FDA.reportPublic FDA data

T-Relief Extra Strength

Manufacturer
MediNatura Inc
Effective date
2023-09-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:22:25

Label at a glance#

ProductT-Relief Extra Strength
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT, ACONITUM NAPELLUS, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM
Label structure8 sections

Indications and uses

Uses For the temporary relief of minor: Muscular Pain, Joint Pain, Back Pain, Nerve Pain and Arthritis Pain.

Dosage and administration

Adults and children 12 years and older: 10 drops every 4 hours either under the tongue for MAX absorption or add to a cup of water and drink. Not exceed 60 drops per 24 hours. For children under 12 years: Consult your health professional.

Label contents#

Full prescribing information#

WARNINGS

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted . Do not use if known sensitivity to T-Relief TM or any of its ingredients exists.

USES

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor: Muscular Pain, Joint Pain, Back Pain, Nerve Pain and Arthritis Pain.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If symptoms persist or worsen, a health professional should be consulted .

PURPOSE

OTC - PURPOSE SECTION

Relieves

• Joint Pain

• Back Pain

• Muscular Pain

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: 10 drops every 4 hours either under the tongue for MAX absorption or add to a cup of water and drink. Not exceed 60 drops per 24 hours. For children under 12 years: Consult your health professional.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Ethanol, Purified water

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Each 50mL contains: *Arnica montana 3X 42%,
Wild-Harvested Baptisia tinctoria 2X 9%, *Aconitum napellus 3X 7.5%,
*Symphytum officinale 8X 7.5%, Organic Millefolium 2X 6%, *Ruta
graveolens 3X 4%, *Arnica montana 4X 3.6%, *Arnica montana 8X 3.6%,
*Bellis perennis 2X 3%, Organic Calendula officinalis 2X 3%, Organic
Echinacea 2X 3%, *Hamamelis virginiana 2X 3%, *Hypericum perforatum
3X 3%, *Belladonna 3X 0.9%, Organic Chamomilla 2X 0.9%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

T-Relief Extra Strength.jpgT-Relief Extra Strength.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-2010-4T-Relief Extra Strength50 mL in 1 BOTTLESOLUTION/ DROPS504
62795-2010-4T-Relief Extra Strength1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-2010T-RELIEF EXTRA STRENGTH (CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT, ACONITUM NAPELLUS, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, ARNICA MONTANA, BELLIS PERENNIS AND HYPERICUM PERFORATUM) SOLUTION/ DROPS [MEDINATURA INC]4Current NDC, Legacy NDC, 2 package rows20231004_01804104-32c2-4011-a2e4-0f4e74bd974d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-2010-4ML - Milliliter62795-201095945222-ea6a-40a5-995f-8dcb9aa6282012022-05-04

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-201062795-2010-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
COMFREY ROOTM9VVZ08EKQACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ARNICA MONTANAO80TY208ZWACTIB
BELLIS PERENNIS2HU33I03UYACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-Relief Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, COMFREY ROOT, ACONITUM NAPELLUS, ECHINACEA, UNSPECIFIED, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, ARNICA MONTANA, BELLIS PERENNIS AND HYPERICUM PERFORATUMMediNatura Inc01804104-32c2-4011-a2e4-0f4e74bd974d2023-09-28WarningsExact identifier
ndc (package): 62795-2010-4
ndc (product): 62795-2010
ndc11 (package): 62795201004
spl id: b7adba46-235d-4d94-9184-fe03eaf54102
spl set id: 01804104-32c2-4011-a2e4-0f4e74bd974d

Reported adverse events (FAERS/openFDA)#

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