thera plus anti-itch with aloe 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 anti-itch with aloe 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 80684-038
Product ID 80684-038_08a0f5fb-bc99-45d2-e063-6294a90a623c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-01-30

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 80684038
Hyphenated Format 80684-038

Supplemental Identifiers

RxCUI
106258
UPC
0049696865906
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 anti-itch with aloe 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
  • 1 TUBE in 1 BOX (80684-038-01) / 28 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (1)

hydrocortisone (10 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "08a0f5fb-bc99-45d2-e063-6294a90a623c", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0049696865906"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["c69d0670-a65b-1680-e053-2995a90a2ee5"], "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": "1 TUBE in 1 BOX (80684-038-01)  / 28 g in 1 TUBE", "package_ndc": "80684-038-01", "marketing_start_date": "20220130"}], "brand_name": "Thera plus Anti-itch with aloe Hydrocortisone", "product_id": "80684-038_08a0f5fb-bc99-45d2-e063-6294a90a623c", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80684-038", "generic_name": "HYDROCORTISONE", "labeler_name": "Fourstar Group USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera plus Anti-itch with aloe Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220130", "listing_expiration_date": "20261231"}