hydrocortisone 1%

Generic: hydrocortisone 1%

Labeler: prostat first aid llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone 1%
Generic Name hydrocortisone 1%
Labeler prostat first aid llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
ProStat First Aid LLC

Identifiers & Regulatory

Product NDC 58228-2045
Product ID 58228-2045_46013b99-8359-912c-e063-6294a90a1050
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M032
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

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 582282045
Hyphenated Format 58228-2045

Supplemental Identifiers

RxCUI
106258
UPC
0814889010179
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 1% (source: ndc)
Generic Name hydrocortisone 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 (58228-2045-2) / 25 PACKET in 1 BOX (58228-2045-1) / .9 g in 1 PACKET
source: ndc

Packages (1)

58228-2045-2 1800 BOX in 1 CASE (58228-2045-2) / 25 PACKET in 1 BOX (58228-2045-1) / .9 g in 1 PACKET

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Hydrocortisone 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "46013b99-8359-912c-e063-6294a90a1050", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0814889010179"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["f707bda4-074a-6406-e053-6394a90a7ae1"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ProStat First Aid LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1800 BOX in 1 CASE (58228-2045-2)  / 25 PACKET in 1 BOX (58228-2045-1)  / .9 g in 1 PACKET", "package_ndc": "58228-2045-2", "marketing_start_date": "20230410"}], "brand_name": "Hydrocortisone 1%", "product_id": "58228-2045_46013b99-8359-912c-e063-6294a90a1050", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "58228-2045", "generic_name": "Hydrocortisone 1%", "labeler_name": "ProStat First Aid LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone 1%", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M032", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}