Home NDC 58368-002 NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
Product NDC 58368-002
11-digit product format 583680002
Labeler code 58368
Product ID 58368-002_4960b345-0a8e-7316-e063-6394a90abe8f
Type HUMAN OTC DRUG
Nonproprietary name topical gel for muscle cramping and restlessness
Dosage form GEL
Route TOPICAL
Labeler BioLyte Laboratories, LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-02-01
Substance ARNICA MONTANA; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA ROOT; BLACK COHOSH; CAUSTICUM; FRANGULA CALIFORNICA BARK; HYPERICUM PERFORATUM; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE; VALERIAN; VERATRUM ALBUM ROOT
Active strength 4; 8; 4; 4; 4; 4; 4; 8; 4; 4; 4; 4; 4; 4; 4; 4; 8; 8 [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 No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58368-002-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58368-002-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58368-002-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58368-002-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58368-002-02 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 58368-002-02 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58368-002-02 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58368-002-02 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58368-002-02 8dfbde2a14a4…c9ff85d89658…
Additional Listing Data#
Finished product Yes
Brand name base NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAUSTICUM 4 [hp_X]/g JATROPHA CURCAS SEED 8 [hp_X]/g FRANGULA CALIFORNICA BARK 4 [hp_X]/g RUTA GRAVEOLENS FLOWERING TOP 4 [hp_X]/g ARNICA MONTANA 4 [hp_X]/g ATROPA BELLADONNA ROOT 4 [hp_X]/g BLACK COHOSH 4 [hp_X]/g ARTEMISIA CINA PRE-FLOWERING TOP 8 [hp_X]/g PSEUDOGNAPHALIUM OBTUSIFOLIUM 4 [hp_X]/g HYPERICUM PERFORATUM 4 [hp_X]/g STRYCHNOS IGNATII SEED 4 [hp_X]/g POTASSIUM BROMIDE 4 [hp_X]/g POTASSIUM CARBONATE 4 [hp_X]/g LYCOPODIUM CLAVATUM SPORE 4 [hp_X]/g SCUTELLARIA LATERIFLORA 4 [hp_X]/g TARAXACUM OFFICINALE 4 [hp_X]/g VALERIAN 8 [hp_X]/g VERATRUM ALBUM ROOT 8 [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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58368-002-02 NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS 56.7 g in 1 BOTTLE, PUMP GEL 56.7 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58368-002 NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS) GEL [BIOLYTE LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20241018_46da3f0e-9dd1-6495-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 Units Marketing start Sample Exclude flag Status 58368-002-02 58368000202 56.7 g in 1 BOTTLE, PUMP (58368-002-02) 56.7 g 2017-02-01 No No Current