22	Warnings	Exact identifier application number: M021
COLGATE Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	730f40f6-6ac6-49bd-888b-c0b5818a03c8	2026-07-20	Warnings	Exact identifier application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POP	SODIUM FLUORIDE	Colgate-Palmolive Company	bf465181-01e9-44ca-91f8-03110a606774	2026-07-16	Warnings	Exact identifier application number: M021
Colgate Minions Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	16634b99-f305-48bf-ac54-a9f53797a9e5	2026-07-16	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	Dabur India Limited	56aaa9f5-7eac-11d9-e063-6294a90af3a8	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	Dabur India Limited	56aaba60-523e-6ac7-e063-6394a90a2756	2026-07-15	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	Dabur India Limited	56aac050-73e7-298c-e063-6294a90a26eb	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	Dabur India Limited	56aac7a7-c086-2fa5-e063-6294a90aa959	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	Dabur India Limited	56aad223-db88-7cf6-e063-6394a90a6b72	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	MKJ BRANDS LLC	2dcd4816-caa5-c006-e063-6394a90ac487	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	DABUR INDIA LIMITED	56acecd2-6966-2ee4-e063-6394a90a356f	2026-07-15	Warnings	Exact identifier application number: M021
Colgate Max Fresh Advanced Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	01c07c25-2748-4d90-9505-094e2c977c9c	2026-07-15	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d51c67b-7409-e5a7-e053-2a91aa0a81fa	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	476f453b-9215-0a11-e063-6294a90a5cd4	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	525662da-42be-eaa6-e063-6294a90af110	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	MKJ BRANDS LLC	526acbdd-6531-692d-e063-6394a90ab9f1	2026-07-14	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