hydrocortisone

Generic: hydrocortisone

Labeler: allied trade link llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler allied trade link llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
ALLIED TRADE LINK LLC

Identifiers & Regulatory

Product NDC 84387-005
Product ID 84387-005_26bc238d-3bdb-0c29-e063-6394a90a35fb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-11-12

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 84387005
Hyphenated Format 84387-005

Supplemental Identifiers

RxCUI
106258
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 hydrocortisone (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
  • 28.4 g in 1 TUBE (84387-005-01)
source: ndc

Packages (1)

84387-005-01 28.4 g in 1 TUBE (84387-005-01)

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

HYDROCORTISONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "26bc238d-3bdb-0c29-e063-6394a90a35fb", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["26bc238d-3bda-0c29-e063-6394a90a35fb"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ALLIED TRADE LINK LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (84387-005-01)", "package_ndc": "84387-005-01", "marketing_start_date": "20241112"}], "brand_name": "HYDROCORTISONE", "product_id": "84387-005_26bc238d-3bdb-0c29-e063-6394a90a35fb", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "84387-005", "generic_name": "HYDROCORTISONE", "labeler_name": "ALLIED TRADE LINK LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "HYDROCORTISONE", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241112", "listing_expiration_date": "20261231"}