NDC 12546-101 Halls Ice Peppermint
Menthol Lozenge Oral

Product Information

What is NDC 12546-101?

The NDC code 12546-101 is assigned by the FDA to the product Halls Ice Peppermint which is a human over the counter drug product labeled by Mondelez Global Llc. The generic name of Halls Ice Peppermint is menthol. The product's dosage form is lozenge and is administered via oral form. The product is distributed in a single package with assigned NDC code 12546-101-09 9 lozenge in 1 package . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code12546-101
Proprietary Name 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.
Halls Ice Peppermint
Non-Proprietary Name 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.
Menthol
Product Type 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.
Human Otc Drug
Dosage FormLozenge - 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.
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.
Mondelez Global Llc
Labeler Code12546
FDA Application Number 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.
part341
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-07-2019
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Halls Ice Peppermint?


Product Characteristics

Color(s)BLUE (C48333 - AQUA WITH BLUE GLITTER)
ShapeSQUARE (C48350)
Size(s)21 MM
Imprint(s)H
Score1
Flavor(s)PEPPERMINT (C73408 - ICE PEPPERMINT)

Product Packages

NDC Code 12546-101-09

Package Description: 9 LOZENGE in 1 PACKAGE

Product Details

What are Halls Ice Peppermint Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Halls Ice Peppermint Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Halls Ice Peppermint Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Halls Ice Peppermint Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



<(per drop) Menthol 10 mg>


Purposes



<Cough suppressant, Oral anesthetic>


Indications & Usage



<temporarily relieves:>

  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings



<Sore 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.>


Ask A Doctor Before Use If You Have



  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If



  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache.  These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep Out Of Reach Of Children.



Enter section text here


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



  • 15 calories per drop
  • Contains: SOY.

Inactive Ingredients



<eucalyptus oil, FDC blue 1, flavors, glucose syrup, soy lecithin, sucrose, water>


Questions?



<Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>


Otc Principal Display Panel



<NDC 12546-101-09 Halls Ice Peppermint 9ct stick>


* Please review the disclaimer below.