Southwest Regional 1020

Southwest Regional


Professional Complementary Health Formulas
Human Otc Drug
NDC 63083-1020
Southwest Regional 1020 also known as Southwest Regional is a human otc drug labeled by 'Professional Complementary Health Formulas'. National Drug Code (NDC) number for Southwest Regional 1020 is 63083-1020. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Southwest Regional 1020 drug includes Acer Negundo Root Bark - 6 [hp_X]/59mL Amaranthus Hybridus Leaf - 6 [hp_X]/59mL Amaranthus Tuberculatus Pollen - 6 [hp_X]/59mL Ambrosia Artemisiifolia Whole - 6 [hp_X]/59mL Baccharis Pilularis Whole - 6 [hp_X]/59mL Bassia Scoparia Fruit - 6 [hp_X]/59mL Beef Liver - 6 [hp_X]/59mL Betula Occidentalis Pollen - 6 [hp_X]/59mL Carya Laciniosa Bark - 6 [hp_X]/59mL Chenopodium Album Pollen - 6 [hp_X]/59mL and more. The currest status of Southwest Regional 1020 drug is Active.

Drug Information:

Drug NDC: 63083-1020
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.
Proprietary Name: Southwest Regional 1020
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Southwest Regional
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: 1020
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Southwest Regional
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Professional Complementary Health Formulas
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ACER NEGUNDO ROOT BARK - 6 [hp_X]/59mL
AMARANTHUS HYBRIDUS LEAF - 6 [hp_X]/59mL
AMARANTHUS TUBERCULATUS POLLEN - 6 [hp_X]/59mL
AMBROSIA ARTEMISIIFOLIA WHOLE - 6 [hp_X]/59mL
BACCHARIS PILULARIS WHOLE - 6 [hp_X]/59mL
BASSIA SCOPARIA FRUIT - 6 [hp_X]/59mL
BEEF LIVER - 6 [hp_X]/59mL
BETULA OCCIDENTALIS POLLEN - 6 [hp_X]/59mL
CARYA LACINIOSA BARK - 6 [hp_X]/59mL
CHENOPODIUM ALBUM POLLEN - 6 [hp_X]/59mL
CITRUS SINENSIS POLLEN - 6 [hp_X]/59mL
CORTICOTROPIN - 6 [hp_X]/59mL
CYNODON DACTYLON WHOLE - 6 [hp_X]/59mL
ELM - 6 [hp_X]/59mL
ENGLISH WALNUT - 6 [hp_X]/59mL
EPHEDRA NEVADENSIS WHOLE - 6 [hp_X]/59mL
FRAXINUS LATIFOLIA WHOLE - 6 [hp_X]/59mL
HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59mL
IVA ANGUSTIFOLIA WHOLE - 6 [hp_X]/59mL
JUNIPERUS SCOPULORUM POLLEN - 6 [hp_X]/59mL
LIGUSTRUM LUCIDUM SEED - 6 [hp_X]/59mL
MEDICAGO SATIVA WHOLE - 6 [hp_X]/59mL
OLEA EUROPAEA FLOWER - 6 [hp_X]/59mL
PECAN - 6 [hp_X]/59mL
PINUS CEMBROIDES POLLEN - 6 [hp_X]/59mL
PINUS PONDEROSA POLLEN - 6 [hp_X]/59mL
PLANTAGO AUSTRALIS WHOLE - 6 [hp_X]/59mL
POPULUS FREMONTII POLLEN - 6 [hp_X]/59mL
POPULUS TREMULOIDES POLLEN - 6 [hp_X]/59mL
PROSOPIS CINERARIA WOOD - 6 [hp_X]/59mL
QUERCUS KELLOGGII POLLEN - 6 [hp_X]/59mL
RUMEX CRISPUS ROOT - 6 [hp_X]/59mL
SAGE - 6 [hp_X]/59mL
SALIX LUTEA POLLEN - 6 [hp_X]/59mL
SALSOLA KALI WHOLE - 6 [hp_X]/59mL
SUAEDA MARITIMA FLOWERING TOP - 6 [hp_X]/59mL
SUS SCROFA ADRENAL GLAND - 6 [hp_X]/59mL
SYMPHORICARPOS ALBUS FRUIT - 6 [hp_X]/59mL
TAMARIX GALLICA POLLEN - 6 [hp_X]/59mL
WHITE MULBERRY - 6 [hp_X]/59mL
XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - 6 [hp_X]/59mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 15 Aug, 1984
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 18 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Professional Complementary Health Formulas
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000185367
N0000175629
N0000184306
M0017130
M0000728
N0000185001
N0000185371
M0006342
N0000185017
M0000499
N0000175941
N0000185019
N0000185375
M0016962
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:56W138ID6K
07L86FJ69J
92N6W6KO2G
9W34L2CQ9A
U8I5N8Q01B
04W97Z676Y
W8N8R55022
R889N2L976
98Q86P6WFR
098LKX5NCN
0U790UB32K
K0U68Q2TXA
2Q8MR21NHK
63POE2M46Y
1V3SHR7QB7
046PB542M7
024W88F557
3POA0Q644U
1BTG48T6EA
0G82TT8ZFY
1A3CS89UKD
DJO934BRBD
498M34P1VZ
F14P91GB5F
956F61CB2V
042SUA2DS9
0008D0X3XI
426RHB4302
928OC2TJDA
06ZPE0373L
02RVY6X9EC
9N1RM2S62C
065C5D077J
012RCE5TWE
0BKP293XE9
0K803ZTV5N
398IYQ16YV
873JZU3ASZ
43IR7KR479
MN25R0HH5A
0ZK6G3W3BI
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Non-Standardized Pollen Allergenic Extract [EPC]
Non-Standardized Food Allergenic Extract [EPC]
Adrenocorticotropic Hormone [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Pollen [CS]
Allergens [CS]
Dietary Proteins [CS]
Adrenocorticotropic Hormone [CS]
Plant Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Adrenocorticotropic Hormone [CS]
Adrenocorticotropic Hormone [EPC]
Allergens [CS]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Meat Proteins [EXT]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Non-Standardized Pollen Allergenic Extract [EPC]
Nut Proteins [EXT]
Plant Proteins [CS]
Pollen [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63083-1020-259 mL in 1 BOTTLE, DROPPER (63083-1020-2)15 Aug, 1985N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

*claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Southwest regional 1020 southwest regional sus scrofa adrenal gland sus scrofa adrenal gland corticotropin corticotropin histamine dihydrochloride histamine beef liver beef liver populus fremontii pollen populus fremontii pollen fraxinus latifolia whole fraxinus latifolia whole populus tremuloides pollen populus tremuloides pollen suaeda maritima flowering top suaeda maritima flowering top cynodon dactylon whole cynodon dactylon whole betula occidentalis pollen betula occidentalis pollen acer negundo root bark acer negundo root bark bassia scoparia fruit bassia scoparia fruit xanthium strumarium var. canadense pollen xanthium strumarium var. canadense pollen baccharis pilularis whole baccharis pilularis whole elm elm medicago sativa whole medicago sativa whole carya laciniosa bark carya laciniosa bark juniperus scopulorum pollen juniperus scopulorum pollen chenopodium album pollen chenopodium album pollen iva angustifolia whole iva angustifolia whole prosopis cineraria wood prosopis cineraria wood ephedra nevadensis whole ephedra nevadensis whole white mulberry white mulberry quercus kelloggii pollen quercus kelloggii pollen olea europaea flower olea europaea flower citrus sinensis pollen citrus sinensis pollen pecan pecan amaranthus hybridus leaf amaranthus hybridus leaf pinus ponderosa pollen pinus ponderosa pollen pinus cembroides pollen pinus cembroides pollen plantago australis whole plantago australis whole ligustrum lucidum seed ligustrum lucidum seed ambrosia artemisiifolia whole ambrosia artemisiifolia whole rumex crispus root rumex crispus root salsola kali whole salsola kali whole sage sage tamarix gallica pollen tamarix gallica pollen symphoricarpos albus fruit symphoricarpos albus fruit english walnut english walnut amaranthus tuberculatus pollen amaranthus tuberculatus pollen salix lutea pollen salix lutea pollen alcohol water

Indications and Usage:

Indications for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to sensitivity to common allergens of the southwestern united states.*

Warnings:

Warnings in case of overdose, get medical help or contact a poison control center right away. keep out of the reach of children. if pregnant or breastfeeding, ask a healthcare professional before use.

Dosage and Administration:

Directions place drops under tongue 30 minutes before/after meals. adults and children 12 years and over: take 10 to 15 drops up to 3 times per day. for desensitization, begin with 1 to 5 drops daily, increasing to the standard dose gradually to avoid symptom expression; after 1 to 3 months at the standard dose, decrease gradually to a maintenance dose of 10 to 15 drops weekly. consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

Label est 1985 professional formulas complementary health southwest regional homeopathic remedy 2 fl. oz. (59 ml) label image

Further Questions:

Questions professional formulas po box 2034 lake oswego, or 97035


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.