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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	b9e6e455-8444-4805-89f1-ee9142f98e36	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	7db8e49d-1073-4a81-a3a4-f3a19ebce921	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	1fe50b49-bc62-4137-866c-e87bb878a96d	2026-08-10	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Radiant White	FLUORIDE	Lornamead Products	f0b62aaa-4983-4bd3-931e-f1a31b870f62	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Stain Prevention	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	76df52a3-b24c-4009-8137-fe644dabebf6	2026-07-29	Warnings	Exact identifier application number: M021
Colgate Kids Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	f0e68196-8566-443b-9cc8-b57d5c001558	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Vividly Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f0551acf-c4d6-4d49-ae9c-4aeaeb99a700	2026-07-29	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Whitening KnockOut Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	92079d13-3b66-42b7-9990-2727a489b6f6	2026-07-28	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	7d04d050-b283-4fce-b1e9-e695b70363f9	2026-07-27	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd805999-86e4-4f6c-9889-fa9a2227d526	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	913a2cd6-b6a8-4069-979f-3c696a9bfdf0	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PURPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	16e9b303-fc2a-451a-adc7-dcb10fc0e6f8	2026-07-23	Warnings	Exact identifier application number: M021
Orajel Kids Superman	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	2b47af33-32d4-7c06-e063-6394a90a2f33	2026-07-23	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