Ludens Dual Relief

Pectin And Menthol

Prestige Brands Holdings, Inc.
Human Otc Drug
NDC 52183-227

Ludens Dual Relief also known as Pectin And Menthol is a human otc drug labeled by 'Prestige Brands Holdings, Inc.'. National Drug Code (NDC) number for Ludens Dual Relief is 52183-227. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Ludens Dual Relief drug includes Menthol - 2.5 mg/1 Pectin - 2.8 mg/1 . The currest status of Ludens Dual Relief drug is Active.

Drug Information:

Drug NDC:	52183-227
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:	Ludens Dual Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Ludens
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Dual Relief
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:	Pectin And Menthol
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Prestige Brands Holdings, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Lozenge
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:	MENTHOL - 2.5 mg/1 PECTIN - 2.8 mg/1
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:	OTC MONOGRAPH NOT FINAL
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 Jun, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Dec, 2025
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.
Application Number:	part356
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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:	Prestige Brands Holdings, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2056063 2056069
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	L7T10EIP3A 89NA02M4RX
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
52183-227-25	25 LOZENGE in 1 BAG (52183-227-25)	15 Jun, 2018	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

Ludens Dual Relief

Pectin And Menthol

Lozenge
Prestige Brands Holdings, Inc.
NDC: 52183-227

Ludens Dual Relief

Pectin And Menthol

Lozenge
Prestige Brands Holdings, Inc.
NDC: 52183-225

Purpose:

Purpose oral demulcent cough suppressant

Product Elements:

Ludens dual relief pectin and menthol pectin pectin menthol menthol corn syrup fd&c blue no. 2 fd&c red no. 40 propylene glycol sodium acetate sodium chloride soybean oil sucrose water wild cherry

Indications and Usage:

Uses temporarily relieves: minor discomfort and protection of irritated areas in sore mouth and sore throat cough associated with a cold or inhaled irritants.

Warnings:

Warnings sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. these may be serious. ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. these could be signs of a serious condition. keep out of reach of children

Dosage and Administration:

Directions adults and children 3 years of age and older : allow two drops to dissolve slowly in mouth may be repeated as needed or as directed by a doctor children under 3 years of age : ask a doctor

Stop Use:

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel ludenâs Â® cough suppressant/oral demulcent dual relief wild cherry 25 cough drops principal display panel ludenâsÂ® cough suppressant/oral demulcent dual relief wild cherry 25 cough drops

Further Questions:

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.