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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freshen Up chai latte mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52e364f9-113a-df4e-e063-6294a90a263b	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5257c409-d379-8c48-e063-6294a90acda9	2026-07-14	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	52bbc6d9-17ab-851a-e063-6394a90ab4bf	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	MKJ BRANDS LLC	5259bc45-85da-b17b-e063-6294a90a7919	2026-07-14	Warnings	Exact identifier application number: M021
Colgate Optic White Advanced Icy Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f95496e3-11ec-4cd6-b3ee-cf6c657b790b	2026-07-13	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	7f240d1d-ea3d-42b1-a4b0-106c58707452	2026-07-08	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	2f24a9eb-7a89-30e1-e063-6394a90a032b	2026-07-08		Exact identifier application number: M021
Dr. Noah Kids Tooth	SODIUM MONOFLUOROPHOSPHATE	Project Noah Inc.	562311aa-9ac5-00c2-e063-6394a90a67a7	2026-07-08	Warnings	Exact identifier application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	263fef13-347b-489b-987d-933a63dbc900	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Triple Action	SODIUM FLUORIDE	Colgate-Palmolive Company	3082e9ba-66d9-4fc7-bbe6-b41b60939bd2	2026-07-08	Warnings	Exact identifier application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	f464cecb-e876-4057-ab5c-94de747434db	2026-07-08	Warnings	Exact identifier application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty Fresh	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	560815d6-018a-0c24-e063-6394a90a1071	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ecfbed-ba99-11eb-e063-6294a90ae64d	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash striped	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	56091601-74dd-0a3b-e063-6394a90af476	2026-07-07	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Outlast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	55054217-f21b-1c41-e063-6394a90ae40b	2026-07-07	Warnings	Exact identifier application number: M021
Hello Dragon Dazzle Dragon Dazzle Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	eaca1ad1-9e31-b904-4148-247ad2460661	2026-07-07	Warnings	Exact identifier application number: M021
Colgate Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	cdd2ad04-8c65-40f2-b323-5ce11af52e4f	2026-07-06	Warnings	Exact identifier application number: M021
AIM Cavity Protection with Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	a8c742e1-ee61-4593-b8f5-b9e586d39dfc	2026-07-01	Warnings	Exact identifier application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINT	SODIUM FLUORIDE	Tom's of Maine	6f825520-0f8a-4b4c-bbb6-987f64ab8769	2026-07-01	Warnings	Exact identifier application number: M021
Colgate Deep Clean Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	47e8e943-f4d5-40bc-8f79-ec9ea06125de	2026-07-01	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