Home NDC 61594-011 PHUEL
Product NDC 61594-011
11-digit product format 615940011
Labeler code 61594
Product ID 61594-011_fa232638-86cb-780a-e053-6394a90a30a2
Type HUMAN OTC DRUG
Nonproprietary name MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form SPRAY
Route TOPICAL
Labeler AVADIM HOLDINGS, INC.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-11-07
Substance MAGNESIUM SULFATE HEPTAHYDRATE
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 PHUEL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MAGNESIUM SULFATE HEPTAHYDRATE 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 SK47B8698T 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 61594-011-07 PHUEL 210 mL in 1 BOTTLE, PLASTIC SPRAY 210 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61594-011 PHUEL (MAGNESIUM SULFATE HEPTAHYDRATE) SPRAY [AVADIM HOLDINGS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20230426_f5c012a3-52ad-40fe-aa02-e26efc23c81f.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PHUEL MAGNESIUM SULFATE HEPTAHYDRATE AVADIM HOLDINGS, INC. f5c012a3-52ad-40fe-aa02-e26efc23c81f 2023-04-25 Warnings Exact identifier ndc (product): 61594-011
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61594-011-07 61594001107 210 mL in 1 BOTTLE, PLASTIC (61594-011-07) 210 ml 2018-11-07 0000-00-00 No No Current