Home NDC 54973-4011 Backache Relief
Product NDC 54973-4011
11-digit product format 549734011
Labeler code 54973
Product ID 54973-4011_fb5962be-5af1-206f-e053-6294a90aa8b0
Type HUMAN OTC DRUG
Nonproprietary name Aconitum Napellus, Bryonia Alba Root, Magnesium Phosphate, Dibasic Trihydrate, Bellis Perennis, Toxicodendron Pubescens Leaf and Arnica Montana
Dosage form TABLET
Route ORAL
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2020-03-30
Substance ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF
Active strength 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
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 Backache Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARNICA MONTANA 6 [hp_X]/1 BELLIS PERENNIS 6 [hp_X]/1 ACONITUM NAPELLUS 6 [hp_X]/1 BRYONIA ALBA ROOT 6 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/1 TOXICODENDRON PUBESCENS LEAF 6 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 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 54973-4011-1 Backache Relief 1 in 1 CARTON TABLET 1 4 54973-4011-1 Backache Relief 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-4011 BACKACHE RELIEF (ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANA) TABLET [HYLAND'S INC.] 4 Current NDC, Legacy NDC, 2 package rows 20230511_a51452b3-0aba-6928-e053-2995a90a1619.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 Backache Relief ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANA Hyland's Inc. a51452b3-0aba-6928-e053-2995a90a1619 2023-05-10 Warnings Exact identifier ndc (product): 54973-4011
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-4011-1 54973401101 1 BOTTLE in 1 CARTON (54973-4011-1) / 100 TABLET in 1 BOTTLE 1 bottle 2020-03-30 0000-00-00 No No Current