FDA.reportPublic FDA data

ARNISPORT

Manufacturer
Hyland's Inc.
Effective date
2023-05-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:31:19

Label at a glance#

ProductARNISPORT
Active ingredientHYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP, LEDUM PALUSTRE TWIG, BELLIS PERENNIS, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERRUM PHOSPHORICUM, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, SILICON DIOXIDE, ARNICA MONTANA
Label structure8 sections

Indications and uses

■ Temporarily relieves symptoms of: ■ minor joint pain ■ bruising ■ muscle fatigue, swelling or soreness due to overexertion

Dosage and administration

Adults and children 12 years and over Dissolve 2–3 tablets under tongue every 4 hours. If the initial dosage is not providing relief, dissolve 2–3 tablets under tongue every 15 minutes, up to 6 doses. Children 6 years to under 12 years Dissolve 1–2 tablets under tongue every 4 hours. If the initial dosage is not providing relief, dissolve 1 tablet under tongue every 15 minutes, up to 6 doses.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 30X HPUS

Bellis Perennis 6X HPUS

Calcarea Fluorica 6X HPUS

Calcarea Phosphorica 3X HPUS

Calcarea Sulphurica 3X HPUS

Ferrum Phosphoricum 3X HPUS

Hypericum Perfoliatum 6X HPUS

Kali Muriaticum 3X HPUS

Kali Phosphoricum 3X HPUS

Kali Sulphuricum 3X HPUS

Ledum Palustre 6X HPUS

Magnesia Phosphorica 3X HPUS

Natrum Muriaticum 6X HPUS

Natrum Phosphoricum 3X HPUS

Natrum Sulphuricum 3X HPUS

Ruta Graveolens 6X HPUS

Silicea 6X HPUS

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

  • bruising, swelling, muscle soreness and pain
  • swelling and sore muscles
  • pain
  • pain in muscles
  • swelling
  • pain
  • shooting and radiating pains
  • swelling
  • pain
  • pain in limbs
  • pain
  • muscle soreness
  • minor pain in joints
  • muscle soreness
  • pain in muscles
  • pain
  • fatigue

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves symptoms of:
■ minor joint pain ■ bruising ■ muscle fatigue, swelling or soreness due to overexertion

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children
12 years and over 		Dissolve 2–3 tablets under tongue every 4 hours. If the initial
dosage is not providing relief, dissolve 2–3 tablets under
tongue every 15 minutes, up to 6 doses.
Children 6 years
to under 12 years 		Dissolve 1–2 tablets under tongue every 4 hours. If the initial
dosage is not providing relief, dissolve 1 tablet under
tongue every 15 minutes, up to 6 doses.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms persist for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

SPL UNCLASSIFIED SECTION

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Other information

OTHER SAFETY INFORMATION

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper0evident bottle cap band is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions?

OTC - QUESTIONS SECTION

(800) 624-9659

Indications and Usage

RECENT MAJOR CHANGES SECTION

Uses

  • Temporarily relieves the symptoms of:
  • muscle or minor joint pain 
  • bruising, swelling or soreness
  • fatigue due to overexertion

Dosage and Administration

RECENT MAJOR CHANGES SECTION

Directions

Adults and children

12 years and over

Dissolve 2–3 tablets under tongue every 4 hours. If the initial

dosage is not providing relief, dissolve 2–3 tablets under

tongue every 15 minutes, up to 6 doses.

Children 6 years

to under 12 years

Dissolve 1–2 tablets under tongue every 4 hours. If the initial

dosage is not providing relief, dissolve 1 tablet under

tongue every 15 minutes, up to 6 doses.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-0232-1

50 TABLETS

c@rtonc@rtonLabelLabel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
CALCIUM SULFATE ANHYDROUSACTIVE INGREDIENTE934B3V59H1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I101
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
POTASSIUM SULFATEACTIVE INGREDIENT1K573LC5TV1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587S1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4B1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z281
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CALCIUM FLUORIDEACTIVE MOIETYO3B55K4YKI1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587S1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-023254973-0232-1, 54973-0232-2, 54973-0232-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSEJ2B2A4N98GIACT
ACACIA5C5403N26OIACT
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
BELLIS PERENNIS2HU33I03UYACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB
FERRUM PHOSPHORICUM91GQH8I5F7ACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
POTASSIUM SULFATE1K573LC5TVACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
SODIUM SULFATE0YPR65R21JACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ARNICA MONTANAO80TY208ZWACTIB

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 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
051cad7e-a45d-dcac-e063-6394a90acfdb902b7f26-a136-4d50-a7ed-2d178d2e9df22023-09-11WarningsExact identifier
spl set id: 902b7f26-a136-4d50-a7ed-2d178d2e9df2

Reported adverse events (FAERS/openFDA)#

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