54638-0004 NDC - REHYDRATE JR. (AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, GLYCYRRHIZA GLABRA, PUERARIA LOBATA, AQUA SULIS, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGENIUM, WIESBADEN)

Drug Information

Product NDC: 54638-0004
Proprietary Name: Rehydrate Jr.
Non Proprietary Name: Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Glycyrrhiza Glabra, Pueraria Lobata, Aqua Sulis, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygenium, Wiesbaden
Active Ingredient(s): 30 [hp_C]/mL ADENOSINE TRIPHOSPHATE DISODIUM; 3 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 4 [hp_X]/mL EQUISETUM HYEMALE; 30 [hp_C]/mL GERMANIUM SESQUIOXIDE; 12 [hp_X]/mL GLYCYRRHIZA GLABRA; 30 [hp_C]/mL HYDROGEN; 6 [hp_X]/mL HYPERICUM PERFORATUM; 30 [hp_C]/mL OXYGEN; 12 [hp_X]/mL PUERARIA MONTANA VAR. LOBATA ROOT; 6 [hp_X]/mL ULMUS RUBRA BARK; 12 [hp_C]/mL WATER
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): 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]

Labeler Information

Field Name	Field Value
Labeler Name:	ParaDocs All Natural, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	3/11/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	54638-0004-1	60 mL in 1 BOTTLE, DROPPER (54638-0004-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	54638-0004	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Rehydrate Jr.	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Glycyrrhiza Glabra, Pueraria Lobata, Aqua Sulis, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygenium, Wiesbaden	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/11/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	ParaDocs All Natural, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ADENOSINE TRIPHOSPHATE DISODIUM; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; HYDROGEN; HYPERICUM PERFORATUM; OXYGEN; PUERARIA MONTANA VAR. LOBATA ROOT; ULMUS RUBRA BARK; WATER	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 12
ACTIVE INGRED UNIT	[hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
PHARM 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]

54638-0004 NDC - REHYDRATE JR. (AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, GLYCYRRHIZA GLABRA, PUERARIA LOBATA, AQUA SULIS, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGENIUM, WIESBADEN)

Drug Information

Labeler Information

Package Information

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