Hydrate
DRUG FACTS:
Approved
Approval ID
320c9fb7-9c3f-44a5-8c34-13266b036cca
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Maplewood Company
DUNS: 022963389
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51987-0002
Product Classification
G
Generic Name
Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (15)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
COFFEA ARABICA SEED, ROASTEDActive
Quantity: 2 [hp_X] in 1 mL
Code: 9H58JRT35E
Classification: ACTIM
AVENA SATIVA FLOWERING TOPActive
Quantity: 3 [hp_X] in 1 mL
Code: MA9CQJ3F7F
Classification: ACTIB
EQUISETUM HYEMALEActive
Quantity: 3 [hp_X] in 1 mL
Code: 59677RXH25
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: ETJ7Z6XBU4
Classification: ACTIB
CHELIDONIUM MAJUSInactive
Code: 7E889U5RNN
Classification: IACT
GINKGOActive
Quantity: 6 [hp_X] in 1 mL
Code: 19FUJ2C58T
Classification: ACTIB
BEETInactive
Code: N487KM8COK
Classification: IACT
CENTAUREA BENEDICTA FLOWERING TOPInactive
Code: NJN80GZ34N
Classification: IACT
PEUMUS BOLDUS LEAFInactive
Code: Q4EWM09M3O
Classification: IACT
TARAXACUM OFFICINALEInactive
Code: 39981FM375
Classification: IACT
PETROSELINUM CRISPUMInactive
Code: 1WZA4Y92EX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPERICUM PERFORATUMActive
Quantity: 3 [hp_X] in 1 mL
Code: XK4IUX8MNB
Classification: ACTIB
GERMANIUM SESQUIOXIDEActive
Quantity: 8 [hp_X] in 1 mL
Code: 96WE91N25T
Classification: ACTIB