preparation h

Generic: cocoa butter, 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 cocoa butter, phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

cocoa butter 2211 mg/1, phenylephrine hydrochloride 6.25 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-2883
Product ID 0573-2883_12ad4740-7bea-f822-e063-6394a90a0e38
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2004-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05732883
Hyphenated Format 0573-2883

Supplemental Identifiers

RxCUI
1438497
UNII
512OYT1CRR 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 cocoa butter, phenylephrine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 2211 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • PRINCIPAL DISPLAY PANEL NDC 0573-2883-10 PREPARATION H ® HEMORRHOIDAL SUPPOSITORIES Reduces Internal Swelling, Soothes and Protects Prompt Soothing Relief from Painful Burning, Itching and Discomfort Shrinks Swollen Hemorrhoidal Tissue Protects Irritated Tissue Also for Nighttime Relief 12 SUPPOSITORIES Principal Display Panel - 12 Suppository Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL NDC 0573-2880-31 PREPARATION H ® HEMORRHOIDAL SUPPOSITORIES Provides Relief from MULTIPLE SYMPTOMS Reduces Internal Swelling, Soothes & Protects Prompt Soothing Relief from Painful Burning, Itching and Discomfort Also for Nighttime Relief #1 SELLING # 1 HEMORRHOID BRAND 48 SUPPOSITORIES Principal Display Panel - 48 Suppository Blister Pack Carton
source: label

Packages (0)

No package records.

Ingredients (2)

cocoa butter (2211 mg/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": "12ad4740-7bea-f822-e063-6394a90a0e38", "openfda": {"unii": ["512OYT1CRR", "04JA59TNSJ"], "rxcui": ["1438497"], "spl_set_id": ["a23ded81-78ba-c199-a8f0-aaf360b216ff"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "PREPARATION H", "product_id": "0573-2883_12ad4740-7bea-f822-e063-6394a90a0e38", "dosage_form": "SUPPOSITORY", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-2883", "generic_name": "cocoa butter, phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PREPARATION H", "active_ingredients": [{"name": "COCOA BUTTER", "strength": "2211 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "6.25 mg/1"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040105", "listing_expiration_date": "20261231"}