preparation h maximum strength

Generic: glycerin, petrolatum, phenylephrine hcl, pramoxine hcl

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

Drug Facts

Product Profile

Brand Name preparation h maximum strength
Generic Name glycerin, petrolatum, phenylephrine hcl, pramoxine hcl
Labeler haleon us holdings llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 144 mg/g, petrolatum 150 mg/g, phenylephrine hydrochloride 2.5 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-2868
Product ID 0573-2868_15581b30-e814-550a-e063-6394a90a3aae
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2004-07-01

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05732868
Hyphenated Format 0573-2868

Supplemental Identifiers

RxCUI
1293649
UNII
PDC6A3C0OX 4T6H12BN9U 04JA59TNSJ 88AYB867L5
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

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 maximum strength (source: ndc)
Generic Name glycerin, petrolatum, phenylephrine hcl, pramoxine hcl (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 144 mg/g
  • 150 mg/g
  • 2.5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0573-2868-10) / 26 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2868-20) / 51 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2868-93) / 26 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0573-2868-98) / 51 g in 1 TUBE
source: ndc

Packages (4)

0573-2868-10 1 TUBE in 1 CARTON (0573-2868-10) / 26 g in 1 TUBE 0573-2868-20 1 TUBE in 1 CARTON (0573-2868-20) / 51 g in 1 TUBE 0573-2868-93 1 TUBE in 1 CARTON (0573-2868-93) / 26 g in 1 TUBE 0573-2868-98 1 TUBE in 1 CARTON (0573-2868-98) / 51 g in 1 TUBE

Ingredients (4)

glycerin (144 mg/g) petrolatum (150 mg/g) phenylephrine hydrochloride (2.5 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

PREPARATION H Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "15581b30-e814-550a-e063-6394a90a3aae", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["7cc03d2e-e708-589a-d9bb-58ebbda989c0"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0573-2868-10)  / 26 g in 1 TUBE", "package_ndc": "0573-2868-10", "marketing_start_date": "20040701"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2868-20)  / 51 g in 1 TUBE", "package_ndc": "0573-2868-20", "marketing_start_date": "20040701"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2868-93)  / 26 g in 1 TUBE", "package_ndc": "0573-2868-93", "marketing_start_date": "20190101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0573-2868-98)  / 51 g in 1 TUBE", "package_ndc": "0573-2868-98", "marketing_start_date": "20200512"}], "brand_name": "PREPARATION H Maximum Strength", "product_id": "0573-2868_15581b30-e814-550a-e063-6394a90a3aae", "dosage_form": "CREAM", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-2868", "generic_name": "glycerin, petrolatum, phenylephrine HCl, pramoxine HCl", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PREPARATION H", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "GLYCERIN", "strength": "144 mg/g"}, {"name": "PETROLATUM", "strength": "150 mg/g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040701", "listing_expiration_date": "20261231"}