NDC 72559-007 Curist Allergy Relief

Levocetirizine Dihydrochloride

NDC Product Code 72559-007

NDC CODE: 72559-007

Proprietary Name: Curist Allergy Relief What is the Proprietary Name?
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: Levocetirizine Dihydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Levocetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). If your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine.

Product Characteristics

WHITE (C48325)
Shape: OVAL (C48345)
8 MM
Score: 2

NDC Code Structure

  • 72559 - Little Pharma, Inc.

NDC 72559-007-05

Package Description: 1 BOTTLE in 1 CARTON > 90 TABLET in 1 BOTTLE

NDC Product Information

Curist Allergy Relief with NDC 72559-007 is a a human over the counter drug product labeled by Little Pharma, Inc.. The generic name of Curist Allergy Relief is levocetirizine dihydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Little Pharma, Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
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.

Curist Allergy Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Little Pharma, Inc.
Labeler Code: 72559
FDA Application Number: ANDA211551 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
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.

Start Marketing Date: 10-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients


Levocetirizine is pronounced as (lee'' voe se tir' i zeen)

Why is levocetirizine medication prescribed?
Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other subs...
[Read More]

* Please review the disclaimer below.

Curist Allergy Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Read directions and warnings before use. Keep carton as it contains important information.Drug Facts

Distributed by:Little Pharma, Inc. New York, NY 10023Made in India

Otc - Active Ingredient

Active ingredient (in each tablet)Levocetirizine dihydrochloride USP 5 mg

Otc - Purpose


Indications & Usage

  • Usestemporarily relieves these symptoms due to hay fever or other respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat



Otc - Do Not Use

  • Do not useif you have
  • Kidney diseaseif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Otc - Ask Doctor

Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.

Otc - When Using

  • When using this productdrowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Otc - Stop Use

  • Stop use and ask a doctor ifyou have trouble urinating or emptying your bladderan allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast-feeding,if breast-feeding: not recommendedif pregnant: ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

  • Directionsadults 65 years and olderask a doctoradults and children 12-64 yearstake 1 tablet (5 mg) once daily in the eveningdo not take more than 1 tablet (5 mg) in 24 hours½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomschildren 6-11 yearstake ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hourschildren under 6 yearsdo not useconsumers with kidney diseasedo not use

Storage And Handling

  • Other information​store between 20° and 25°C (68° and 77°F)safety sealed: do not use if carton was opened or torn

Inactive Ingredient

Inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, titanium dioxide

Otc - Questions

Questions? call

* Please review the disclaimer below.