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
IngredientStrength
ADENOSINE TRIPHOSPHATE30 [hp_C]/mL
AVENA SATIVA FLOWERING TOP8 [hp_X]/mL
BERBERIS AQUIFOLIUM ROOT BARK8 [hp_X]/mL
BETA VULGARIS WHOLE8 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE8 [hp_X]/mL
ELEUTHEROCOCCUS SENTICOSUS WHOLE8 [hp_X]/mL
EQUISETUM HYEMALE WHOLE8 [hp_X]/mL
GLYCYRRHIZA GLABRA12 [hp_X]/mL
HORDEUM VULGARE WHOLE8 [hp_X]/mL
HYDROGEN34 [hp_C]/mL
HYPERICUM PERFORATUM WHOLE8 [hp_X]/mL
IRIS VERSICOLOR ROOT8 [hp_X]/mL
MILK THISTLE8 [hp_X]/mL
OXYGEN30 [hp_C]/mL
PEUMUS BOLDUS LEAF8 [hp_X]/mL
SALVIA ROSMARINUS FLOWERING TOP8 [hp_X]/mL
SILICON DIOXIDE30 [hp_C]/mL
SODIUM CHLORIDE30 [hp_C]/mL
TARAXACUM OFFICINALE8 [hp_X]/mL
ULMUS RUBRA BARK8 [hp_X]/mL
ZANTHOXYLUM AMERICANUM BARK8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8L70Q75FXE, MA9CQJ3F7F, VZJ9F3C3SB, 4G174V5051, 7E889U5RNN, ZX5Z2LW23O, 59677RXH25, 2788Z9758H, 8JBE478M5Q, 7YNJ3PO35Z, XK4IUX8MNB, X43D4L3DQC, U946SH95EE, S88TT14065, Q4EWM09M3O, 8JM482TI79, ETJ7Z6XBU4, 451W47IQ8X, 39981FM375, 91QY4PXU8Q

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81825-0001-2Hydrate II60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81825-0001HYDRATE 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]1Current NDC, 1 package rows20230420_e5f53495-3b75-4d7c-89af-23058fb6fd05.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81825-0001-28182500010260 mL in 1 BOTTLE, DROPPER (81825-0001-2) 60 ml2022-02-16NoNoHistorical