dermacort anti-itch

Generic: hydrocortisone

Labeler: melaleuca, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dermacort anti-itch
Generic Name hydrocortisone
Labeler melaleuca, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Melaleuca, Inc.

Identifiers & Regulatory

Product NDC 54473-117
Product ID 54473-117_30cddb97-469e-d4b1-e063-6394a90a098b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2000-08-02

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 54473117
Hyphenated Format 54473-117

Supplemental Identifiers

RxCUI
106258 206354
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 dermacort anti-itch (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 28 g in 1 TUBE (54473-117-28)
source: ndc

Packages (1)

54473-117-28 28 g in 1 TUBE (54473-117-28)

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

DermaCort Anti-itch ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "30cddb97-469e-d4b1-e063-6394a90a098b", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258", "206354"], "spl_set_id": ["24044b0f-dd1e-4762-82b8-7a28b08c2f77"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Melaleuca, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 g in 1 TUBE (54473-117-28)", "package_ndc": "54473-117-28", "marketing_start_date": "20180101"}], "brand_name": "DermaCort Anti-itch", "product_id": "54473-117_30cddb97-469e-d4b1-e063-6394a90a098b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "54473-117", "generic_name": "Hydrocortisone", "labeler_name": "Melaleuca, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DermaCort", "brand_name_suffix": "Anti-itch", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20000802", "listing_expiration_date": "20261231"}