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Drug Information

Product NDC: 0121-0775

Proprietary Name: Guaifenesin and Codeine Phosphate

Non Proprietary Name: Guaifenesin and Codeine Phosphate

Active Ingredient(s):
  • 100 mg/5mL GUAIFENESIN

Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Decreased Respiratory Secretion Viscosity [PE];
  • Expectorant [EPC];
  • Full Opioid Agonists [MoA];
  • Increased Respiratory Secretions [PE];
  • Opioid Agonist [EPC]

Labeler Information

Labeler Name: Pharmaceutical Associates, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:10/1/2006
DEA Schedule:CV

Package Information

No. Package Code Package Description Billing Unit
10121-0775-04118 mL in 1 BOTTLE (0121-0775-04)ML
20121-0775-08237 mL in 1 BOTTLE (0121-0775-08)ML
30121-0775-16473 mL in 1 BOTTLE (0121-0775-16)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0121-0775The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEGuaifenesin and Codeine PhosphateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGuaifenesin and Codeine PhosphateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/1/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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 under Structured Product Labeling Resources.
APPLICATION NUMBERpart341This 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.
LABELER NAMEPharmaceutical Associates, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECODEINE PHOSPHATE; GUAIFENESINAn 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.
PHARM CLASSESDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC] 
DEA SCHEDULECVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 2/1/2023