NDC 58368-003

NeoRelief for Menstrual Pain and Cramps

Homeopathic Pain Relief Gel

NeoRelief for Menstrual Pain and Cramps is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Biolyte Laboratories, Llc. The primary component is Potassium 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.

• Product ID: 58368-003_7e092c3d-c694-aca7-e053-2991aa0a837d
• NDC: 58368-003
• Product Type: Human Otc Drug
• Proprietary Name: NeoRelief for Menstrual Pain and Cramps
• Generic Name: Homeopathic Pain Relief Gel
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-04-27
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: BioLyte Laboratories, LLC
• Substance Name: POTASSIUM 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
• Active Ingredient Strength: 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58368-003-03

1 BOTTLE, PUMP in 1 CARTON (58368-003-03) > 14.17 g in 1 BOTTLE, PUMP

• Marketing Start Date: 2018-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58368-003-03 [58368000303]

NeoRelief for Menstrual Pain and Cramps GEL

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-04-27

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM CARBONATE	4 [hp_X]/g

OpenFDA Data

• SPL SET ID: 71c2a2f7-4823-51cb-e053-2995a90a5fb8
• Manufacturer:
  • BioLyte Laboratories, LLC
• UNII:
  • 341ALE870W
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  • 1LZ13MQR0S
  • WQZ3G9PF0H
  • 2HU33I03UY
  • 7114SV0MYK
  • X67Z2963PI
  • T1UG6H6805
  • BQN1B9B9HA
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  • NHV2K1OUDH
  • 7S82P3R43Z