Home NDC 81825-0003 E.N.V.
Product NDC 81825-0003
11-digit product format 818250003
Labeler code 81825
Product ID 81825-0003_70783c3e-4437-477e-8a45-0345fbcf573a
Type HUMAN OTC DRUG
Nonproprietary name Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb
Dosage form LIQUID
Route ORAL
Labeler Zorex International
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2021-12-08
Substance ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT
Active strength 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage 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 E.N.V.
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPA BELLADONNA 30 [hp_C]/mL BERBERIS VULGARIS ROOT BARK 30 [hp_C]/mL MILK THISTLE 30 [hp_C]/mL CHELIDONIUM MAJUS WHOLE 30 [hp_C]/mL CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/mL DIOSCOREA VILLOSA TUBER 30 [hp_C]/mL GOLDENSEAL 30 [hp_C]/mL LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL SODIUM SULFATE 30 [hp_C]/mL STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL PHOSPHORUS 30 [hp_C]/mL PULSATILLA VULGARIS WHOLE 30 [hp_C]/mL VERATRUM ALBUM ROOT 30 [hp_C]/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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81825-0003-1 E.N.V. 30 mL in 1 BOTTLE, DROPPER LIQUID 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81825-0003 E.N.V. (BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALB) LIQUID [ZOREX INTERNATIONAL] 1 Current NDC, 1 package rows 20230422_838498ba-cab9-4e1b-a567-e7f1862b7fbb.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 E.N.V. BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALB Zorex International 838498ba-cab9-4e1b-a567-e7f1862b7fbb 2018-12-21 Warnings Exact identifier ndc (product): 81825-0003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81825-0003-1 81825000301 30 mL in 1 BOTTLE, DROPPER (81825-0003-1) 30 ml 2021-12-08 No No Current