Home NDC 58368-005 NEORELIEF FOR PAIN
Product NDC 58368-005
11-digit product format 583680005
Labeler code 58368
Product ID 58368-005_4961467c-1d4d-20ce-e063-6394a90a2445
Type HUMAN OTC DRUG
Nonproprietary name topical gel for pain
Dosage form GEL
Route TOPICAL
Labeler BioLyte Laboratories, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-02-01
Substance ACTAEA SPICATA ROOT; ALTHAEA OFFICINALIS ROOT; ARNICA MONTANA; ATROPA BELLADONNA ROOT; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; FRANGULA CALIFORNICA BARK; GUAIACUM OFFICINALE RESIN; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; POTASSIUM CARBONATE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; STELLARIA MEDIA; TOXICODENDRON PUBESCENS LEAF
Active strength 4; 4; 4; 4; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes Mood Stabilizer [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 PAIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BELLIS PERENNIS 4 [hp_X]/g BRYONIA ALBA ROOT 4 [hp_X]/g CALENDULA OFFICINALIS FLOWERING TOP 4 [hp_X]/g CAULOPHYLLUM THALICTROIDES ROOT 4 [hp_X]/g CAUSTICUM 4 [hp_X]/g GUAIACUM OFFICINALE RESIN 4 [hp_X]/g HYPERICUM PERFORATUM 4 [hp_X]/g LITHIUM CARBONATE 4 [hp_X]/g FRANGULA CALIFORNICA BARK 4 [hp_X]/g RHODODENDRON AUREUM LEAF 4 [hp_X]/g TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP 4 [hp_X]/g HORSE CHESTNUT 4 [hp_X]/g SALICYLIC ACID 4 [hp_X]/g BLACK COHOSH 4 [hp_X]/g STELLARIA MEDIA 4 [hp_X]/g ACTAEA SPICATA ROOT 4 [hp_X]/g ALTHAEA OFFICINALIS ROOT 4 [hp_X]/g ARNICA MONTANA 4 [hp_X]/g ATROPA BELLADONNA ROOT 4 [hp_X]/g POTASSIUM CARBONATE 4 [hp_X]/g LEDUM PALUSTRE TWIG 4 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 22 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58368-005-01 NEORELIEF FOR PAIN 1 in 1 CARTON GEL 1 12 58368-005-01 NEORELIEF FOR PAIN 56.7 g in 1 BOTTLE, PUMP GEL 56.7 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58368-005 NEORELIEF FOR PAIN (TOPICAL GEL FOR PAIN) GEL [BIOLYTE LABORATORIES, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241010_46df076d-4e3a-6faa-e054-00144ff8d46c.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 58368-005-01 58368000501 1 BOTTLE, PUMP in 1 CARTON (58368-005-01) / 56.7 g in 1 BOTTLE, PUMP 2017-02-01 0000-00-00 No No Current