hydrocortisone

Generic: hydrocortisone

Labeler: acme united corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone
Labeler acme united corporation
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Acme United Corporation

Identifiers & Regulatory

Product NDC 0924-1133
Product ID 0924-1133_26bc4721-ef08-2542-e063-6394a90a5642
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-05-08

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 09241133
Hyphenated Format 0924-1133

Supplemental Identifiers

RxCUI
106258
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

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
  • .9 g in 1 POUCH (0924-1133-00)
  • 10 POUCH in 1 BOX (0924-1133-01) / .9 g in 1 POUCH
  • 12 POUCH in 1 BOX (0924-1133-02) / .9 g in 1 POUCH
  • 20 POUCH in 1 BOX (0924-1133-03) / .9 g in 1 POUCH
  • 25 POUCH in 1 BOX (0924-1133-04) / .9 g in 1 POUCH
  • 100 POUCH in 1 BOX (0924-1133-05) / .9 g in 1 POUCH
  • 144 POUCH in 1 BOX (0924-1133-06) / .9 g in 1 POUCH
source: ndc

Packages (7)

0924-1133-00 .9 g in 1 POUCH (0924-1133-00) 0924-1133-01 10 POUCH in 1 BOX (0924-1133-01) / .9 g in 1 POUCH 0924-1133-02 12 POUCH in 1 BOX (0924-1133-02) / .9 g in 1 POUCH 0924-1133-03 20 POUCH in 1 BOX (0924-1133-03) / .9 g in 1 POUCH 0924-1133-04 25 POUCH in 1 BOX (0924-1133-04) / .9 g in 1 POUCH 0924-1133-05 100 POUCH in 1 BOX (0924-1133-05) / .9 g in 1 POUCH 0924-1133-06 144 POUCH in 1 BOX (0924-1133-06) / .9 g in 1 POUCH

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": "26bc4721-ef08-2542-e063-6394a90a5642", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["fabcaa3b-d189-bd29-e053-6294a90ae86b"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Acme United Corporation"]}, "finished": true, "packaging": [{"sample": false, "description": ".9 g in 1 POUCH (0924-1133-00)", "package_ndc": "0924-1133-00", "marketing_start_date": "20230508"}, {"sample": false, "description": "10 POUCH in 1 BOX (0924-1133-01)  / .9 g in 1 POUCH", "package_ndc": "0924-1133-01", "marketing_start_date": "20230508"}, {"sample": false, "description": "12 POUCH in 1 BOX (0924-1133-02)  / .9 g in 1 POUCH", "package_ndc": "0924-1133-02", "marketing_start_date": "20230508"}, {"sample": false, "description": "20 POUCH in 1 BOX (0924-1133-03)  / .9 g in 1 POUCH", "package_ndc": "0924-1133-03", "marketing_start_date": "20230508"}, {"sample": false, "description": "25 POUCH in 1 BOX (0924-1133-04)  / .9 g in 1 POUCH", "package_ndc": "0924-1133-04", "marketing_start_date": "20230508"}, {"sample": false, "description": "100 POUCH in 1 BOX (0924-1133-05)  / .9 g in 1 POUCH", "package_ndc": "0924-1133-05", "marketing_start_date": "20230508"}, {"sample": false, "description": "144 POUCH in 1 BOX (0924-1133-06)  / .9 g in 1 POUCH", "package_ndc": "0924-1133-06", "marketing_start_date": "20230508"}], "brand_name": "Hydrocortisone", "product_id": "0924-1133_26bc4721-ef08-2542-e063-6394a90a5642", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0924-1133", "generic_name": "Hydrocortisone", "labeler_name": "Acme United Corporation", "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": "20230508", "listing_expiration_date": "20261231"}