NDC 54305-436 Berry Medley Throat Drops


NDC Product Code 54305-436

NDC CODE: 54305-436

Proprietary Name: Berry Medley Throat Drops 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: Menthol 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.

Product Characteristics

Shape: OVAL (C48345)
24 MM
Score: 1

NDC Code Structure

NDC 54305-436-10

Package Description: 10 LOZENGE in 1 BAG

NDC 54305-436-19

Package Description: 19 LOZENGE in 1 BAG

NDC 54305-436-45

Package Description: 45 LOZENGE in 1 BAG

NDC Product Information

Berry Medley Throat Drops with NDC 54305-436 is a a human over the counter drug product labeled by Ricola Ag. The generic name of Berry Medley Throat Drops is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Ricola Ag

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.

Berry Medley Throat Drops 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 1.7 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.

Product Labeler Information

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

Labeler Name: Ricola Ag
Labeler Code: 54305
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: 05-17-2021 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: 12-31-2022 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 - NO 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.

Berry Medley Throat Drops Product Label Images

Berry Medley Throat Drops 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

PurposeOral anesthetic

Active Ingredient (In Each Drop)

Menthol, 1.7 mg


  • Temporarily
  • Relieves occasional minor irritation and pain associated with:sore mouthsore throat


  • Do not usein children under 6 years of age unless directed by a doctor.

Stop Use And Ask A Doctor If

  • Sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting.sore mouth symptoms do not improve in 7 days.


  • Adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Do not bite or chew.  Repeat every 2 hours as needed or as directed by a doctorchildren under 6 years: ask a doctor

Other Information

Protect from heat and moisture

Inactive Ingredients

Bilberry juice concentrate, black currant juice concentrate, citric acid, extract of Ricola herb mixture (lemon balm, peppermint, thyme, hyssop, sage, elder, linden, mallow, horehound, wild thyme), glucose syrup, natural color, natural flavors, peppermint oil, raspberry juice concentrate, sugar

* Please review the disclaimer below.