0363-0050 NDC - NIGHTTIME D ()

Drug Information

  • Product NDC: 0363-0050
  • Proprietary Name: Nighttime D
  • Non Proprietary Name:
  • Active Ingredient(s): 38 mg/1 DIPHENHYDRAMINE CITRATE; 200 mg/1 IBUPROFEN
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Walgreen Company
Product Type:
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:6/26/2002
End Marketing Date:1/25/2012

Package Information

No. Package Code Package Description Billing Unit
10363-0050-271 BOTTLE in 1 CARTON (0363-0050-27) / 80 TABLET, FILM COATED in 1 BOTTLEEA
20363-0050-38296 mL in 1 BOTTLE (0363-0050-38)
30363-0050-481 BOTTLE in 1 CARTON (0363-0050-48) / 180 TABLET, FILM COATED in 1 BOTTLE
40363-0050-581 BOTTLE in 1 CARTON (0363-0050-58) / 40 TABLET, FILM COATED in 1 BOTTLE
50363-0050-601 BOTTLE in 1 CARTON (0363-0050-60) / 20 TABLET, FILM COATED in 1 BOTTLEEA
60363-0050-761 BOTTLE in 1 CARTON (0363-0050-76) / 120 TABLET, FILM COATED in 1 BOTTLEEA
70363-0050-82200 TABLET, FILM COATED in 1 BOTTLE (0363-0050-82)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-0050The 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.
PROPRIETARY NAMENighttime DThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/26/2002This 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 NAMEWalgreen CompanyName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0363-0050The 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.
PROPRIETARY NAMEIbuprofen PMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/19/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA079113This 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 NAMEWalgreen CompanyName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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