| PRODUCT NDC | 0280-0069 | 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. |
| PRODUCT TYPE NAME | HUMAN OTC DRUG | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| PROPRIETARY NAME | Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | 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. |
| NON PROPRIETARY NAME | aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | KIT | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 8/5/2021 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | OTC MONOGRAPH FINAL | 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. |
| APPLICATION NUMBER | part341 | 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. |
| LABELER NAME | Bayer HealthCare LLC. | Name of Company corresponding to the labeler code segment of the Product NDC. |