headache

Generic: melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia (alba), cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis

Labeler: bioactive nutritionals, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name headache
Generic Name melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia (alba), cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis
Labeler bioactive nutritionals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

atropa belladonna 12 [hp_X]/mL, black cohosh 12 [hp_X]/mL, bryonia alba root 12 [hp_X]/mL, citharacanthus spinicrus 12 [hp_X]/mL, gelsemium sempervirens root 12 [hp_X]/mL, magnesium phosphate, dibasic trihydrate 12 [hp_X]/mL, melilotus officinalis top 3 [hp_X]/mL, nitroglycerin 12 [hp_X]/mL, onion 12 [hp_X]/mL, sanguinaria canadensis root 12 [hp_X]/mL, silicon dioxide 12 [hp_X]/mL, spigelia anthelmia whole 6 [hp_X]/mL, strychnos nux-vomica seed 12 [hp_X]/mL

Manufacturer
BioActive Nutritionals, Inc.

Identifiers & Regulatory

Product NDC 43857-0488
Product ID 43857-0488_26b96831-11e6-4274-a2d2-8e3efa23e220
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2018-07-19

Pharmacologic Class

Established (EPC)
nitrate vasodilator [epc] non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
nitrates [cs] allergens [cs] dietary proteins [cs] vegetable proteins [cs] plant proteins [cs] seed storage proteins [cs]
Physiologic Effect
vasodilation [pe] increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 438570488
Hyphenated Format 43857-0488

Supplemental Identifiers

UNII
WQZ3G9PF0H K73E24S6X9 T7J046YI2B 3Y5X6RT823 639KR60Q1Q HF539G9L3Q GM6P02J2DX G59M7S0WS3 492225Q21H N9288CD508 ETJ7Z6XBU4 WYT05213GE 269XH13919
NUI
N0000175415 M0014874 N0000009909 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 N0000185375 N0000185001 M0016962 M0516536

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name headache (source: ndc)
Generic Name melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia (alba), cimicifuga racemosa, gelsemium sempervirens, glonoinum, magnesia phosphorica, nux vomica, sanguinaria canadensis, silicea, tarentula cubensis (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 [hp_X]/mL
  • 3 [hp_X]/mL
  • 6 [hp_X]/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (43857-0488-1)
source: ndc

Packages (1)

Ingredients (13)

atropa belladonna (12 [hp_X]/mL) black cohosh (12 [hp_X]/mL) bryonia alba root (12 [hp_X]/mL) citharacanthus spinicrus (12 [hp_X]/mL) gelsemium sempervirens root (12 [hp_X]/mL) magnesium phosphate, dibasic trihydrate (12 [hp_X]/mL) melilotus officinalis top (3 [hp_X]/mL) nitroglycerin (12 [hp_X]/mL) onion (12 [hp_X]/mL) sanguinaria canadensis root (12 [hp_X]/mL) silicon dioxide (12 [hp_X]/mL) spigelia anthelmia whole (6 [hp_X]/mL) strychnos nux-vomica seed (12 [hp_X]/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "26b96831-11e6-4274-a2d2-8e3efa23e220", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909", "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0022575", "N0000185375", "N0000185001", "M0016962", "M0516536"], "unii": ["WQZ3G9PF0H", "K73E24S6X9", "T7J046YI2B", "3Y5X6RT823", "639KR60Q1Q", "HF539G9L3Q", "GM6P02J2DX", "G59M7S0WS3", "492225Q21H", "N9288CD508", "ETJ7Z6XBU4", "WYT05213GE", "269XH13919"], "spl_set_id": ["918bc478-78a2-41e1-b123-f5350cf8f43a"], "pharm_class_cs": ["Nitrates [CS]", "Allergens [CS]", "Dietary Proteins [CS]", "Vegetable Proteins [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]"], "pharm_class_pe": ["Vasodilation [PE]", "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["BioActive Nutritionals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (43857-0488-1)", "package_ndc": "43857-0488-1", "marketing_start_date": "20180719"}], "brand_name": "Headache", "product_id": "43857-0488_26b96831-11e6-4274-a2d2-8e3efa23e220", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Allergens [CS]", "Calculi Dissolution Agent [EPC]", "Cell-mediated Immunity [PE]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Increased Histamine Release [PE]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]", "Vasodilation [PE]", "Vegetable Proteins [CS]"], "product_ndc": "43857-0488", "generic_name": "Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis", "labeler_name": "BioActive Nutritionals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Headache", "active_ingredients": [{"name": "ATROPA BELLADONNA", "strength": "12 [hp_X]/mL"}, {"name": "BLACK COHOSH", "strength": "12 [hp_X]/mL"}, {"name": "BRYONIA ALBA ROOT", "strength": "12 [hp_X]/mL"}, {"name": "CITHARACANTHUS SPINICRUS", "strength": "12 [hp_X]/mL"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "strength": "12 [hp_X]/mL"}, {"name": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE", "strength": "12 [hp_X]/mL"}, {"name": "MELILOTUS OFFICINALIS TOP", "strength": "3 [hp_X]/mL"}, {"name": "NITROGLYCERIN", "strength": "12 [hp_X]/mL"}, {"name": "ONION", "strength": "12 [hp_X]/mL"}, {"name": "SANGUINARIA CANADENSIS ROOT", "strength": "12 [hp_X]/mL"}, {"name": "SILICON DIOXIDE", "strength": "12 [hp_X]/mL"}, {"name": "SPIGELIA ANTHELMIA WHOLE", "strength": "6 [hp_X]/mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "strength": "12 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20180719", "listing_expiration_date": "20261231"}