Home NDC 58368-003 NeoRelief for Menstrual Pain and Cramps
Product NDC 58368-003
11-digit product format 583680003
Labeler code 58368
Product ID 58368-003_4960d9f7-cb96-b6e9-e063-6394a90a9a4d
Type HUMAN OTC DRUG
Nonproprietary name Homeopathic pain relief gel
Dosage form GEL
Route TOPICAL
Labeler BioLyte Laboratories, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-04-27
Substance APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CYCLAMEN PURPURASCENS TUBER; FRANGULA CALIFORNICA BARK; GELSEMIUM SEMPERVIRENS ROOT; JUNIPERUS SABINA LEAFY TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; POTASSIUM CARBONATE; SARACA INDICA BARK; SELENICEREUS GRANDIFLORUS STEM; TILIA X EUROPAEA FLOWER; VIBURNUM OPULUS BARK
Active strength 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 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
Pharmacologic classes Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base NeoRelief for Menstrual Pain and Cramps
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CARBONATE 4 [hp_X]/g FRANGULA CALIFORNICA BARK 4 [hp_X]/g ARNICA MONTANA 4 [hp_X]/g ATROPA BELLADONNA 4 [hp_X]/g BRYONIA ALBA ROOT 4 [hp_X]/g BLACK COHOSH 4 [hp_X]/g CYCLAMEN PURPURASCENS TUBER 4 [hp_X]/g SARACA INDICA BARK 4 [hp_X]/g LILIUM LANCIFOLIUM WHOLE FLOWERING 4 [hp_X]/g JUNIPERUS SABINA LEAFY TWIG 4 [hp_X]/g BELLIS PERENNIS 4 [hp_X]/g SELENICEREUS GRANDIFLORUS STEM 4 [hp_X]/g CAULOPHYLLUM THALICTROIDES ROOT 4 [hp_X]/g CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X]/g GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]/g VIBURNUM OPULUS BARK 4 [hp_X]/g TILIA X EUROPAEA FLOWER 4 [hp_X]/g APIS MELLIFERA 4 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 18 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58368-003-03 NeoRelief for Menstrual Pain and Cramps 1 in 1 CARTON GEL 1 9 58368-003-03 NeoRelief for Menstrual Pain and Cramps 14.17 g in 1 BOTTLE, PUMP GEL 14.17 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58368-003 NEORELIEF FOR MENSTRUAL PAIN AND CRAMPS (HOMEOPATHIC PAIN RELIEF GEL) GEL [BIOLYTE LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241012_71c2a2f7-4823-51cb-e053-2995a90a5fb8.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58368-003-03 58368000303 1 BOTTLE, PUMP in 1 CARTON (58368-003-03) / 14.17 g in 1 BOTTLE, PUMP 2018-04-27 0000-00-00 No No Current