hydrocortisone

Generic: hydrocortisone continuous spray

Labeler: premier brands of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone continuous spray
Labeler premier brands of america, inc.
Dosage Form AEROSOL, SPRAY
Routes
TOPICAL
Active Ingredients

hydrocortisone 1.13 g/113g

Manufacturer
Premier Brands of America, Inc.

Identifiers & Regulatory

Product NDC 56104-250
Product ID 56104-250_422b3418-94ea-ea94-e063-6294a90ac334
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2021-12-20

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 56104250
Hyphenated Format 56104-250

Supplemental Identifiers

RxCUI
317564
UPC
0850037540013
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 continuous spray (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.13 g/113g
source: ndc
Packaging
  • 113 g in 1 CAN (56104-250-00)
source: ndc

Packages (1)

56104-250-00 113 g in 1 CAN (56104-250-00)

Ingredients (1)

hydrocortisone (1.13 g/113g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "422b3418-94ea-ea94-e063-6294a90ac334", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0850037540013"], "unii": ["WI4X0X7BPJ"], "rxcui": ["317564"], "spl_set_id": ["d344f68b-9b62-3029-e053-2995a90a1665"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Premier Brands of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 CAN (56104-250-00)", "package_ndc": "56104-250-00", "marketing_start_date": "20211220"}], "brand_name": "Hydrocortisone", "product_id": "56104-250_422b3418-94ea-ea94-e063-6294a90ac334", "dosage_form": "AEROSOL, SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "56104-250", "generic_name": "Hydrocortisone Continuous Spray", "labeler_name": "Premier Brands of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1.13 g/113g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211220", "listing_expiration_date": "20261231"}