hydrocortisone

Generic: hydrocortisone

Labeler: henry schein
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler henry schein
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Henry Schein

Identifiers & Regulatory

Product NDC 0404-0166
Product ID 0404-0166_446de5c1-e105-f248-e063-6294a90aa852
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M032
Listing Expiration 2026-12-31
Marketing Start 2022-11-07

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 04040166
Hyphenated Format 0404-0166

Supplemental Identifiers

RxCUI
106258
UPC
0304040166505
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 (source: ndc)
Application Number M032 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 72 BOX in 1 CASE (0404-0166-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE
source: ndc

Packages (1)

0404-0166-50 72 BOX in 1 CASE (0404-0166-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "446de5c1-e105-f248-e063-6294a90aa852", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0304040166505"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["eb031535-d17e-9d5e-e053-2a95a90ad3e0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Henry Schein"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "72 BOX in 1 CASE (0404-0166-50)  / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE", "package_ndc": "0404-0166-50", "marketing_start_date": "20221107"}], "brand_name": "Hydrocortisone", "product_id": "0404-0166_446de5c1-e105-f248-e063-6294a90aa852", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0404-0166", "generic_name": "Hydrocortisone", "labeler_name": "Henry Schein", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M032", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221107", "listing_expiration_date": "20261231"}