Headache

Product NDC
43857-0488
11-digit product format
438570488
Labeler code
43857
Product ID
43857-0488_26b96831-11e6-4274-a2d2-8e3efa23e220
Type
HUMAN OTC DRUG
Nonproprietary name
Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia (Alba), Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritionals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-07-19
Substance
ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CITHARACANTHUS SPINICRUS; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; ONION; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEED
Active strength
12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 6; 12 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Headache
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA12 [hp_X]/mL
BLACK COHOSH12 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
CITHARACANTHUS SPINICRUS12 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]/mL
MELILOTUS OFFICINALIS TOP3 [hp_X]/mL
NITROGLYCERIN12 [hp_X]/mL
ONION12 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
SPIGELIA ANTHELMIA WHOLE6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWQZ3G9PF0H, K73E24S6X9, T7J046YI2B, 3Y5X6RT823, 639KR60Q1Q, HF539G9L3Q, GM6P02J2DX, G59M7S0WS3, 492225Q21H, N9288CD508, ETJ7Z6XBU4, WYT05213GE, 269XH13919

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
95250459-30e4-45c1-b08a-993044f49109Product name220250805
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
00358076-c817-430b-b924-11d717dc307cProduct name120160718
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0488-12024-10-17C16284748780-1f386c649-c572-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0488-12023-01-30C16284748780-1f386c649-c572-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0488-1Headache30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0488HEADACHE (MELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSIS) LIQUID [BIOACTIVE NUTRITIONALS, INC.]3Current NDC, Legacy NDC, 1 package rows20241019_918bc478-78a2-41e1-b123-f5350cf8f43a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0488-14385704880130 mL in 1 BOTTLE, DROPPER (43857-0488-1) 30 ml2018-07-190000-00-00NoNoCurrent