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Alacort

Hydrocortisone · Cream

Prescription ANDA TE AT Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Alacort
Generic name
Hydrocortisone
Dosage form
Cream
Route
Topical
Marketing category
ANDA · ANDA
Labeler
Crown Laboratories
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
5
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 10 mg/g 604449 View
Hydrocortisone 25 mg/g 604449 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Topical
Presentations
7

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@FDANDC Directory
Application number
080706
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 9, 1973
Sponsor
CROWN LABS
Products on application
2
Submissions recorded
7
Products approved under application 080706.
Product Trade name Form Strength Ingredient Status TE Flags
080706-006 ALA-CORT CREAM HYDROCORTISONE Prescription AT
080706-007 ALA-CORT 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 080706.
Type No. Action Status Date Review
Supplement 12 Labeling Approved September 22, 2015 Standard
Supplement 8 Labeling Approved January 28, 1997 —
Supplement 7 Labeling Approved May 22, 1992 —
Supplement 6 Manufacturing (CMC) Approved July 10, 1985 —
Supplement 5 Manufacturing (CMC) Approved July 10, 1985 —
Supplement 2 Manufacturing (CMC) Approved May 12, 1982 —
Original application 1 Approved March 9, 1973 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260112). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260112

Indications and Usage

openFDA Drug Labeling

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

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION Topical corticosteroids are generally applied 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, foliculitiis, 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 The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11β)-. Its molecular formula is C 21 H 30 O 5 and molecular weight is 362.47. Its structural formula is: Each gram of ALA-CORT ® (Hydrocortisone Cream USP) 1% contains 10 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. Each gram of ALA-CORT® (Hydrocortisone Cream USP) 2.5% contains 25 mg hydrocortisone USP in a cream base consisting of purified water, cetyl alcohol, glycerin, stearyl alcohol, propylene glycol, sodium lauryl sulfate, cetyl palmitate and sorbic acid. hc structure

Overdosage

openFDA Drug Labeling

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

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED ALA-CORT ® (Hydrocortisone Cream USP), 1% is supplied in: 1 ounce (28.4 grams) tube NDC 0316-0126-01 3 ounce (85.2 grams) tube NDC 0316-0126-03 ALA-CORT® (Hydrocortisone Cream USP), 2.5% is supplied in: 20 grams tube NDC 0316-0128-20 30 grams tube NDC 0316-0128-30 454 grams jar NDC 0316-0128-16 Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604 PRINTED IN USA ​Revised: OCT 2015 P8000.03

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
0316-0126-01 0316-0126 Crown Laboratories 1 TUBE in 1 CARTON (0316-0126-01) / 28.4 g in 1 TUBE March 9, 1973
0316-0126-03 0316-0126 Crown Laboratories 1 TUBE in 1 CARTON (0316-0126-03) / 85.2 g in 1 TUBE March 9, 1973
0316-0128-16 0316-0128 Crown Laboratories 454 g in 1 JAR (0316-0128-16) January 6, 2016
0316-0128-20 0316-0128 Crown Laboratories 1 TUBE in 1 CARTON (0316-0128-20) / 20 g in 1 TUBE January 6, 2016
0316-0128-30 0316-0128 Crown Laboratories 1 TUBE in 1 CARTON (0316-0128-30) / 30 g in 1 TUBE January 6, 2016
0316-0126 0316-0126 Crown Laboratories — March 9, 1973
0316-0128 0316-0128 Crown Laboratories — January 6, 2016

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.