0113-6044 NDC - GOOD SENSE SLEEP AID ULTRA (DOXYLAMINE SUCCINATE)

Drug Information

  • Product NDC: 0113-6044
  • Proprietary Name: good sense sleep aid ultra
  • Non Proprietary Name: Doxylamine Succinate
  • Active Ingredient(s): 25 mg/1 DOXYLAMINE SUCCINATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Antihistamine [EPC]; Histamine Receptor Antagonists [MoA]

Labeler Information

Field Name Field Value
Labeler Name: L. Perrigo Company
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA040167
Marketing Category: ANDA
Start Marketing Date:8/6/2022

Package Information

No. Package Code Package Description Billing Unit
10113-6044-6748 BLISTER PACK in 1 CARTON (0113-6044-67) / 1 TABLET in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0113-6044The 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 NAMEgood sense sleep aid ultraThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDoxylamine SuccinateThe 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 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.
START MARKETING DATE8/6/2022Indicates 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.
MARKETING CATEGORY NAMEANDAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBERANDA040167The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAMEL. Perrigo CompanyThe translation of the dosage form Code submitted by the firm.
SUBSTANCE NAMEDOXYLAMINE SUCCINATEThe translation of the route code submitted by the firm, indicating route of administration.
ACTIVE NUMERATOR STRENGTH25 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAntihistamine [EPC], Histamine Receptor Antagonists [MoA] 

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This page was last updated on: 12/19/2025

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