PREPARATION H
Drug Facts
Approved
Approval ID
40fde50a-3cc0-4286-9b33-8f3912254c33
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 11, 2025
Manufacturers
FDA
Haleon US Holdings LLC
DUNS: 079944263
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenylephrine hydrochloride
PRODUCT DETAILS
NDC Product Code0573-2919
Application NumberM015
Marketing CategoryC200263
Route of AdministrationRECTAL
Effective DateApril 11, 2025
Generic NamePhenylephrine hydrochloride
INGREDIENTS (5)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
COCOA BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB