Giltuss Tr Tablet
NDC 58552-355

3 active ingredients · Tablet (oral)
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58552-355?
  5. Giltuss Tr Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

This code was recently added to the official NDC directory and the product has entered commercial distribution.

Giltuss Tr (guaifenesin,dextromethorphan hbr,phenylephrine hcl) is a OTC MONOGRAPH DRUG-approved product labeled by Gil Pharmaceutical Corp. This medication is typically used as a adrenergic alpha1-agonists [moa]. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 58552-355 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58552-355
Proprietary Name:
Giltuss Tr
Non-Proprietary Name: [1]
Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl
Substance Name: [2]
Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Gil Pharmaceutical Corp
Labeler Code:
58552
Product Label ID:
74398f9f-f1a8-4bd5-8fea-c0afc6acc42f
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
10-01-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
15 MM
Imprint(s):
GIL;335
Score:
2

Code Structure Chart

Product Details

What is NDC 58552-355?

The NDC code 58552-355 is assigned by the FDA to the product Giltuss Tr. It is commonly known by its generic name, guaifenesin, dextromethorphan hbr, phenylephrine hcl. This pharmaceutical product is labeled by Gil Pharmaceutical Corp and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 58552-355-01, 58552-355-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Do not exceed recommended doses in a 24 hour periodAdults and Children 12 years and over: 1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours. Children 6 to 12 years: 1/2 tablet every 6 to 8 hours. Do not exceed 2 tablets in 24 hours. Children under 6 years of age: ask a doctor.

What are Active Ingredients of 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.
  • GUAIFENESIN 390 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
  • DEXTROMETHORPHAN HYDROBROMIDE 29 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
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.
What is the Substance Name? 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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".