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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0573-2919
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Phenylephrine hydrochloride
Product Specifications
Route of AdministrationRECTAL
Effective DateApril 11, 2025
FDA Product Classification
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