NDC 0363-1096 Walgreens Throat Relief Pops - Clean Label

Pectin

NDC Product Code 0363-1096

NDC Code: 0363-1096

Proprietary Name: Walgreens Throat Relief Pops - Clean Label 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: Pectin 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.

NDC Code Structure

  • 0363 - Walgreen
    • 0363-1096 - Walgreens Throat Relief Pops - Clean Label

NDC 0363-1096-15

Package Description: 15 LOZENGE in 1 BAG

NDC Product Information

Walgreens Throat Relief Pops - Clean Label with NDC 0363-1096 is a a human over the counter drug product labeled by Walgreen. The generic name of Walgreens Throat Relief Pops - Clean Label is pectin. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Walgreen

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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.

Walgreens Throat Relief Pops - Clean Label 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.

  • PECTIN 12 mg/1

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.

  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

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

Labeler Name: Walgreen
Labeler Code: 0363
FDA Application Number: part356 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-09-2019 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.

Walgreens Throat Relief Pops - Clean Label 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

Otc - Active Ingredient

Active ingredient (in each pop)Pectin 12 mg

Otc - Purpose

PurposeOral demulcent

Indications & Usage

UsesFor temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

WarningsSore throat warning: if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These symptoms may be serious.

Otc - Stop Use

  • Stop use and ask doctor ifirritation, pain or redness persists or worsenssore mouth does not improve in 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directionsadults and children 3 years and over - allow 1 pop to dissolve slowly in mouth. May be repeated as necessary or as directed by a doctor.children under 3 years - ask a doctor

Other Safety Information

  • Other information15 calories per lollipopNot a candyDo not use if bag is torn or open

Inactive Ingredient

Inactive ingredients: Citric acid, corn starch, natural flavors, Organic Liquid Raw Cane Sugar, Organic Rice Syrup, sodium citrate, soybean oil and water.

Otc - Questions

Questions? Or to report an adverse event call
1-800-245-2898. Monday - Friday, 9AM to 4PM EST

* Please review the disclaimer below.

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