FDA.reportPublic FDA data

Sore Muscle and Joint Relief

Manufacturer
Vitaltiy Works, Inc. | Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:36:07

Label at a glance#

ProductSore Muscle and Joint Relief
Active ingredientARNICA MONTANA, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, POTASSIUM IODIDE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, LACTIC ACID, L-, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Sore Muscle & Joint Relief

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 30C                        Pulsatilla 30C

Bryona alba 30C                              Rhus toxicodendron 30C

Chamomilla 30C                               Sarcdolacticum acidum 30C

Kali iodatum 30C                              Zincum oxydatum 30C

Sore Muscle & Joint Relief

INACTIVE INGREDIENT SECTION

USP Vegetable Glycerin, USP Purified Water

Sore Muscle & Joint Relief

WARNINGS SECTION

If symtoms persist, discontinue use and consult a physician. If pregnant or nursing, consult physician before use.

Sore Muscle & Joint Relief

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Sore Muscle & Joint Relief

INDICATIONS & USAGE SECTION

For temporary relief of joint and muscle pains.

Sore Muscle & Joint Relief

DOSAGE & ADMINISTRATION SECTION

For age 6+, apply full dropper under tongue. Wait 20 seconds. Avoid food or beverages for 15 minutes.

Sore Muscle & Joint Relief

OTC - PURPOSE SECTION

Aids in relieving of pain from muscles and joints.

Sore Muscle & Joint Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130040232024979GTIN-13: 0040232024979
EAN-13: 0040232024979
GTIN-12: 040232024979
UPC-A: 040232024979
GTIN storage (14 digits): 00040232024979		Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-111-01Sore Muscle and Joint Relief30 mL in 1 BOTTLE, DROPPERLIQUID309

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B2
LACTIC ACID, L-ACTIVE INGREDIENTF9S9FFU82N2
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ2
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J2
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B2
IODIDE IONACTIVE MOIETY09G4I6V86Q2
LACTIC ACID, L-ACTIVE MOIETYF9S9FFU82N2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ2
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A2
ZINC CATIONACTIVE MOIETY13S1S8SF372
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-11164616-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
WATER059QF0KO0RIACT
POTASSIUM IODIDE1C4QK22F9JACTIM
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
LACTIC ACID, L-F9S9FFU82NACTIB
ZINC OXIDESOI2LOH54ZACTIM

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
ndc (package): 64616-111-01
ndc (product): 64616-111
ndc11 (package): 64616011101
spl id: 462f6bda-19e8-f9aa-e063-6394a90a75aa
spl set id: 3cd12d22-0fae-4a00-b026-c574e8035278

Reported adverse events (FAERS/openFDA)#

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