thera plus maximum strength hydrocortisone

Generic: hydrocortisone

Labeler: fourstar group usa, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name thera plus maximum strength hydrocortisone
Generic Name hydrocortisone
Labeler fourstar group usa, inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 10 mg/g

Manufacturer
Fourstar Group USA, Inc

Identifiers & Regulatory

Product NDC 80684-197
Product ID 80684-197_44fc2a10-d995-4d16-e063-6394a90a8c1f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-11-20

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 80684197
Hyphenated Format 80684-197

Supplemental Identifiers

RxCUI
106258
UPC
0049696123365
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 thera plus maximum strength 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
  • 6 PACKET in 1 BOX (80684-197-00) / .9 g in 1 PACKET
source: ndc

Packages (1)

80684-197-00 6 PACKET in 1 BOX (80684-197-00) / .9 g in 1 PACKET

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

Thera Plus Maximum Strength Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "44fc2a10-d995-4d16-e063-6394a90a8c1f", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0049696123365"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["7d4e21d1-2914-4690-9084-a52abeab0958"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Fourstar Group USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKET in 1 BOX (80684-197-00)  / .9 g in 1 PACKET", "package_ndc": "80684-197-00", "marketing_start_date": "20251120"}], "brand_name": "Thera Plus Maximum Strength Hydrocortisone", "product_id": "80684-197_44fc2a10-d995-4d16-e063-6394a90a8c1f", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80684-197", "generic_name": "HYDROCORTISONE", "labeler_name": "Fourstar Group USA, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera Plus Maximum Strength Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251120", "listing_expiration_date": "20261231"}