NDC 0121-1276 Guaifenesin Dm

Guaifenesin Dm with NDC 0121-1276 is a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Guaifenesin Dm is guaifenesin and dextromethorphan. The product's dosage form is syrup and is administered via oral form.

Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.

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.

Guaifenesin Dm 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.

• DEXTROMETHORPHAN 20 mg/10mL
• GUAIFENESIN 200 mg/10mL

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

• RxCUI: 996520

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.

• CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
• FD&C RED NO. 40 (UNII: WZB9127XOA)
• GLYCERIN (UNII: PDC6A3C0OX)
• MENTHOL (UNII: L7T10EIP3A)
• WATER (UNII: 059QF0KO0R)
• SODIUM BENZOATE (UNII: OJ245FE5EU)
• SODIUM CITRATE (UNII: 1Q73Q2JULR)
• SACCHARIN SODIUM (UNII: SB8ZUX40TY)
• SUCROSE (UNII: C151H8M554)
• SODIUM BENZOATE (UNII: OJ245FE5EU)
• SODIUM CITRATE (UNII: 1Q73Q2JULR)
• SACCHARIN SODIUM (UNII: SB8ZUX40TY)
• SUCROSE (UNII: C151H8M554)
• CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
• FD&C RED NO. 40 (UNII: WZB9127XOA)
• GLYCERIN (UNII: PDC6A3C0OX)
• MENTHOL (UNII: L7T10EIP3A)
• WATER (UNII: 059QF0KO0R)

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.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

• Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
• Expectorant - [EPC] (Established Pharmacologic Class)
• Increased Respiratory Secretions - [PE] (Physiologic Effect)
• Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
• Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
• Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
• Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
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: 07-01-1992 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: 12-31-2023 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".

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