FDA.reportPublic FDA data

Headache Tonic

Product NDC
43857-0507
11-digit product format
438570507
Labeler code
43857
Product ID
43857-0507_f4d7a7e3-3951-444e-a65e-78aebe52c7c9
Type
HUMAN OTC DRUG
Nonproprietary name
Carduus Marianus, Pyrethrum Parthenium, Secale Cornutum, Aconitum Napellus, Belladonna, Bryonia (Alba), Gelsemium Sempervirens, Glonoinum, Melilotus Officinalis, Nux Vomica, Sepia, Spigelia Anthelmia
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-04-30
Substance
ACONITUM NAPELLUS WHOLE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS TOP; MILK THISTLE; NITROGLYCERIN; SEPIA OFFICINALIS JUICE; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEED; TANACETUM PARTHENIUM WHOLE
Active strength
12; 12; 12; 6; 12; 12; 1; 12; 12; 12; 12; 6 [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], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE12 [hp_X]/mL
ATROPA BELLADONNA12 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/mL
MELILOTUS OFFICINALIS TOP12 [hp_X]/mL
MILK THISTLE1 [hp_X]/mL
NITROGLYCERIN12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SPIGELIA ANTHELMIA WHOLE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TANACETUM PARTHENIUM WHOLE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, WQZ3G9PF0H, T7J046YI2B, 01G9XEA93N, 639KR60Q1Q, GM6P02J2DX, U946SH95EE, G59M7S0WS3, QDL83WN8C2, WYT05213GE, 269XH13919, 6GE7Z0761K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0507-12024-10-17C16284748780-1ba0f9c33-1cf1-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0507-12021-01-29C16284748780-1ba0f9c33-1cf1-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0507-1Headache Tonic60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0507HEADACHE TONIC (CARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20241019_a6526cc4-028b-45df-ac1f-c3cec7556e93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0507-14385705070160 mL in 1 BOTTLE, DROPPER (43857-0507-1) 60 ml2019-04-30NoNoCurrent