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NDC 57511-0005-01 Allday 5000 1.1 g/100g Details

Allday 5000 1.1 g/100g

Allday 5000 is a TOPICAL PASTE, DENTIFRICE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Elevate Oral Care. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 57511-0005-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	57511-0005
Product ID	57511-0005_d92b84db-2203-33cc-e053-2a95a90a1753
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Allday 5000
Proprietary Name Suffix	n/a
Non-Proprietary Name	1.1% Sodium Fluoride Toothpaste
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	PASTE, DENTIFRICE
Route	TOPICAL
Active Ingredient Strength	1.1
Active Ingredient Units	g/100g
Substance Name	SODIUM FLUORIDE
Labeler Name	Elevate Oral Care
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 57511-0005-01 (57511000501)

Pricing Information	N/A
NDC Package Code	57511-0005-1
Billing NDC	57511000501
Package	2 TUBE in 1 BOX (57511-0005-1) / 1 g in 1 TUBE
Marketing Start Date	2022-05-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d92b84db-2202-33cc-e053-2a95a90a1753 Details

WARNINGS

WARNINGS: Not for systemic treatment. DO NOT SWALLOW. Keep out of reach of children under 6 years of age.

Instructions for Use

Package Label

INGREDIENTS AND APPEARANCE

ALLDAY 5000

1.1% sodium fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:57511-0005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIMETHICONE PEG-8 ADIPATE (UNII: 09Y0SJ39VP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white paste)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57511-0005-1	2 in 1 BOX	05/31/2022
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/31/2022

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Name	Address	ID/FEI	Business Operations
Establishment
Elevate Oral Care		002863526	manufacture(57511-0005)

Revised: 3/2022

Document Id: d92b84db-2203-33cc-e053-2a95a90a1753

Set id: d92b84db-2202-33cc-e053-2a95a90a1753

Version: 1

Effective Time: 20220301