Home NDC 43857-0488 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
Marketing end 2026-08-31
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 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43857-0488-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43857-0488-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43857-0488-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43857-0488-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43857-0488-1 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Headache Active Ingredients# Ingredient, Strength table Ingredient Strength MELILOTUS OFFICINALIS TOP 12 [hp_X]/mL SPIGELIA ANTHELMIA WHOLE 12 [hp_X]/mL ONION 12 [hp_X]/mL ATROPA BELLADONNA 12 [hp_X]/mL BRYONIA ALBA ROOT 12 [hp_X]/mL BLACK COHOSH 12 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]/mL NITROGLYCERIN 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL SANGUINARIA CANADENSIS ROOT 12 [hp_X]/mL SILICON DIOXIDE 6 [hp_X]/mL CITHARACANTHUS SPINICRUS 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 13 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 43857-0488-1 Headache 30 mL in 1 BOTTLE, DROPPER LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43857-0488 HEADACHE (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.] 3 Current NDC, Legacy NDC, 1 package rows 20241019_918bc478-78a2-41e1-b123-f5350cf8f43a.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 MELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSIS BioActive Nutritionals, Inc. 918bc478-78a2-41e1-b123-f5350cf8f43a 2026-07-30 Warnings Exact identifier ndc (product): 43857-0488
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43857-0488-1 43857048801 30 mL in 1 BOTTLE, DROPPER (43857-0488-1) 30 ml 2018-07-19 0000-00-00 No No Current