NEUTRAMAXX 5000 TCP

Manufacturer: Massco Dental A Division of Dunagin Pharmaceuticals
Effective date: 2023-12-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 20:56:37

Label at a glance#

ProductNEUTRAMAXX 5000 TCP

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Indications and uses

NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Dosage and administration

This prescription dentifrice is recommended for adults and pediatric patients 6 years and older Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. After brushing ADULTS - Expectorate, do not eat for 30 minutes. CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water. Use at bedtime in place of your regul...

Contacts and useful links#

PhoneLabel contact1-479-787-5168

Websitewww.masscodental.net

www.masscodental.net

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS ACTIVE INGREDIENT 1.1 % NEUTRAL SODIUM FLUORIDE

Purpose Section

OTC - PURPOSE SECTION

For prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Keep Out of Reach of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with all medications, keep out of reach of children.

Indications and Usage Section

INDICATIONS & USAGE SECTION

NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Warning Section

WARNINGS SECTION

Warnings Do not swallow For topical use only

Directions: Use As Directed Section

DOSAGE & ADMINISTRATION SECTION

This prescription dentifrice is recommended for adults and pediatric patients 6 years and older

Apply a thin ribbon of NeutraMaxxtm 5000 TCP along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes.

After brushing ADULTS - Expectorate, do not eat for 30 minutes. CHILDREN 6 YEARS OF AGE OR OLDER - Expectorate and rinse mouth with water. Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

Inactive Ingredient Section

Inactive Ingredients: Deionized Water, Sorbitol, Hydrated Silica, PEG, Carboxymethylcellulose, Xylitol, MonoSodium Phosphate, Titanium Dioxide, Mint Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Questions? Comments? Section

OTC - QUESTIONS SECTION

Call 1-479-787-5168 M-F 9am to 5 pm CST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REFRESHING MINT FLAVOR RELIEVES SENSITIVITY

ANTI-CAVITY TOOTHPASTE NeutraMaxx tm 5000 TCP XYLITO1.1% Neutral Sodium Fluoride 5000 ppm Sweetened with Xylitol

DOES NOT CONTAIN SODIUM LAURYL SULFATE RX ONLY Net wt. 4 oz (112 G)

Manufactured By: MASSCO DENTAL A Division of Dunagin Pharmaceuticals, Gravette, AR (479) 787-5168 www.masscodental.net

Massco__TCP1_label

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1191716	NeutraMaxx 500 Plus Turbo 1.1 % Dental Gel	PSN	7
392038	sodium fluoride 1.1 % Toothpaste	PSN	7
1191716	sodium fluoride 0.011 MG/MG Toothpaste [Neutramaxx]	SBD	7
392038	sodium fluoride 0.011 MG/MG Toothpaste	SCD	7
1191716	Neutramaxx 0.011 MG/MG Dental Gel	SY	7
1191716	Neutramaxx 1.1 % Dental Gel	SY	7
392038	sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste	SY	7
392038	sodium fluoride 1.1 % Dental Gel	SY	7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63783-501-04	NEUTRAMAXX 5000 TCP	112 g in 1 TUBE	PASTE, DENTIFRICE	112		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63783-501	NEUTRAMAXX 5000 TCP (SODIUM FLUORIDE) PASTE, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]	7	Current NDC, Legacy NDC, 1 package rows	20231218_f47cb584-eb8a-4297-ba32-5f435e85aacb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	2
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	2
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	2
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NEUTRAMAXX 5000 TCP
SODIUM FLUORIDE
FLUORIDE ION
WATER
SORBITOL
HYDRATED SILICA
POLYETHYLENE GLYCOL 8000
CARBOXYMETHYLCELLULOSE
XYLITOL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TITANIUM DIOXIDE
SACCHARIN SODIUM
TRIBASIC CALCIUM PHOSPHATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63783-501	63783-501-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
XYLITOL	VCQ006KQ1E	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	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 4 · 206 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL		104 mg	Exact identifier — unii+route 16 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	CAPSULE / ORAL	600 mg		Exact identifier — unii+route 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET / ORAL		330 mg	Exact identifier — unii+route 16 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii+route 22 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii+route 38 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii+route 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+dosage form 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii+route 46 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	CAPSULE / ORAL		180 mg	Exact identifier — unii+route 22 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET, EXTENDED RELEASE / ORAL		750 mg	Exact identifier — unii+route 16 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii+route 38 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii+route 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	CAPSULE / ORAL		176 mg	Exact identifier — unii+route 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii+route 46 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+dosage form 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii+route 46 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET, EXTENDED RELEASE / ORAL		242 mg	Exact identifier — unii+route 22 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	SUSPENSION / ORAL	50.07 mg/5ml		Exact identifier — unii+route 12 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route 46 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii+route 38 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET / ORAL	31.72 mg		Exact identifier — unii+route 16 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii+route 38 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET, DELAYED RELEASE / ORAL		29 mg	Exact identifier — unii+route 22 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET, FILM COATED / ORAL	21.8 mg		Exact identifier — unii+route 16 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATE	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii+route 20 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii+route 20 equally ranked IID candidates
TRIBASIC CALCIUM PHOSPHATE	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	CAPSULE, EXTENDED RELEASE / ORAL	32.73 mg		Exact identifier — unii+route 16 equally ranked IID candidates
POLYETHYLENE GLYCOL 8000	POLYETHYLENE GLYCOL 8000	Q662QK8M3B	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route 46 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / ORAL		1500 mg	Exact identifier — unii+route 16 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 38 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
NEUTRAMAXX 5000 TCP	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	f47cb584-eb8a-4297-ba32-5f435e85aacb	2023-12-17	Warnings	Exact identifier ndc (package): 63783-501-04 ndc (product): 63783-501 ndc11 (package): 63783050104 spl id: 22fb5942-a2d6-4f0e-8064-a6012e05f43b spl set id: f47cb584-eb8a-4297-ba32-5f435e85aacb

Reported adverse events (FAERS/openFDA)#

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