NDC 55758-301 Sanatos Lozenges

Menthol

NDC Product Code 55758-301

NDC Code: 55758-301

Proprietary Name: Sanatos Lozenges Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 55758 - Pharmadel Llc
    • 55758-301 - Sanatos Lozenges

NDC 55758-301-05

Package Description: 5 BAG in 1 CARTON > 1 LOZENGE in 1 BAG (55758-301-25)

NDC 55758-301-25

Package Description: 1 LOZENGE in 1 BAG

NDC Product Information

Sanatos Lozenges with NDC 55758-301 is a a human over the counter drug product labeled by Pharmadel Llc. The generic name of Sanatos Lozenges is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Pharmadel 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 Additional informationCallout TooltipWhat 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.


Sanatos Lozenges Active Ingredient(s)

Additional informationCallout TooltipWhat 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 5.5 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)
  • HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • GREATER GALANGAL (UNII: 7Y64R856MB)
  • SUCROSE (UNII: C151H8M554)
  • LONG PEPPER (UNII: 2NMG4EA7B1)
  • CORDIA DICHOTOMA FRUIT (UNII: R4RI8646ZR)
  • LICORICE (UNII: 61ZBX54883)
  • HONEY (UNII: Y9H1V576FH)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmadel Llc
Labeler Code: 55758
FDA Application Number: part341 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-28-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Sanatos Lozenges Product Label Images

Sanatos Lozenges 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 - Purpose

Active ingredients (in each lozenge) PurposesMenthol 5.5 mg................................................ Cough suppressant / oral anesthetic

Uses

  • For the temporary relief ofminor irritation and sore throatscough as may occur with a cold

Warnings

Sore throat warning: if sore throat is severe persists for more than 2 days, is accompanied or followed by high fever, headache, rash, 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 emphysemaa cough that is accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If

  • A cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Directions

  • Adult and children 3 to under 12 years of age: allow the lozenge to dissolve one (1) drop slowly in mouth
  • Repeat every 2 hours as needed or as directed by doctorchildren under 3 years of age: consult a doctor

Other Information

  • Store in cool dry place below 77º Fprotect from heat and lightdo not use if package is torn or broken

Inactive Ingredients

Ascorbic acid, citric acid monohydrate, cordia dichotoma fruit, corn syrup, eucalyptus oil, hyssopus officinalis flowering top, greater galangal, justicia adhatoda leaf, licorice, long pepper, natural honey flavor, natural lemon flavor, sucrose.

* Please review the disclaimer below.

Previous Code
55758-253
Next Code
55758-303