fifthpulse hydrocortisone 4oz

Generic: hydrocortisone

Labeler: front pharmaceutical plc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name fifthpulse hydrocortisone 4oz
Generic Name hydrocortisone
Labeler front pharmaceutical plc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Front Pharmaceutical PLC

Identifiers & Regulatory

Product NDC 69571-015
Product ID 69571-015_39fb29c8-6a29-e87e-e063-6294a90a78da
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2025-07-16

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 69571015
Hyphenated Format 69571-015

Supplemental Identifiers

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 fifthpulse hydrocortisone 4oz (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 113.4 g in 1 TUBE (69571-015-01)
source: ndc

Packages (1)

69571-015-01 113.4 g in 1 TUBE (69571-015-01)

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

FifthPulse Hydrocortisone 4oz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39fb29c8-6a29-e87e-e063-6294a90a78da", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "spl_set_id": ["39fb29c8-6a28-e87e-e063-6294a90a78da"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Front Pharmaceutical PLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113.4 g in 1 TUBE (69571-015-01)", "package_ndc": "69571-015-01", "marketing_start_date": "20250716"}], "brand_name": "FifthPulse Hydrocortisone 4oz", "product_id": "69571-015_39fb29c8-6a29-e87e-e063-6294a90a78da", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69571-015", "generic_name": "Hydrocortisone", "labeler_name": "Front Pharmaceutical PLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FifthPulse Hydrocortisone 4oz", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}