Home NDC 81825-0001 Hydrate II
Product NDC 81825-0001
11-digit product format 818250001
Labeler code 81825
Product ID 81825-0001_bcaaa148-5549-4a13-b358-47bd4354a316
Type HUMAN OTC DRUG
Nonproprietary name Berber Aqui, Beta Vulg, Boldo, Carduus Mar, Chelidonium Maj, Hordeum Vulgare, Iris Vers, Rosmarinus, Taraxacum, Avena, Eleutherococcus Senticosus, Xanthoxylum, Equisetum Hyem, Hypericum, Ulmus Fulv, Gettysburg Aqua, Glycyrrhiza, Wildbad Aqua, Carlsbad Aqua, ATP, Hydrogen, Nat Mur, Oxygen, Silicea, Wiesbaden Aqua
Dosage form LIQUID
Route ORAL
Labeler Zorex International
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-02-16
Substance ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; CHELIDONIUM MAJUS WHOLE; ELEUTHEROCOCCUS SENTICOSUS WHOLE; EQUISETUM HYEMALE WHOLE; GLYCYRRHIZA GLABRA; HORDEUM VULGARE WHOLE; HYDROGEN; HYPERICUM PERFORATUM WHOLE; IRIS VERSICOLOR ROOT; MILK THISTLE; OXYGEN; PEUMUS BOLDUS LEAF; SALVIA ROSMARINUS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; TARAXACUM OFFICINALE; ULMUS RUBRA BARK; ZANTHOXYLUM AMERICANUM BARK
Active strength 30; 8; 8; 8; 8; 8; 8; 12; 8; 34; 8; 8; 8; 30; 8; 8; 30; 30; 8; 8; 8 [hp_C]/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_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant 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 Hydrate II
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BERBERIS AQUIFOLIUM ROOT BARK 30 [hp_C]/mL BETA VULGARIS WHOLE 8 [hp_X]/mL PEUMUS BOLDUS LEAF 8 [hp_X]/mL MILK THISTLE 8 [hp_X]/mL CHELIDONIUM MAJUS WHOLE 8 [hp_X]/mL HORDEUM VULGARE WHOLE 8 [hp_X]/mL IRIS VERSICOLOR ROOT 8 [hp_X]/mL SALVIA ROSMARINUS FLOWERING TOP 12 [hp_X]/mL TARAXACUM OFFICINALE 8 [hp_X]/mL AVENA SATIVA FLOWERING TOP 34 [hp_C]/mL ELEUTHEROCOCCUS SENTICOSUS WHOLE 8 [hp_X]/mL ZANTHOXYLUM AMERICANUM BARK 8 [hp_X]/mL EQUISETUM HYEMALE WHOLE 8 [hp_X]/mL HYPERICUM PERFORATUM WHOLE 30 [hp_C]/mL ULMUS RUBRA BARK 8 [hp_X]/mL GLYCYRRHIZA GLABRA 8 [hp_X]/mL ADENOSINE TRIPHOSPHATE 30 [hp_C]/mL HYDROGEN 30 [hp_C]/mL SODIUM CHLORIDE 8 [hp_X]/mL OXYGEN 8 [hp_X]/mL SILICON DIOXIDE 8 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 21 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 81825-0001-2 Hydrate II 60 mL in 1 BOTTLE, DROPPER LIQUID 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81825-0001 HYDRATE II (BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA) LIQUID [ZOREX INTERNATIONAL] 1 Current NDC, 1 package rows 20230420_e5f53495-3b75-4d7c-89af-23058fb6fd05.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 Hydrate II BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA Zorex International e5f53495-3b75-4d7c-89af-23058fb6fd05 2018-12-21 Warnings Exact identifier ndc (product): 81825-0001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81825-0001-2 81825000102 60 mL in 1 BOTTLE, DROPPER (81825-0001-2) 60 ml 2022-02-16 No No Current