Headache

Product NDC
57520-0305
Requested package NDC
57520-0305-1
11-digit product format
575200305
Labeler code
57520
Product ID
57520-0305_f98d055a-1902-4137-ba2b-2300a0385996
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Bryonia, Gelsemium sempervirens, Glonionum, Melilotus officinalis, Natrum muriaticum, Nitricum acidum, Nux vomica, Silicea Spigelia anthelmia
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-04-12
Marketing end
2022-09-10
Substance
ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITRIC ACID; NITROGLYCERIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA; STRYCHNOS NUX-VOMICA SEED
Active strength
30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Pollen [CS], Seed Storage Proteins [CS], Vasodilation [PE]
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 packagepackage57520-030557520-0305-1DDiscontinued by firm2026-08-03

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 · 17 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0305-12022-04-04C16284748780-19d75b9d1-0cb1-f424-e053-dadaa90a57ceHeadache HP
57520-0305-12020-01-31C16284748780-19d75b9d1-0cb1-f424-e053-dadaa90a57ceHeadache HP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0HHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
MELILOTUS OFFICINALIS POLLENACTIVE INGREDIENTUVC3Z60VTXHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
NITRIC ACIDACTIVE INGREDIENT411VRN1TV4HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
SPIGELIAACTIVE INGREDIENT467D26HS0BHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0HHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
MELILOTUS OFFICINALIS POLLENACTIVE MOIETYUVC3Z60VTXHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
NITRIC ACIDACTIVE MOIETY411VRN1TV4HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
NITROGLYCERINACTIVE MOIETYG59M7S0WS3HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
SPIGELIAACTIVE MOIETY467D26HS0BHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919HEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RHEADACHE (BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONIONUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, SILICEA SPIGELIA ANTHELMIA) LIQUID [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0305-15752003050130 mL in 1 BOTTLE, DROPPER (57520-0305-1) 30 ml2010-04-122022-09-10NoNoCurrent