Migraine Relief

Product NDC
54973-4030
11-digit product format
549734030
Labeler code
54973
Product ID
54973-4030_efb7ae5d-9017-5a5c-e053-2a95a90a36a1
Type
HUMAN OTC DRUG
Nonproprietary name
Gelsemium Sempervirens Root, Strychnos Nux-Vomica Seed, Iris Versicolor Root, Sanguinaria Canadensis Root, Atropa Belladonna and Nitroglycerin
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; NITROGLYCERIN; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED
Active strength
6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54973-4030DDiscontinued by firm2026-10-12
excluded packagepackage54973-403054973-4030-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4030MIGRAINE RELIEF (GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, ATROPA BELLADONNA AND NITROGLYCERIN) TABLET [HYLAND'S INC]4Legacy NDC20250321_a4fc6445-40c0-73ef-e053-2995a90ae6a4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4030-1549734030011 BOTTLE in 1 CARTON (54973-4030-1) > 100 TABLET in 1 BOTTLE1 bottle2020-03-300000-00-00NoNoCurrent