FDA.reportPublic FDA data

NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS

Manufacturer
BioLyte Laboratories, LLC
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:36:53

Label at a glance#

ProductNEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
Active ingredientCAUSTICUM, JATROPHA CURCAS SEED, FRANGULA CALIFORNICA BARK, RUTA GRAVEOLENS FLOWERING TOP, ARNICA MONTANA, ATROPA BELLADONNA ROOT, BLACK COHOSH, ARTEMISIA CINA PRE-FLOWERING TOP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, POTASSIUM BROMIDE, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, SCUTELLARIA LATERIFLORA, TARAXACUM OFFICINALE, VALERIAN, VERATRUM ALBUM ROOT
Label structure14 sections

Indications and uses

For temporary relief of occasional muscle cramps, restlessness and twitching

Dosage and administration

Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area. For best results, allow gel to be absorbed into the skin; do not rub in. Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour. Do not use with other topical remedies or lotions.

Storage and handling

Store in a cool, dry place Avoid direct sunlight Tamper-evident for your protection. Use only if safety seal is intact.

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

All active ingredients are HPUS*

Arncia 4X, Causticum 4X, Rhamnus Calif. 4X, Ruta 4X, Taraxacum 4X,

Belladonna 4X, Cimicifuga 4X, Gnaphalium 4X, Hypericum Perf. 4X, Jatropha 8X, Veratrum 8X

Cina 8X, Ignatia 4X, Kali Brom. 4X, Kali Carb. 4X, Lycopodium 4X, Scutellaria 4X, Valeriana Off. 4X

*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

NeoRelief Muscle CrampNeoRelief Muscle Cramp

Purpose

OTC - PURPOSE SECTION

For the temporary relief of occasional:

Muscle cramps, restlessness, twiching

Indications are based on homeopathic materia medica, not clinical tests.

Uses

INDICATIONS & USAGE SECTION

For temporary relief of occasional muscle cramps, restlessness and twitching

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin.

Keep out of eyes, open wounds, mucous membranes

Warnings

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop use and ask doctor if condition worsens or persists, rash develops

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, consult your doctor before use.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.

For best results, allow gel to be absorbed into the skin; do not rub in.

Apply at the onset of symptoms, not more than 6 times daily or every 15 minutes for the first hour.

Do not use with other topical remedies or lotions.

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place

Avoid direct sunlight

Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Fulvic acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer

Questions or comments?

OTC - QUESTIONS SECTION

800.538.1455

Monday through Friday 8 a.m. - 5 p.m. EST or visit us at neorelief.com

Report serious side effects to 800.538.1455

Additional Label Content

SPL UNCLASSIFIED SECTION

Required FTC Disclosure: Product efficacy and claims are based on theories of homeopathy that are not supported by scientific evidence and most modern allopathic medical professionals.

Made in the USA

Listed with the FDA

(UPC code: 3 58368 00202 1)

Drug Facts continued peel here

Packaging Recyclable

neorelief.com

BioLyte Laboratories- Grand Rapids, MI 49534

NEORELIEF for Muscle Cramping and Restlessness 56.7 g Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58368-002-02 Patent pending

NeoRelief

Temporary relief of muscle cramping and restlessness

Homeopathic muscle calming and pain relief gel

Net Wt. 2.0 oz (56.7g) Muscle Cramp and RestlessnessMuscle Cramp and Restlessness

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58368-002-022024-10-16C16284748780-1ba0f9c33-562a-a910-e053-dadaa90a0b8546da3f0e-9dd1-6495-e054-00144ff8d46c
58368-002-022021-01-29C16284748780-1ba0f9c33-562a-a910-e053-dadaa90a0b8546da3f0e-9dd1-6495-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58368-002-02NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS56.7 g in 1 BOTTLE, PUMPGEL56.79

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58368-00258368-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FULVIC ACIDXII14C5FXVIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CAUSTICUMDD5FO1WKFUACTIB
JATROPHA CURCAS SEEDJ0F5GM8LA8ACTIB
FRANGULA CALIFORNICA BARK1LZ13MQR0SACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
ARNICA MONTANAO80TY208ZWACTIB
ATROPA BELLADONNA ROOT6MW97Q6E8MACTIB
BLACK COHOSHK73E24S6X9ACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM36XQ854NWWACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SCUTELLARIA LATERIFLORA7BP4DH5PDCACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
VALERIANJWF5YAW3QWACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB

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
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESSTOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESSBioLyte Laboratories, LLC46da3f0e-9dd1-6495-e054-00144ff8d46c2026-01-27WarningsExact identifier
ndc (package): 58368-002-02
ndc (product): 58368-002
ndc11 (package): 58368000202
spl id: 4960b345-0a8e-7316-e063-6394a90abe8f
spl set id: 46da3f0e-9dd1-6495-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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