NDC 12546-341 Halls Extra Strong Menthol Menthol

Menthol

NDC Product Code 12546-341

NDC Product Information

Halls Extra Strong Menthol Menthol with NDC 12546-341 is a a human over the counter drug product labeled by Mondelez Global Llc. The generic name of Halls Extra Strong Menthol Menthol is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Mondelez Global 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.

Halls Extra Strong Menthol Menthol 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.

  • MENTHOL 20 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POTASSIUM CITRATE (UNII: EE90ONI6FF)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)
  • 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: Mondelez Global Llc
Labeler Code: 12546
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: 07-26-2019 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.

Halls Extra Strong Menthol Menthol Product Label Images

Halls Extra Strong Menthol Menthol 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

Active Ingredients

<(per drop) Menthol 20 mg>

Purposes


Uses

-sore throat-sore mouth

Warnings


Stop Use And Ask A Doctor If

  • Sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens

Directions

  • Adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.children under 5 years: ask a doctor

Other Information

  • 10 calories per dropContains: SOY.

Inactive Ingredients


Questions


* Please review the disclaimer below.

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