Proctosol-HC — Cream

Overview

Brand name

Proctosol-HC

Generic name

Hydrocortisone

Dosage form

Cream

Route

Topical

Marketing category

ANDA · ANDA

Labeler

Bryant Ranch Prepack

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Hydrocortisone	25 mg/g	604449	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Corticosteroid Hormone Receptor Agonists [MoA]	MoA	All 215 members
Corticosteroid [EPC]	EPC	All 215 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

088799

Application type

ANDA · Abbreviated New Drug Application

Approval date

November 9, 1984

Sponsor

TARO

Products on application

1

Submissions recorded

15

Products approved under application 088799.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
088799-001	HYDROCORTISONE	CREAM		HYDROCORTISONE	Prescription	AT

Therapeutic equivalence

Source: Orange Book

TE code

AT

Reference Listed Drug

No

Reference Standard

No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 088799.
Type	No.	Action	Status	Date	Review
Supplement	27	Labeling	Approved	July 28, 2005	—
Supplement	30	Labeling	Approved	April 28, 2005	—
Supplement	25	Labeling	Approved	April 29, 1993	—
Supplement	16	Labeling	Approved	November 16, 1992	—
Supplement	14	Labeling	Approved	February 21, 1992	—
Supplement	13	Labeling	Approved	December 17, 1990	—
Supplement	9	Manufacturing (CMC)	Approved	March 28, 1990	—
Supplement	6	Manufacturing (CMC)	Approved	March 28, 1990	—
Supplement	12	Manufacturing (CMC)	Approved	July 13, 1989	—
Supplement	11	Manufacturing (CMC)	Approved	July 13, 1989	—
Supplement	10	Labeling	Approved	May 5, 1989	—
Supplement	4	Manufacturing (CMC)	Approved	July 24, 1986	—
Supplement	2	Manufacturing (CMC)	Approved	December 6, 1985	—
Supplement	1	Manufacturing (CMC)	Approved	April 3, 1985	—
Original application	1		Approved	November 9, 1984	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251105). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20251105 HUMAN PRESCRIPTION DRUG · 20250702

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION Apply to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Description

openFDA Drug Labeling

DESCRIPTION Hydrocortisone is a synthetic steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11,17,21- trihydroxy-, (11β)- with empirical formula as C 21 H 30 O 5 and molecular weight 362.47. Its structural formula is: Proctosol-HC ® 2.5% (Hydrocortisone Cream USP, 2.5%) (Each gram contains 25 mg of Hydrocortisone) in a base containing cetyl alcohol, isopropyl palmitate, methylparaben, mineral oil and lanolin alcohol, polyoxyl 40 stearate, polysorbate 60, propylene glycol monostearate, propylene glycol, propylparaben, purified water, sorbic acid, and sorbitan monostearate. Chemical Structure

Overdosage

openFDA Drug Labeling

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS ).

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Proctosol-HC® 2.5% (Hydrocortisone Cream USP, 2.5%) in 1 oz (28.35 g) tubes NDC 72162-2165-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Adverse event reports

Source: openFDA FAERS

123,956

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: HYDROCORTISONE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
72162-2165-2	72162-2165	Bryant Ranch Prepack	1 TUBE in 1 CARTON (72162-2165-2) / 28.35 g in 1 TUBE	December 7, 2023
10631-407-01	10631-407	Sun Pharmaceutical Industries, Inc.	1 TUBE in 1 CARTON (10631-407-01) / 28.35 g in 1 TUBE	April 28, 2005
72162-2165	72162-2165	Bryant Ranch Prepack	—	April 28, 2005
10631-407	10631-407	Sun Pharmaceutical Industries, Inc.	—	April 28, 2005

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.