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 38 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	290c57b0-a562-0a51-e063-6294a90a0720	2025-06-23	Warnings	Exact identifier application number: M021
KarlnHans Fresh Breath Jasmine Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	384863bd-b2cb-a46d-e063-6394a90a3ce2	2025-06-23	Warnings	Exact identifier application number: M021
KarlnHans Fresh Breath Double Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	38487130-9508-a2c4-e063-6394a90aa323	2025-06-23	Warnings	Exact identifier application number: M021
Crest Kids SparkleFun Bubblegum	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	01f0e81a-03bf-e17f-e063-6394a90a7358	2025-06-12	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	2ee626d1-6150-87db-e063-6294a90a64d8	2025-06-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh Citrus Fresh	SODIUM FLUORIDE	Colgate-Palmolive Company	13a74642-51d2-493c-ae97-a54508546a74	2025-06-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh Watermelon Blast	SODIUM FLUORIDE	Colgate-Palmolive Company	4f07f945-6594-40f4-bc19-6acc12c37cdd	2025-06-12	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	36994628-e5f3-3c35-e063-6294a90a609d	2025-06-02	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35bfa3fc-106e-aecc-e063-6294a90a7eb0	2025-05-22	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	369aa02f-c312-6a0d-e063-6294a90adaa5	2025-05-22	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING TRAVEL	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	3596306e-858c-9bf7-e063-6294a90ac1d6	2025-05-20	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	3582cc91-8c32-9f93-e063-6394a90a8792	2025-05-19	Warnings	Exact identifier application number: M021
EUTHYMOL WHITENING SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35839b10-4c40-40e5-e063-6294a90a85b4	2025-05-19	Warnings	Exact identifier application number: M021
Hello Unicorn Sparkle	SODIUM FLUORIDE	Colgate-Palmolive Company	5acfbd9b-278c-24dd-8041-5e2cdffbf710	2025-05-13	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Cotton Candy	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	25f182cb-ad1e-4c13-bc79-1ec251754cf8	2025-05-12	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Watermelon	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	b506df13-649f-4615-bc25-6ae08bd56b18	2025-05-12	Warnings	Exact identifier application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	346daeae-7590-176c-e063-6294a90a52ea	2025-05-05	Warnings	Exact identifier application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	3de0d71a-7704-97dd-e063-6294a90a5d2c	2025-05-01	Warnings	Exact identifier application number: M021
Brush Buddies Value 2 pack Whitening	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc	636bf51d-9750-4305-ab4a-3483c9f0169b	2025-04-30	Warnings	Exact identifier application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope	SODIUM FLUORIDE	Navajo Manufacturing Company Inc	3adb1524-0fd6-4728-b757-dcbda4cdd0fb	2025-04-29	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