FDA.reportPublic FDA data

NeoRelief for Menstrual Pain and Cramps

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 Menstrual Pain and Cramps
Active ingredientPOTASSIUM CARBONATE, FRANGULA CALIFORNICA BARK, ARNICA MONTANA, ATROPA BELLADONNA, BRYONIA ALBA ROOT, BLACK COHOSH, CYCLAMEN PURPURASCENS TUBER, SARACA INDICA BARK, LILIUM LANCIFOLIUM WHOLE FLOWERING, JUNIPERUS SABINA LEAFY TWIG, BELLIS PERENNIS, SELENICEREUS GRANDIFLORUS STEM, CAULOPHYLLUM THALICTROIDES ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, GELSEMIUM SEMPERVIRENS ROOT, VIBURNUM OPULUS BARK, TILIA X EUROPAEA FLOWER, APIS MELLIFERA
Label structure13 sections

Indications and uses

For temporary relief of menstrual symptoms such as: Menstrual pain, Cramping Indications are based on homeopathic materia medica, not clinical tests.

Dosage and administration

Women ages 8 years and older, spread thin layer on lower abdomen and lower back. Do not apply over other topical lotions; they may hinder effectiveness. Apply as needed for relief.

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 actives are HPUS* and 4X potency.

Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina

Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum

Tilia

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

Purpose

OTC - PURPOSE SECTION

Topical Analgesics

Relief of Cramping

Anti-inflammatory

Uses

INDICATIONS & USAGE SECTION

For temporary relief of menstrual symptoms such as:

Menstrual pain, Cramping

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

Warnings

WARNINGS SECTION

For external use only

Do not use on damged 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding 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

Women ages 8 years and older, spread thin layer on lower abdomen and lower back.

Do not apply over other topical lotions; they may hinder effectiveness.

Apply as needed for relief.

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.

Reporty any serious side effects to the number above.

Addtional Label Content

SPL UNCLASSIFIED SECTION

Packaging Recyclable

Made in the USA

Listed with the FDA

neorelief.com

Drug Facts continued peel here

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

BioLyte Labs Grand Rapids, MI 49534

NEORELIEF for Menstrual Pain and Cramps

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58368-003-03 Patent Pending

Neo Relief

Temporary relief of

Menstrual pain & cramps

Homeopathic pain relief gel

Net Wt. 0.5 oz (14.17g)

NeoRelief_MensturalNeoRelief_Menstural

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58368-003-03NeoRelief for Menstrual Pain and Cramps1 in 1 CARTONGEL19
58368-003-03NeoRelief for Menstrual Pain and Cramps14.17 g in 1 BOTTLE, PUMPGEL14.179

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58368-00358368-003-03

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
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
FULVIC ACIDXII14C5FXVIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POTASSIUM CARBONATEBQN1B9B9HAACTIB
FRANGULA CALIFORNICA BARK1LZ13MQR0SACTIB
ARNICA MONTANAO80TY208ZWACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
BLACK COHOSHK73E24S6X9ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
SARACA INDICA BARK341ALE870WACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
BELLIS PERENNIS2HU33I03UYACTIB
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
TILIA X EUROPAEA FLOWERNHV2K1OUDHACTIB
APIS MELLIFERA7S82P3R43ZACTIB

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 Menstrual Pain and CrampsHOMEOPATHIC PAIN RELIEF GELBioLyte Laboratories, LLC71c2a2f7-4823-51cb-e053-2995a90a5fb82026-01-27WarningsExact identifier
ndc (package): 58368-003-03
ndc (product): 58368-003
ndc11 (package): 58368000303
spl id: 4960d9f7-cb96-b6e9-e063-6394a90a9a4d
spl set id: 71c2a2f7-4823-51cb-e053-2995a90a5fb8

Reported adverse events (FAERS/openFDA)#

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