Drug Information

Product NDC: 52301-303

Proprietary Name: Formula 303

Non Proprietary Name: Valerian Root, Passiflora, Magnesium Carbonate

Active Ingredient(s):
  • 1 [hp_X]/[hp_X] MAGNESIUM CARBONATE;
  • 6 [hp_X]/[hp_X] VALERIAN

Administration Route(s): ORAL

Dosage Form(s): TABLET

Labeler Information

Labeler Name: Dee Cee Laboratories
Product Type: HUMAN OTC DRUG
FDA Application Number:
Start Marketing Date:9/19/1990

Package Information

No. Package Code Package Description Billing Unit
152301-303-12120 [hp_X] in 1 BOTTLE (52301-303-12)
252301-303-2112 [hp_X] in 1 BAG (52301-303-21)
352301-303-25250 [hp_X] in 1 BOTTLE (52301-303-25)
452301-303-30300 [hp_X] in 1 BOTTLE (52301-303-30)
552301-303-4545 [hp_X] in 1 BOTTLE (52301-303-45)
652301-303-6060 [hp_X] in 1 BOTTLE (52301-303-60)
752301-303-9090 [hp_X] in 1 BOTTLE (52301-303-90)

NDC Record

Field Name Field Value Definition
PRODUCT NDC52301-303The 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 NAMEFormula 303The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEValerian Root, Passiflora, Magnesium CarbonateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE9/19/1990This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMEDee Cee LaboratoriesName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIANThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE INGRED UNIT[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] 

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This page was last updated on: 10/4/2019