preparation h hydrocortisone

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name preparation h hydrocortisone
Generic Name hydrocortisone
Labeler haleon us holdings llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-2830
Product ID 0573-2830_128ad543-e543-6322-e063-6294a90a2743
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2004-01-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05732830
Hyphenated Format 0573-2830

Supplemental Identifiers

RxCUI
310868
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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 hydrocortisone (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0573-2830-10) / 26 g in 1 TUBE
source: ndc

Packages (1)

0573-2830-10 1 TUBE in 1 CARTON (0573-2830-10) / 26 g in 1 TUBE

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

PREPARATION H HYDROCORTISONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "128ad543-e543-6322-e063-6294a90a2743", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310868"], "spl_set_id": ["b8d531eb-4012-0450-0e4b-70a808464041"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0573-2830-10)  / 26 g in 1 TUBE", "package_ndc": "0573-2830-10", "marketing_start_date": "20040101"}], "brand_name": "PREPARATION H HYDROCORTISONE", "product_id": "0573-2830_128ad543-e543-6322-e063-6294a90a2743", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0573-2830", "generic_name": "hydrocortisone", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PREPARATION H HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040101", "listing_expiration_date": "20261231"}