hydrocortisone

Generic: hydrocortisone

Labeler: safetec of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler safetec of america, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-5800
Product ID 61010-5800_10d3fc91-82ae-e8eb-e063-6394a90ae87b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2010-12-15

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 610105800
Hyphenated Format 61010-5800

Supplemental Identifiers

RxCUI
106258
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 M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 144 POUCH in 1 BOX (61010-5800-2) / .9 g in 1 POUCH (61010-5800-1)
  • 25 POUCH in 1 BOX (61010-5800-3) / .9 g in 1 POUCH (61010-5800-1)
  • 10 POUCH in 1 BOX (61010-5800-4) / .9 g in 1 POUCH (61010-5800-1)
source: ndc

Packages (3)

61010-5800-2 144 POUCH in 1 BOX (61010-5800-2) / .9 g in 1 POUCH (61010-5800-1) 61010-5800-3 25 POUCH in 1 BOX (61010-5800-3) / .9 g in 1 POUCH (61010-5800-1) 61010-5800-4 10 POUCH in 1 BOX (61010-5800-4) / .9 g in 1 POUCH (61010-5800-1)

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "10d3fc91-82ae-e8eb-e063-6394a90ae87b", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["da2b3b2c-11e0-401b-bbd2-d019271d1b3d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 POUCH in 1 BOX (61010-5800-2)  / .9 g in 1 POUCH (61010-5800-1)", "package_ndc": "61010-5800-2", "marketing_start_date": "20101215"}, {"sample": false, "description": "25 POUCH in 1 BOX (61010-5800-3)  / .9 g in 1 POUCH (61010-5800-1)", "package_ndc": "61010-5800-3", "marketing_start_date": "20101215"}, {"sample": false, "description": "10 POUCH in 1 BOX (61010-5800-4)  / .9 g in 1 POUCH (61010-5800-1)", "package_ndc": "61010-5800-4", "marketing_start_date": "20200401"}], "brand_name": "Hydrocortisone", "product_id": "61010-5800_10d3fc91-82ae-e8eb-e063-6394a90ae87b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "61010-5800", "generic_name": "Hydrocortisone", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20101215", "listing_expiration_date": "20261231"}