Migraide

Product NDC
53499-2391
Requested package NDC
53499-2391-1
11-digit product format
534992391
Labeler code
53499
Product ID
53499-2391_7b67343b-d693-4cbd-964e-4d673a401a3e
Type
HUMAN OTC DRUG
Nonproprietary name
CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-07-02
Marketing end
2025-12-31
Substance
CYCLAMEN PURPURASCENS TUBER; BLACK COHOSH; IRIS VERSICOLOR WHOLE; GELSEMIUM SEMPERVIRENS WHOLE; SANGUINARIA CANADENSIS ROOT
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53499-239153499-2391-1DDiscontinued by firm2026-10-16

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
53499-2391MIGRAIDE (CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT) TABLET [SCHWABE NORTH AMERICA, INC.]6Legacy NDC20211111_d93e48c9-94d6-4d60-8245-cd1ee9f54816.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-2391-1534992391014 BLISTER PACK in 1 BOX (53499-2391-1) > 10 TABLET in 1 BLISTER PACK4 blister pack2015-07-022025-12-31NoNoCurrent