preparation h

Generic: phenylephrine hydrochloride

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name preparation h
Generic Name phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

phenylephrine hydrochloride 6.25 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-2919
Product ID 0573-2919_463eea99-6d71-9757-e063-6294a90a668f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-04-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05732919
Hyphenated Format 0573-2919

Supplemental Identifiers

UNII
04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name preparation h (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (0573-2919-12) / 1 SUPPOSITORY in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (0573-2919-24) / 1 SUPPOSITORY in 1 BLISTER PACK
  • 48 BLISTER PACK in 1 CARTON (0573-2919-48) / 1 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (3)

0573-2919-12 12 BLISTER PACK in 1 CARTON (0573-2919-12) / 1 SUPPOSITORY in 1 BLISTER PACK 0573-2919-24 24 BLISTER PACK in 1 CARTON (0573-2919-24) / 1 SUPPOSITORY in 1 BLISTER PACK 0573-2919-48 48 BLISTER PACK in 1 CARTON (0573-2919-48) / 1 SUPPOSITORY in 1 BLISTER PACK

Ingredients (1)

phenylephrine hydrochloride (6.25 mg/1)

Linked Drug Pages (1)

PREPARATION H ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "463eea99-6d71-9757-e063-6294a90a668f", "openfda": {"unii": ["04JA59TNSJ"], "spl_set_id": ["40fde50a-3cc0-4286-9b33-8f3912254c33"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0573-2919-12)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0573-2919-12", "marketing_start_date": "20250430"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (0573-2919-24)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0573-2919-24", "marketing_start_date": "20251101"}, {"sample": false, "description": "48 BLISTER PACK in 1 CARTON (0573-2919-48)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0573-2919-48", "marketing_start_date": "20251101"}], "brand_name": "PREPARATION H", "product_id": "0573-2919_463eea99-6d71-9757-e063-6294a90a668f", "dosage_form": "SUPPOSITORY", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-2919", "generic_name": "Phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PREPARATION H", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "6.25 mg/1"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250430", "listing_expiration_date": "20261231"}