hydrocortisone cream 1%

Generic: hydrocortisone cream 1%

Labeler: front line safety
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone cream 1%
Generic Name hydrocortisone cream 1%
Labeler front line safety
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Front Line Safety

Identifiers & Regulatory

Product NDC 58228-6245
Product ID 58228-6245_46017470-c3c9-f7c5-e063-6294a90aef80
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M032
Listing Expiration 2026-12-31
Marketing Start 2024-01-26

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 582286245
Hyphenated Format 58228-6245

Supplemental Identifiers

RxCUI
106258
UPC
0814889014894
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 cream 1% (source: ndc)
Generic Name hydrocortisone cream 1% (source: ndc)
Application Number M032 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1800 BOX in 1 CASE (58228-6245-1) / 25 PACKET in 1 BOX / .9 g in 1 PACKET
source: ndc

Packages (1)

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "46017470-c3c9-f7c5-e063-6294a90aef80", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0814889014894"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["0f4ede34-7e70-789e-e063-6394a90a72a4"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Front Line Safety"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1800 BOX in 1 CASE (58228-6245-1)  / 25 PACKET in 1 BOX / .9 g in 1 PACKET", "package_ndc": "58228-6245-1", "marketing_start_date": "20240126"}], "brand_name": "Hydrocortisone Cream 1%", "product_id": "58228-6245_46017470-c3c9-f7c5-e063-6294a90aef80", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "58228-6245", "generic_name": "Hydrocortisone Cream 1%", "labeler_name": "Front Line Safety", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone Cream 1%", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M032", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240126", "listing_expiration_date": "20261231"}