hydrocortisone

Generic: hydrocortisone spray

Labeler: fsa store inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name hydrocortisone spray
Labeler fsa store inc.
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/mL

Manufacturer
FSA Store Inc.

Identifiers & Regulatory

Product NDC 81522-914
Product ID 81522-914_3ce24e45-ca33-d85d-e063-6294a90af326
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-08-19

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 81522914
Hyphenated Format 81522-914

Supplemental Identifiers

RxCUI
317564
UPC
0810025928971
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 spray (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 74 mL in 1 BOTTLE, SPRAY (81522-914-01)
source: ndc

Packages (1)

81522-914-01 74 mL in 1 BOTTLE, SPRAY (81522-914-01)

Ingredients (1)

hydrocortisone (10 mg/mL)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3ce24e45-ca33-d85d-e063-6294a90af326", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0810025928971"], "unii": ["WI4X0X7BPJ"], "rxcui": ["317564"], "spl_set_id": ["3ce24b87-55ac-0bbd-e063-6294a90ab582"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["FSA Store Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "74 mL in 1 BOTTLE, SPRAY (81522-914-01)", "package_ndc": "81522-914-01", "marketing_start_date": "20250819"}], "brand_name": "Hydrocortisone", "product_id": "81522-914_3ce24e45-ca33-d85d-e063-6294a90af326", "dosage_form": "SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "81522-914", "generic_name": "Hydrocortisone Spray", "labeler_name": "FSA Store Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250819", "listing_expiration_date": "20261231"}