NDC 12546-313 Halls Sugar Free Extra Strong Menthol

NDC Product Code 12546-313

NDC CODE: 12546-313

Proprietary Name: Halls Sugar Free Extra Strong Menthol 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.

NDC Code Structure

NDC 12546-313-02

Package Description: 2 LOZENGE in 1 PACKAGE

NDC 12546-313-25

Package Description: 25 LOZENGE in 1 BAG

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Halls Sugar Free Extra Strong Menthol with NDC 12546-313 is a product labeled by Mondelez Global Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1421441 and 1421443.

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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ASPARTAME (UNII: Z0H242BBR1)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ISOMALT (UNII: S870P55O2W)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • WATER (UNII: 059QF0KO0R)

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
Start Marketing Date: 09-12-2016 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Halls Sugar Free Extra Strong Menthol Product Label Images

Halls Sugar Free Extra Strong 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 Ingredient

<(per drop) 15 mg>

Purpose


Uses

Warnings


Stop Use And Ask A Doctor If

  • Sore mouth does not improve in 7 daysirritation, 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

  • Phenylaketonurics: contains phenylalanine 2 mg per dropexcessive consumption may have a laxative effect5 calories per dropcontains: SOY.

Inactive Ingredients


Questons


* Please review the disclaimer below.