Home NDC 43857-0507-1 Headache Tonic
Product NDC 43857-0507
Requested package NDC 43857-0507-1
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
Additional Listing Data#
Finished product Yes
Brand name base Headache Tonic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MILK THISTLE 12 [hp_X]/mL TANACETUM PARTHENIUM WHOLE 12 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM 12 [hp_X]/mL ACONITUM NAPELLUS WHOLE 6 [hp_X]/mL ATROPA BELLADONNA 12 [hp_X]/mL BRYONIA ALBA ROOT 12 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT 1 [hp_X]/mL NITROGLYCERIN 12 [hp_X]/mL MELILOTUS OFFICINALIS TOP 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL SEPIA OFFICINALIS JUICE 12 [hp_X]/mL SPIGELIA ANTHELMIA WHOLE 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 12 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43857-0507-1 Headache Tonic 60 mL in 1 BOTTLE, DROPPER LIQUID 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0507 HEADACHE 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.] 4 Current NDC, Legacy NDC, 1 package rows 20241019_a6526cc4-028b-45df-ac1f-c3cec7556e93.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Headache Tonic CARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIA BioActive Nutritional, Inc. a6526cc4-028b-45df-ac1f-c3cec7556e93 2024-10-17 Warnings Exact identifier ndc (package): 43857-0507-1 ndc (product): 43857-0507 ndc11 (package): 43857050701
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43857-0507-1 43857050701 60 mL in 1 BOTTLE, DROPPER (43857-0507-1) 60 ml 2019-04-30 No No Current