FDA.reportPublic FDA data

NEORELIEF FOR PAIN

Manufacturer
BioLyte Laboratories, LLC
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 02:36:53

Label at a glance#

ProductNEORELIEF FOR PAIN
Active ingredientBELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, CAULOPHYLLUM THALICTROIDES ROOT, CAUSTICUM, GUAIACUM OFFICINALE RESIN, HYPERICUM PERFORATUM, LITHIUM CARBONATE, FRANGULA CALIFORNICA BARK, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, HORSE CHESTNUT, SALICYLIC ACID, BLACK COHOSH, STELLARIA MEDIA, ACTAEA SPICATA ROOT, ALTHAEA OFFICINALIS ROOT, ARNICA MONTANA, ATROPA BELLADONNA ROOT, POTASSIUM CARBONATE, LEDUM PALUSTRE TWIG
Label structure14 sections

Indications and uses

For temporary relief of occasional: Minor aches and pains Stiffness of muscles, joints, and tissues Indications are based on homeopathic materia medica, not clinical tests.

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. Report all serious side effects to 800.538.1455

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

All active ingredients are HPUS* and 4X potency

Actaea, Aesculus Hipp., Belladonna, Bryonia., Caulophyllum, Causticum, Cimicifuga, Gauiacum, Hypericum, Kali Carb., Ledum, Lithium Carb., Rhamnus Calif., Rhododendron, Rhus. Tox., Ruta Grav., Salicylicum Ac., Setllaria Med.

Althaea

Arnica, Bellis, Calendula Pain Relief GelPain Relief Gel

Purpose

OTC - PURPOSE SECTION

Topical Analgesics

Anti-inflammatory

Relief of bruising and soreness

Uses

INDICATIONS & USAGE SECTION

For temporary relief of occasional:

Minor aches and pains

Stiffness of muscles, joints, and tissues

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

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 develeops

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 breatfeeding consult your doctor before use.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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.
  • Report all serious side effects to 800.538.1455

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

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 00501 5)

Drug Facts continued Peel Here

Packaging Recyclable

neorelief.com

BioLyte laboratories- Grand Rapids, MI 49534

NEORELIEF for PAIN 56.7g Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58368-005-01 Patented

NeoRelief

Pain

Temporary relief of minor aches and pains, and stiffness of muscles and joints

Homeopathic

pain relief gel

Net Wt. 2.0 oz (56.7g)

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58368-005-01NEORELIEF FOR PAIN1 in 1 CARTONGEL112
58368-005-01NEORELIEF FOR PAIN56.7 g in 1 BOTTLE, PUMPGEL56.712

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58368-00558368-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FULVIC ACIDXII14C5FXVIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BELLIS PERENNIS2HU33I03UYACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
CAUSTICUMDD5FO1WKFUACTIB
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
LITHIUM CARBONATE2BMD2GNA4VACTIB
FRANGULA CALIFORNICA BARK1LZ13MQR0SACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
BLACK COHOSHK73E24S6X9ACTIB
STELLARIA MEDIA2H03479QVRACTIB
ACTAEA SPICATA ROOT3FU86L9OS0ACTIB
ALTHAEA OFFICINALIS ROOTTRW2FUF47HACTIB
ARNICA MONTANAO80TY208ZWACTIB
ATROPA BELLADONNA ROOT6MW97Q6E8MACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB

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 PAINTOPICAL GEL FOR PAINBioLyte Laboratories, LLC46df076d-4e3a-6faa-e054-00144ff8d46c2026-01-27WarningsExact identifier
ndc (package): 58368-005-01
ndc (product): 58368-005
ndc11 (package): 58368000501
spl id: 4961467c-1d4d-20ce-e063-6394a90a2445
spl set id: 46df076d-4e3a-6faa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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