41250-123 NDC - EFFERVESCENT ORANGE COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE)

Drug Information

Product NDC: 41250-123

Proprietary Name: Effervescent Orange Cold Relief

Non Proprietary Name: Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate

Active Ingredient(s):
  • 325 mg/1 ASPIRIN;
  • 2 mg/1 CHLORPHENIRAMINE MALEATE;
  • 7.8 mg/1 PHENYLEPHRINE BITARTRATE


Administration Route(s): ORAL

Dosage Form(s): TABLET, EFFERVESCENT

Pharmacy Class(es):
  • Adrenergic alpha1-Agonists [MoA];
  • Anti-Inflammatory Agents;
  • Non-Steroidal [CS];
  • Cyclooxygenase Inhibitors [MoA];
  • Decreased Platelet Aggregation [PE];
  • Decreased Prostaglandin Production [PE];
  • Histamine H1 Receptor Antagonists [MoA];
  • Histamine-1 Receptor Antagonist [EPC];
  • Nonsteroidal Anti-inflammatory Drug [EPC];
  • Platelet Aggregation Inhibitor [EPC];
  • alpha-1 Adrenergic Agonist [EPC]

Labeler Information

Labeler Name: Meijer Distribution Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:5/26/2013

Package Information

No. Package Code Package Description Billing Unit
141250-123-2010 POUCH in 1 CARTON (41250-123-20) / 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC41250-123The 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 NAMEEffervescent Orange Cold ReliefThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAspirin, Chlorpheniramine Maleate, Phenylephrine BitartrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, EFFERVESCENTThe 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 DATE5/26/2013This 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 www.fda.gov/edrls 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 NAMEMeijer Distribution Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATEAn 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.
ACTIVE NUMERATOR STRENGTH325; 2; 7.8 
ACTIVE INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC] 

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