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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	3bba340e-2a62-3b04-41b5-0ed9c13adb13	2026-04-22	Warnings	Exact identifier application number: M021
EverSmile Squirt	SODIUM FLUORIDE 0.05%	Everbrands, Inc.	bc0ef174-2909-469a-b629-0eab4412bdfc	2026-04-20	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Walmart	41d6cc7a-0b87-e474-e063-6294a90ae995	2026-04-20	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf	2026-04-19	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	H E B	8d40f693-083c-4eb6-9da1-42675d757e0e	2026-04-16	Warnings, Adverse reactions	Exact identifier application number: M021
Eversmile OrthoFoam Anticavity	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	9c12e792-94c8-4e29-9a54-e7e70aadade6	2026-04-16	Warnings	Exact identifier application number: M021
Eversmile Squirt	2.65% HYDROGEN PEROXIDE	Everbrands, Inc.	6753b426-6d49-4438-a52f-c28e60a0e9d8	2026-04-16	Warnings	Exact identifier application number: M021
Osstem G Gum Health Care Tooth	SODIUM FLUORIDE	Osstem Pharma Co., Ltd	4f8b4fc0-4c98-5e52-e063-6394a90af710	2026-04-15	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Enamel Strength	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	4f6b8851-c778-8abd-e063-6294a90aef4f	2026-04-14		Exact identifier application number: M021
Crest 3D White Stain Eraser Luxe Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6beb3b-2521-bfb7-e063-6394a90ad9ea	2026-04-14		Exact identifier application number: M021
Kids Crest Strawberry Rush	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6d11b2-5aa2-ab34-e063-6294a90ac0bc	2026-04-14	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Publix Super Markets, Inc.	cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	f0e84078-499f-4a5a-bcd2-23f57805de86	2026-04-14	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Pro-Health Advanced Multi-Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	1cfc5b61-c8e5-943d-e063-6394a90a890b	2026-04-14	Warnings	Exact identifier application number: M021
Crest Pro-Health Multi-Protection plus Extra Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f6f6299-f95f-2f0e-e063-6294a90a1641	2026-04-14	Warnings	Exact identifier application number: M021
Crest 3D White Strength Whitening Enamel Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	4f7125aa-3aa2-ca64-e063-6394a90a4cf3	2026-04-14	Warnings	Exact identifier application number: M021
Eversmile TheraFoam	0.05% SODIUM FLUORIDE RINSE	Everbrands, Inc.	57da2479-923a-45ec-8149-57b469b11637	2026-04-13	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Bacteria Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	4f1ce508-fe6e-4045-e063-6294a90ab3e2	2026-04-10	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Relief	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	4f1d62ae-653e-3046-e063-6294a90abbf8	2026-04-10	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