NDC 65193-325

Pseudo Ephed Plus

Pseudoephedrine Hydrochloride, Guaifenesin

Pseudo Ephed Plus is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Dickey Consumer Products Dba Dmd. The primary component is Pseudoephedrine Hydrochloride; Guaifenesin.

Product ID65193-325_865da4b2-08e5-4d75-b672-dc1ee6a464bd
NDC65193-325
Product TypeHuman Otc Drug
Proprietary NamePseudo Ephed Plus
Generic NamePseudoephedrine Hydrochloride, Guaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDickey Consumer Products DBA DMD
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN
Active Ingredient Strength30 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65193-325-24

24 TABLET in 1 BLISTER PACK (65193-325-24)
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65193-325-24 [65193032524]

Pseudo Ephed Plus TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:848c680c-22c4-4b43-bc3a-21ff72e88888
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298439
  • UPC Code
  • 0098443222011

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