Decasilin

Poncirus Trifoliata Fruit, Peony Root, Platycodon Root

Chunwoo Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 72850-0005

Decasilin also known as Poncirus Trifoliata Fruit, Peony Root, Platycodon Root is a human otc drug labeled by 'Chunwoo Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Decasilin is 72850-0005. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Decasilin drug includes Ginger - 5.82 1/1001 Jujube Fruit - 17.12 1/1001 Licorice - 17.12 1/1001 Paeonia Lactiflora Root - 22.95 1/1001 Platycodon Grandiflorus Root - 17.12 1/1001 Poncirus Trifoliata Fruit - 17.12 1/1001 . The currest status of Decasilin drug is Active.

Drug Information:

Drug NDC:	72850-0005
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:	Decasilin
Also known as the trade name. It is the name of the product chosen by the labeler.
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:	Poncirus Trifoliata Fruit, Peony Root, Platycodon Root
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Chunwoo Pharmaceutical Co., Ltd.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
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:	GINGER - 5.82 1/1001 JUJUBE FRUIT - 17.12 1/1001 LICORICE - 17.12 1/1001 PAEONIA LACTIFLORA ROOT - 22.95 1/1001 PLATYCODON GRANDIFLORUS ROOT - 17.12 1/1001 PONCIRUS TRIFOLIATA FRUIT - 17.12 1/1001
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 DRUG OTHER
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:	19 Oct, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 May, 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:	Chunwoo Pharmaceutical Co., Ltd.
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:	N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0008672
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	C5529G5JPQ G55HNL2C70 61ZBX54883 3Z3866YW6P 2DF0NS0O2Z 44445L49J2
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 Plant Allergenic Extract [EPC] Non-Standardized Food 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]
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:	Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Food Additives [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:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
72850-0005-1	10 CAPSULE in 1 BLISTER PACK (72850-0005-1)	19 Oct, 2019	N/A	No
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.

Other medicines with the same generic name

Decasilin

Poncirus Trifoliata Fruit, Peony Root, Platycodon Root

Capsule
Chunwoo Pharmaceutical Co., Ltd.
NDC: 72850-0005

Purpose:

Purpose treats suppurative skin ailment with rubefaction and swell â stye â inflammation â boil â suppuration

Product Elements:

Decasilin poncirus trifoliata fruit, peony root, platycodon root poncirus trifoliata fruit poncirus trifoliata fruit paeonia lactiflora root paeonia lactiflora root ginger ginger platycodon grandiflorus root platycodon grandiflorus root jujube fruit jujube fruit licorice licorice starch, corn

Indications and Usage:

Indication & usage section take two caplets three times a day while symptoms persist.

Warnings:

Warning do not take if you have â a headache, a chill, or fever with the symptom â an abscessus frigidus(cold abscessus), or a chronic abscess. â galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption (this medicine contains lactose) ask a health professional before use it if you â have high blood pressure â have a problem with heart or kidney â have edema â are on other medication â are pregnant, breast feeding, or have chance to get pregnant â have a history of allergic reaction to medicines â are under 12 â are sensitive or have a history of allergic reaction to food yellow no. 5 (sunset yellow fcf) stop using and ask doctor â if you have following symptom â pseudoaldosteronism: reduce in urine volume, stiffness of hand, have swollen hands and feet, heavy feelings in eye lids, high blood pressure, or headache (taking licorice more than 1 g a day for long period might cause symptoms of pseudoaldosteronism Read more...

such as hypokalemia, rise in blood pressure, or low flow of sodium.) â myopathy: if feeling impuissance side effect from hypokalemia such as convulsion or numbness â skin trouble: a rash, flare, or pruritus â feeling discomfort on upper stomach â if symptoms persist after 5~6 days of using. when using this product â using for long term is not recommended, but if needed, ask a health professions. â do not exceed the recommended dosage keep out of reach of children other information â keep in dry and cool area, out of direct sunlight if possible â keep this label and enclosed materials in the box. they contain important information and putting in other container may cause misuse.

Dosage and Administration:

Uses for oral use only

Package Label Principal Display Panel:

Label

Comments/ Reviews:

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