Quitters Relief Headache

Product NDC
54973-4005
11-digit product format
549734005
Labeler code
54973
Product ID
54973-4005_efb8c15d-1175-1db9-e053-2995a90a8fac
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS,ATROPA BELLADONNA,DELPHINIUM STAPHISAGRIA SEED,IRIS VERSICOLOR ROOT and STRYCHNOS NUX-VOMICA SEED
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-12-15
Marketing end
0000-00-00
Substance
ACONITUM NAPELLUS; ATROPA BELLADONNA; DELPHINIUM STAPHISAGRIA SEED; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED
Active strength
6 [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], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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 productproduct54973-4005DDiscontinued by firm2026-10-05
excluded packagepackage54973-400554973-4005-1DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct54973-4005DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54973-400554973-4005-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
54973-4005QUITTERS RELIEF HEADACHE (ACONITUM NAPELLUS,ATROPA BELLADONNA,DELPHINIUM STAPHISAGRIA SEED,IRIS VERSICOLOR ROOT AND STRYCHNOS NUX-VOMICA SEED) TABLET [HYLAND'S INC.]3Legacy NDC20221217_b1037662-c879-bb25-e053-2995a90af9af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4005-1549734005011 BOTTLE in 1 CARTON (54973-4005-1) > 100 TABLET in 1 BOTTLE1 bottle2020-12-150000-00-00NoNoCurrent