NDC 72628-111 Natural Herbal Cough Drops


NDC Product Code 72628-111

NDC CODE: 72628-111

Proprietary Name: Natural Herbal Cough 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

BROWN (C48332 - DARK)
Shape: OVAL (C48345)
25 MM

NDC Code Structure

  • 72628 - Boston Nutraceutical Production, S.l

NDC 72628-111-01

Package Description: 50 PASTILLE in 1 BAG

NDC Product Information

Natural Herbal Cough Drops with NDC 72628-111 is a a human over the counter drug product labeled by Boston Nutraceutical Production, S.l. The generic name of Natural Herbal Cough Drops is menthol. The product's dosage form is pastille and is administered via oral form.

Labeler Name: Boston Nutraceutical Production, S.l

Dosage Form: Pastille - An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.

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.

Natural Herbal Cough 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 4.8 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.

  • SAGE (UNII: 065C5D077J)
  • 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: Boston Nutraceutical Production, S.l
Labeler Code: 72628
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-12-2021 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.

Natural Herbal Cough Drops Product Label Images

Natural Herbal Cough 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

Otc - Active Ingredient

Active Ingredient in each drop PurposesMenthol 4.8 mgCough SuppressantOral Anesthetic

Otc - Purpose

  • PurposesTemporarily relieves :cough as may occur with a coldoccasional minor irritation and sore throat

Indications & Usage

  • PurposesTemporarily relieves :cough as may occur with a coldoccasional minor irritation and sore throat


WarningsSore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious

Otc - Ask Doctor

  • Ask a doctor before use if you havePersistent or chronic cough such as occurs with smoking, asthma or ephysema.Cough accompanied by excessive pleghm (mucus)

Otc - Stop Use

  • Stop use and consult doctor ifcough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditionssore throat is severe or irritation, pain or redness lasts or worsens.sore mouth does not improve in 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.


In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsAdults and children 6 years and over: allow 2 drops to dissolve slowly in mouth one at a time. Maybe repeated every two hours as needed or as directed by a doctor.Children under 6 years ask a doctor

Other Safety Information

  • Other informationStore in a cool and dry place11 calories per drop

Inactive Ingredient

Glucose syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours

Otc - Questions

Questions or to report an adverse event call:1 800 632 6800

* Please review the disclaimer below.