Home NDC 61594-046 Theraworx Relief for Muscle Cramps Roll-On
Product NDC 61594-046
11-digit product format 615940046
Labeler code 61594
Product ID 61594-046_2308de12-a4fa-d1f3-e063-6394a90a3ca1
Type HUMAN OTC DRUG
Nonproprietary name MAGNESIUM SULFATE, UNSPECIFIED FORM
Dosage form AEROSOL
Route TOPICAL
Labeler AVADIM HOLDINGS, INC.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2025-01-01
Substance MAGNESIUM SULFATE, UNSPECIFIED FORM
Active strength 6 [hp_X]/mL
Pharmacologic classes Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Theraworx Relief for Muscle Cramps Roll-On
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE, UNSPECIFIED FORM 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DE08037SAB Internal UNII lookup
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 61594-046-00 Theraworx Relief for Muscle Cramps Roll-On 89 mL in 1 BOTTLE AEROSOL 89 1 61594-046-00 Theraworx Relief for Muscle Cramps Roll-On 1 in 1 CARTON AEROSOL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61594-046 THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL-ON (MAGNESIUM SULFATE, UNSPECIFIED FORM) AEROSOL [AVADIM HOLDINGS, INC.] 1 Current NDC, 2 package rows 20250101_09bd49cd-ace8-49ac-9b83-2926c0436b56.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 61594-046-00 61594004600 1 BOTTLE in 1 CARTON (61594-046-00) / 89 mL in 1 BOTTLE 1 bottle 2025-01-01 No No Current