preparation h

Generic: mineral oil, petrolatum, phenylephrine hcl

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 mineral oil, petrolatum, phenylephrine hcl
Labeler haleon us holdings llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

mineral oil 140 mg/g, petrolatum 749 mg/g, phenylephrine hydrochloride 2.5 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-2871
Product ID 0573-2871_128ba16d-dbb2-1073-e063-6394a90a8ba6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2004-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05732871
Hyphenated Format 0573-2871

Supplemental Identifiers

RxCUI
1372298
UNII
T5L8T28FGP 4T6H12BN9U 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 mineral oil, petrolatum, phenylephrine hcl (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 140 mg/g
  • 749 mg/g
  • 2.5 mg/g
source: ndc
Packaging
  • 2 CARTON in 1 PACKAGE (0573-2871-04) / 1 TUBE in 1 CARTON / 57 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2871-10) / 28 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2871-20) / 57 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2871-91) / 28 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2871-92) / 57 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2871-93) / 28 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2871-94) / 57 g in 1 TUBE
source: ndc

Packages (7)

0573-2871-04 2 CARTON in 1 PACKAGE (0573-2871-04) / 1 TUBE in 1 CARTON / 57 g in 1 TUBE 0573-2871-10 1 TUBE in 1 CARTON (0573-2871-10) / 28 g in 1 TUBE 0573-2871-20 1 TUBE in 1 CARTON (0573-2871-20) / 57 g in 1 TUBE 0573-2871-91 1 TUBE in 1 CARTON (0573-2871-91) / 28 g in 1 TUBE 0573-2871-92 1 TUBE in 1 CARTON (0573-2871-92) / 57 g in 1 TUBE 0573-2871-93 1 TUBE in 1 CARTON (0573-2871-93) / 28 g in 1 TUBE 0573-2871-94 1 TUBE in 1 CARTON (0573-2871-94) / 57 g in 1 TUBE

Ingredients (3)

mineral oil (140 mg/g) petrolatum (749 mg/g) phenylephrine hydrochloride (2.5 mg/g)

Linked Drug Pages (1)

PREPARATION H ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "128ba16d-dbb2-1073-e063-6394a90a8ba6", "openfda": {"unii": ["T5L8T28FGP", "4T6H12BN9U", "04JA59TNSJ"], "rxcui": ["1372298"], "spl_set_id": ["507c08ab-a98b-33fe-e2ac-eb9b9a810d5a"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 PACKAGE (0573-2871-04)  / 1 TUBE in 1 CARTON / 57 g in 1 TUBE", "package_ndc": "0573-2871-04", "marketing_start_date": "20040301"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2871-10)  / 28 g in 1 TUBE", "package_ndc": "0573-2871-10", "marketing_start_date": "20040301"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2871-20)  / 57 g in 1 TUBE", "package_ndc": "0573-2871-20", "marketing_start_date": "20040301"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2871-91)  / 28 g in 1 TUBE", "package_ndc": "0573-2871-91", "marketing_start_date": "20180301"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2871-92)  / 57 g in 1 TUBE", "package_ndc": "0573-2871-92", "marketing_start_date": "20180301"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2871-93)  / 28 g in 1 TUBE", "package_ndc": "0573-2871-93", "marketing_start_date": "20190601"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2871-94)  / 57 g in 1 TUBE", "package_ndc": "0573-2871-94", "marketing_start_date": "20200517"}], "brand_name": "PREPARATION H", "product_id": "0573-2871_128ba16d-dbb2-1073-e063-6394a90a8ba6", "dosage_form": "OINTMENT", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-2871", "generic_name": "mineral oil, petrolatum, phenylephrine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PREPARATION H", "active_ingredients": [{"name": "MINERAL OIL", "strength": "140 mg/g"}, {"name": "PETROLATUM", "strength": "749 mg/g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040301", "listing_expiration_date": "20261231"}