0280-4100 NDC - ALKA-SELTZER GOLD

Drug Information

Product NDC: 0280-4100

Proprietary Name: Alka-Seltzer Gold

Non Proprietary Name: Alka-Seltzer Gold

Active Ingredient(s):
  • 1000 mg/1 CITRIC ACID MONOHYDRATE;
  • 344 mg/1 POTASSIUM BICARBONATE;
  • 1050 mg/1 SODIUM BICARBONATE


Administration Route(s): ORAL

Dosage Form(s): TABLET, EFFERVESCENT

Pharmacy Class(es):
  • Acidifying Activity [MoA];
  • Anti-coagulant [EPC];
  • Calcium Chelating Activity [MoA];
  • Calculi Dissolution Agent [EPC];
  • Decreased Coagulation Factor Activity [PE];
  • Increased Large Intestinal Motility [PE];
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Osmotic Activity [MoA];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Osmotic Laxative [EPC];
  • Potassium Compounds [CS];
  • Potassium Salt [EPC]

Labeler Information

Labeler Name: Bayer HealthCare LLC.
Product Type: HUMAN OTC DRUG
FDA Application Number: part331
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:11/19/2014

Package Information

No. Package Code Package Description Billing Unit
10280-4100-6318 POUCH in 1 CARTON (0280-4100-63) / 2 TABLET, EFFERVESCENT in 1 POUCHEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0280-4100The 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 NAMEAlka-Seltzer GoldThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAlka-Seltzer GoldThe 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 DATE11/19/2014This 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 NUMBERpart331This 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 NAMEBayer HealthCare LLC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECITRIC ACID MONOHYDRATE; POTASSIUM BICARBONATE; SODIUM BICARBONATEAn 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 STRENGTH1000; 344; 1050 
ACTIVE INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAcidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC] 

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