SparkleFresh

Product NDC: 53329-083
11-digit product format: 533290083
Labeler code: 53329
Product ID: 53329-083_27d69435-782e-9b40-e063-6394a90a93f4
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Medline Industries, LP
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-01-01
Substance: SODIUM MONOFLUOROPHOSPHATE
Active strength: 1 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: SparkleFresh
Brand name suffix: Flouride Toothpaste
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	1 mg/g

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
1565528b-89f2-4c97-b294-15b6ebd3f80e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-083-21	SparkleFreshFlouride Toothpaste	42.5 g in 1 TUBE	PASTE, DENTIFRICE	42.5	7
53329-083-92	SparkleFreshFlouride Toothpaste	17 g in 1 PACKET	PASTE, DENTIFRICE	17	7
53329-083-93	SparkleFreshFlouride Toothpaste	24 g in 1 PACKET	PASTE, DENTIFRICE	24	7
53329-083-94	SparkleFreshFlouride Toothpaste	78 g in 1 TUBE	PASTE, DENTIFRICE	78	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Calcium Carbonate	INACTIVE INGREDIENT	H0G9379FGK	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Carboxymethylcellulose	INACTIVE INGREDIENT	05JZI7B19X	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Sodium Pyrophosphate	INACTIVE INGREDIENT	O352864B8Z	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-083	SPARKLEFRESH FLOURIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, LP]	7	Current NDC, Legacy NDC, 4 package rows	20250108_1565528b-89f2-4c97-b294-15b6ebd3f80e.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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Raspberry	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	57e1d1cb-da58-4cd2-b960-4056e0b0d214	2026-06-05	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaWhiteningToothpaste	SODIUM FLUORIDE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fb7dd-7f84-59c5-e063-6394a90accad	2026-06-02	Warnings	Exact identifier application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteeth	POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE	Hangzhou Namei Zhikang Technology Co., Ltd.	533fc83e-a8cf-15c1-e063-6294a90a7b74	2026-06-02	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	1565528b-89f2-4c97-b294-15b6ebd3f80e	7
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1565528b-89f2-4c97-b294-15b6ebd3f80e	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1565528b-89f2-4c97-b294-15b6ebd3f80e	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1565528b-89f2-4c97-b294-15b6ebd3f80e	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1565528b-89f2-4c97-b294-15b6ebd3f80e	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1565528b-89f2-4c97-b294-15b6ebd3f80e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-083-21	53329008321	42.5 g in 1 TUBE (53329-083-21)	42.5 g	2019-08-01	0000-00-00	No	No	Current
53329-083-92	53329008392	17 g in 1 PACKET (53329-083-92)	17 g	2019-08-01	0000-00-00	No	No	Current
53329-083-93	53329008393	24 g in 1 PACKET (53329-083-93)	24 g	2019-08-01	0000-00-00	No	No	Current
53329-083-94	53329008394	78 g in 1 TUBE (53329-083-94)	78 g	2019-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
083 SparkleFresh Fluoride Toothpaste	Medline Industries, LP	2024-11-26	HUMAN OTC DRUG LABEL	7
IIMED SparkleFresh Fluoride Toothpaste	IIMED MEDICAL MEXICANA S DE RL DE CV \| Team Technologies	2023-10-06	HUMAN OTC DRUG LABEL	1