71309-110 NDC - SLEEP-EZ NIGHTTIME SLEEP AID ()

Drug Information

  • Product NDC: 71309-110
  • Proprietary Name: Sleep-EZ Nighttime Sleep Aid
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Safrel Pharmaceuticals, LLC.
Product Type:
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:6/1/2017

Package Information

No. Package Code Package Description Billing Unit
171309-110-022 POUCH in 1 POUCH (71309-110-02) / 2 TABLET, COATED in 1 POUCH
271309-110-10100 BOTTLE in 1 BOTTLE (71309-110-10) / 1000 BOTTLE in 1 BOTTLE (71309-110-01) / 500 BOTTLE in 1 BOTTLE (71309-110-05) / 30 CARTON in 1 BOTTLE (71309-110-30) / 1 TABLET, COATED in 1 CARTON
371309-110-2525 POUCH in 1 BOX (71309-110-25) / 2 TABLET, COATED in 1 POUCH
471309-110-5050 POUCH in 1 BOX (71309-110-50) / 2 TABLET, COATED in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC71309-110The 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 NAMESleep-EZ Nighttime Sleep AidThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/1/2017This 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 NAMESafrel Pharmaceuticals, LLC.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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