Allday 5000 — v3

Allday 5000

8 Views

Version

v3

Effective date

September 23, 2025

Original packager

Yes

Sections captured

4

Identifiers

Document ID
3f7aeab7-532f-4ea4-e063-6294a90a6e76
Set ID
d92b84db-2202-33cc-e053-2a95a90a1753
Application numbers
—
Product NDCs
57511-0005
Package NDCs
57511-0005-1
Original packager NDCs
—

Names & Manufacturers

Brand names
Allday 5000
Generic names
1.1% SODIUM FLUORIDE TOOTHPASTE
Manufacturer names
Elevate Oral Care
Product types
HUMAN PRESCRIPTION DRUG

Substances & Pharmacology

Substance names
SODIUM FLUORIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
2602147, 392038
UNII
8ZYQ1474W7
UPC
—

Structured Label Sections

Instructions For Use (1)

Sequence 1

Instructions for Use Instructions for Use
Package Label Principal Display Panel (1)

Sequence 1

Primary Label Principal Display Label Primary Package Label
Spl Product Data Elements (1)

Sequence 1

Allday 5000 1.1% Sodium Fluoride Toothpaste SODIUM FLUORIDE FLUORIDE ION WATER HYDRATED SILICA DIMETHICONE PEG-8 ADIPATE SUCRALOSE XANTHAN GUM GLYCERIN XYLITOL SODIUM HYDROXIDE TITANIUM DIOXIDE white paste
Warnings (1)

Sequence 1

WARNINGS Warnings

OpenFDA raw payload

{'brand_name': ['Allday 5000'],
 'generic_name': ['1.1% SODIUM FLUORIDE TOOTHPASTE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Elevate Oral Care'],
 'package_ndc': ['57511-0005-1'],
 'product_ndc': ['57511-0005'],
 'product_type': ['HUMAN PRESCRIPTION DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['392038', '2602147'],
 'spl_id': ['3f7aeab7-532f-4ea4-e063-6294a90a6e76'],
 'spl_set_id': ['d92b84db-2202-33cc-e053-2a95a90a1753'],
 'substance_name': ['SODIUM FLUORIDE'],
 'unii': ['8ZYQ1474W7']}