FDA.reportPublic FDA data

Genexa Arnica Pain

Manufacturer
Genexa Inc.
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:33:08

Label at a glance#

ProductGenexa Arnica Pain
Active ingredientTOXICODENDRON PUBESCENS LEAF, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, LEDUM PALUSTRE TWIG, RUTA GRAVEOLENS FLOWERING TOP
Label structure13 sections

Storage and handling

Other information store between 20-25° C (68-77° F) in a dry place out of direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients‡**

Arnica montana 30X HPUS

Calendula officinalis 6X HPUS

Ledum palustre 6X HPUS

Rhus toxicodendron 12X HPUS

Ruta graveolens 6X HPUS

‡ Organic

"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

trauma, muscle pain, muscle soreness, stiffness, swelling, bruising, strains and sprains

cuts, scrapes and discoloration from bruising

swelling, stiffness and bruising

joint pain, joint soreness and joint stiffness

muscle pain and muscle soreness

INDICATIONS & USAGE SECTION

Uses*

  • addresses muscle pain and stiffness due to minor injuries, overexertion and falls.
  • addresses pain, swelling and discoloration from bruises.

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctorif symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age and older
  • chew 2 tablets at the onset of symptoms
  • do not swallow whole
  • repeat every 4-6 hours as needed
children 3-11 years of age
  • chew 1 tablet at the onset of symptoms
  • do not swallow whole
  • repeat every 4-6 hours as needed
children under 3 years of ageask a doctor before use

STORAGE AND HANDLING SECTION

Other information

store between 20-25° C (68-77° F) in a dry place out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic carnauba wax, organic dextrose, grape flavor, organic maltodextrin, organic rice bran extract

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.

** X is a homeopathic dilution; see genexa.com/faq for more information.

SPL UNCLASSIFIED SECTION

Do not use if perforated band around the bottle or imprinted seal under the cap is broken or missing.

Patent Pending | Distributed by:

Genexa Inc. Atlanta, GA 30324

genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0044-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

Arnica Pain

Organic Pain Relief Formula*

Muscle Pain & Soreness*

Bruises & Swelling*

Joint Pain & Stiffness*

Made without: common allergens, artificial dyes, or parabens

Homeopathic

100 Chewable Tablets

Grape Flavor

6A Carton_R-202411216A Carton_R-20241121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0044-2Genexa Arnica Pain1 in 1 CARTONTABLET, CHEWABLE15
69676-0044-2Genexa Arnica Pain100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0044GENEXA ARNICA PAIN (ARNICA MONTANA, CALENDULA OFFICINALIS, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS) TABLET, CHEWABLE [GENEXA INC.]5Current NDC, Legacy NDC, 2 package rows20250406_b6fcbd3a-f5ba-e70d-e053-2995a90a8769.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-004469676-0044-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ARNICA MONTANAO80TY208ZWACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
CARNAUBA WAXR12CBM0EIZIACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
DEXTROSEIY9XDZ35W2IACT

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
Genexa Arnica PainARNICA MONTANA, CALENDULA OFFICINALIS, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENSGenexa Inc.b6fcbd3a-f5ba-e70d-e053-2995a90a87692025-04-02WarningsExact identifier
ndc (package): 69676-0044-2
ndc (product): 69676-0044
ndc11 (package): 69676004402
spl id: 31cb891e-55b9-73f0-e063-6294a90ad8e3
spl set id: b6fcbd3a-f5ba-e70d-e053-2995a90a8769

Reported adverse events (FAERS/openFDA)#

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