NDC 73328-001 Wellements Throat Pops


NDC Product Code 73328-001

NDC 73328-001-10

Package Description: 10 LOZENGE in 1 BOX

NDC Product Information

Wellements Throat Pops with NDC 73328-001 is a a human over the counter drug product labeled by Wellements Llc. The generic name of Wellements Throat Pops is pectin. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Wellements Llc

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.

Wellements Throat Pops 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 11.5 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.

  • SUCROSE (UNII: C151H8M554)

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: Wellements Llc
Labeler Code: 73328
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: 10-03-2019 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: 12-31-2021 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’.

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Wellements Throat Pops Product Label Images

Wellements Throat Pops 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


Drug Facts

* Organically producedChoking hazard: Not for children under 3 years.Manufactured in a facility which processes peanuts, tree nuts and dairy products.Distributed by Wellements®6263 N. Scottsdale Rd., Ste. 125, Scottsdale, AZ 85250Questions: visit wellements.com or call 800-255-2690Certified organic by Organic Certifiers US-ORG043

Otc - Active Ingredient

Active ingredient (in each pop)*Pectin 11.5 mg

Otc - Purpose

PurposeOral Demulcent

Indications & Usage

UsesFor the temporary relief of minor sore throats


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

Otc - Stop Use

  • Stop use and ask a doctor ifsore throat does not improve in 7 daysirritation, pain, or redness persists or worsens

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directions​adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth
  • May be repeated as needed or as directed by a doctorchildren under 3 years of age: ask a doctor

Storage And Handling

Other information store between 65 - 75°F (18 - 24°C)

Inactive Ingredient

Inactive ingredientsbeetroot juice concentrate, citric acid, organic brown rice syrup, organic cane sugar, organic strawberry flavor

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