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 0573-1378
Product ID 0573-1378_331041bf-cde7-dceb-e063-6394a90a65e0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2022-12-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05731378
Hyphenated Format 0573-1378

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
  • 48 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACK
  • 12 BLISTER PACK in 1 CARTON (0573-1378-01) / 1 SUPPOSITORY in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (0573-1378-06) / 1 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (3)

0573-1378-00 48 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACK 0573-1378-01 12 BLISTER PACK in 1 CARTON (0573-1378-01) / 1 SUPPOSITORY in 1 BLISTER PACK 0573-1378-06 24 BLISTER PACK in 1 CARTON (0573-1378-06) / 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": "331041bf-cde7-dceb-e063-6394a90a65e0", "openfda": {"unii": ["04JA59TNSJ"], "spl_set_id": ["96d2e0e7-2de0-4660-9ffd-9edb2ad224d8"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "48 BLISTER PACK in 1 CARTON (0573-1378-00)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0573-1378-00", "marketing_start_date": "20221216"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0573-1378-01)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0573-1378-01", "marketing_start_date": "20221216"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (0573-1378-06)  / 1 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "0573-1378-06", "marketing_start_date": "20221216"}], "brand_name": "PREPARATION H", "product_id": "0573-1378_331041bf-cde7-dceb-e063-6394a90a65e0", "dosage_form": "SUPPOSITORY", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-1378", "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": "20221216", "listing_expiration_date": "20261231"}