Hydrate 2

Product NDC
43406-0592
11-digit product format
434060592
Labeler code
43406
Product ID
43406-0592_eb719df3-e5a7-4c63-8c72-54d7166b5090
Type
HUMAN OTC DRUG
Nonproprietary name
BerberisAquifolium,BetaVulgaris,Boldo,ChelidoniumMajus,HordeumVulgare,IrisVersicolor,RosmarinusOfficinalis,CarduusMarianus,TaraxacumOfficinale,AvenaSativa,EleutherococcusSenticosus,XanthoxylumFraxineum,EquisetumHyemale,HypericumPerforatum,UlmusFulva,GettysburgAqua,GlycyrrhizaGlabra,WildbadAqua,CarlsbadAqua,ATP,Hydrogen,NatrumMuriaticum,Oxygen,Silicea,WiesbadenAqua
Dosage form
LIQUID
Route
ORAL
Labeler
Natural Creations, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-11-23
Substance
ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS; CHELIDONIUM MAJUS; ELEUTHEROCOCCUS SENTICOSUS WHOLE; EQUISETUM HYEMALE; GLYCYRRHIZA GLABRA; HORDEUM VULGARE WHOLE; HYDROGEN; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; MILK THISTLE; OXYGEN; PEUMUS BOLDUS LEAF; ROSMARINUS OFFICINALIS 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; 30; 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 2
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 VULGARIS8 [hp_X]/mL
CHELIDONIUM MAJUS8 [hp_X]/mL
ELEUTHEROCOCCUS SENTICOSUS WHOLE8 [hp_X]/mL
EQUISETUM HYEMALE8 [hp_X]/mL
GLYCYRRHIZA GLABRA12 [hp_X]/mL
HORDEUM VULGARE WHOLE8 [hp_X]/mL
HYDROGEN30 [hp_C]/mL
HYPERICUM PERFORATUM8 [hp_X]/mL
IRIS VERSICOLOR ROOT8 [hp_X]/mL
MILK THISTLE8 [hp_X]/mL
OXYGEN30 [hp_C]/mL
PEUMUS BOLDUS LEAF8 [hp_X]/mL
ROSMARINUS OFFICINALIS 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
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0592-22021-11-12C16284748780-1ba0f9c33-3234-a910-e053-dadaa90a0b85HYDRATE 2
43406-0592-22021-01-29C16284748780-1ba0f9c33-3234-a910-e053-dadaa90a0b85HYDRATE 2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0592-2Hydrate 260 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0592HYDRATE 2 (BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA) LIQUID [NATURAL CREATIONS, INC]2Current NDC, Legacy NDC, 1 package rows20211113_52cb98dc-6858-42bf-9c54-d20fb607dfbb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43406-0592-24340605920260 mL in 1 BOTTLE, DROPPER (43406-0592-2) 60 ml2015-11-230000-00-00NoNoCurrent