hydroxate gel

Generic: hydrocortisone 2%

Labeler: puretek corporation
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxate gel
Generic Name hydrocortisone 2%
Labeler puretek corporation
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

hydrocortisone 20 mg/g

Manufacturer
PureTek Corporation

Identifiers & Regulatory

Product NDC 59088-328
Product ID 59088-328_13bc5f75-b5ca-4d48-e063-6394a90ab608
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2024-03-15

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 59088328
Hyphenated Format 59088-328

Supplemental Identifiers

RxCUI
604449
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 hydroxate gel (source: ndc)
Generic Name hydrocortisone 2% (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 28 g in 1 TUBE (59088-328-03)
source: ndc

Packages (1)

59088-328-03 28 g in 1 TUBE (59088-328-03)

Ingredients (1)

hydrocortisone (20 mg/g)

Linked Drug Pages (1)

Hydroxate Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "13bc5f75-b5ca-4d48-e063-6394a90ab608", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["604449"], "spl_set_id": ["13bc5f75-b5cb-4d48-e063-6394a90ab608"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 g in 1 TUBE (59088-328-03)", "package_ndc": "59088-328-03", "marketing_start_date": "20240315"}], "brand_name": "Hydroxate Gel", "product_id": "59088-328_13bc5f75-b5ca-4d48-e063-6394a90ab608", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "59088-328", "generic_name": "HYDROCORTISONE 2%", "labeler_name": "PureTek Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxate Gel", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "20 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20240315", "listing_expiration_date": "20261231"}