SparkleFresh

Manufacturer: Medline Industries, LP
Effective date: 2024-11-26
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:50:50

Label at a glance#

ProductSparkleFresh Flouride Toothpaste

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure8 sections

Dosage and administration

adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 2 years of age: consult a dentist or physician

Contacts and useful links#

Websitewww.medline.com

www.medline.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician
instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
supervise children as necessary until capable of using without supervision
children under 2 years of age: consult a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, ﬂavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.medline.com

1-800-MEDLINE (633-5463)

REF: NONTP15I

RH22NWI

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label RH22NWI

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	7
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	7
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	7

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 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Calcium Carbonate	INACTIVE INGREDIENT	H0G9379FGK	1
Carboxymethylcellulose	INACTIVE INGREDIENT	05JZI7B19X	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sodium Pyrophosphate	INACTIVE INGREDIENT	O352864B8Z	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

SparkleFresh Flouride Toothpaste
Sodium Monofluorophosphate
WATER
FLUORIDE ION
METHYLPARABEN
SODIUM SILICATE
SACCHARIN SODIUM
SACCHARIN
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
PROPYLPARABEN
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
CALCIUM CARBONATE
SODIUM LAURYL SULFATE
SORBITOL
SODIUM PYROPHOSPHATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-083	53329-083-21, 53329-083-92, 53329-083-93, 53329-083-94

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
METHYLPARABEN	A2I8C7HI9T	IACT
SODIUM SILICATE	IJF18F77L3	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SORBITOL	506T60A25R	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 70 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Match
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg	Exact identifier — unii+route 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	JELLY / VAGINAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	POWDER, FOR SUSPENSION / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	POWDER, FOR SUSPENSION / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET, DELAYED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	CAPSULE, EXTENDED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	CAPSULE, EXTENDED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg	Exact identifier — unii+route 5 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	JELLY / VAGINAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	JELLY / VAGINAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg	Exact identifier — unii+route 5 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	JELLY / VAGINAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET, DELAYED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	CAPSULE, EXTENDED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	CAPSULE, EXTENDED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	INJECTION / INTRAMUSCULAR	5 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg	Exact identifier — unii+route 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET, DELAYED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	POWDER, FOR SUSPENSION / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET, DELAYED RELEASE / ORAL	NA	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml	Exact identifier — unii candidate 40 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	TABLET / ORAL	45 mg	Exact identifier — unii candidate 40 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SparkleFresh Flouride Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Medline Industries, LP	1565528b-89f2-4c97-b294-15b6ebd3f80e	2024-11-26	Warnings	Exact identifier ndc (package): 53329-083-92 ndc (package): 53329-083-93 ndc (package): 53329-083-21 ndc (package): 53329-083-94 ndc (product): 53329-083 ndc11 (package): 53329008321 ndc11 (package): 53329008392 ndc11 (package): 53329008393 ndc11 (package): 53329008394 spl id: 27d69435-782e-9b40-e063-6394a90a93f4 spl set id: 1565528b-89f2-4c97-b294-15b6ebd3f80e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.