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sunmark

Hydrocortisone · Ointment

Over-the-counter M 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
sunmark Hydrocortisone
Generic name
Hydrocortisone
Dosage form
Ointment
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
Strategic Sourcing Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
7
NDC product codes
3
Packages
3
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
Bacitracin Zinc 500 [USP'U]/g 204602 View
Bacitracin Zinc 500 [iU]/g 204602 View
Hydrocortisone 1 g/100g 604449 View
Neomycin Sulfate 3.5 mg/g 204602 View
Polymyxin B Sulfate 10000 [USP'U]/g 204602 View
Polymyxin B Sulfate 10000 [iU]/g 204602 View
Pramoxine Hydrochloride 10 mg/g 1234532 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Topical
Presentations
6

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
Aminoglycoside Antibacterial [EPC] EPC All 66 members
Aminoglycosides [CS] CS All 66 members
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members
Decreased Cell Wall Synthesis & Repair [PE] PE All 41 members
Polymyxin-class Antibacterial [EPC] EPC All 55 members
Polymyxins [CS] CS All 55 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
000004
Application type
M
Approval date
July 16, 1969
Sponsor
PHARMICS
Products on application
1
Submissions recorded
3
Products approved under application 000004.
Product Trade name Form Strength Ingredient Status TE Flags
000004-004 PAREDRINE SOLUTION/DROPS HYDROXYAMPHETAMINE HYDROBROMIDE Discontinued —

Approval history

Source: Drugs@FDA
Most recent submissions on application 000004.
Type No. Action Status Date Review
Supplement 11 Labeling Approved May 26, 1987 —
Supplement 10 Labeling Approved May 8, 1980 —
Original application 1 Approved July 16, 1969 Unknown

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250715). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250715 HUMAN OTC DRUG · 20250707

Indications and Usage

openFDA Drug Labeling

Uses for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry external genital and anal itching other uses of this product should be only under the advice and supervision of a doctor.

Purpose

openFDA Drug Labeling

Active ingredients (in each gram) Purposes Bacitracin 500 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B 10,000 units First aid antibiotic Pramoxine HCl 10 mg Topical pain reliever

Dosage and Administration

openFDA Drug Labeling

Directions when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily children under 12 years of age: Do not use, consult a doctor

Warnings

openFDA Drug Labeling

Warnings for external use only avoid contact with the eyes do not put this product into the rectum by using fingers or any mechanical device or applicator Stop using this product and ask a doctor in case of bleeding if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product Do not use this product and ask a doctor if you have a vaginal discharge before treating diaper rash before using on children under 2 years of age For External Anal Itching Users do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly do not put this product into the rectum by using fingers or any mechanical device or applicator children under 12 years of age: consult a doctor Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Before using any medication, read all label directions. Keep this carton. It contains important information.

Do Not Use

openFDA Drug Labeling

Do not use this product and ask a doctor if you have a vaginal discharge before treating diaper rash before using on children under 2 years of age

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have deep or puncture wounds animal bites serious burns

Stop Use

openFDA Drug Labeling

Stop using this product and ask a doctor in case of bleeding if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each gram) Purposes Bacitracin 500 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B 10,000 units First aid antibiotic Pramoxine HCl 10 mg Topical pain reliever

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
49348-274-72 49348-274 Strategic Sourcing Services LLC 1 TUBE in 1 CARTON (49348-274-72) / 28.4 g in 1 TUBE December 5, 1990
49348-522-72 49348-522 Strategic Sourcing Services LLC 1 TUBE in 1 CARTON (49348-522-72) / 28.4 g in 1 TUBE February 13, 2013
49348-600-72 49348-600 Strategic Sourcing Services LLC 1 TUBE in 1 CARTON (49348-600-72) / 28.4 g in 1 TUBE February 13, 2013
49348-274 49348-274 Strategic Sourcing Services LLC — December 5, 1990
49348-522 49348-522 Strategic Sourcing Services LLC — October 3, 1989
49348-600 49348-600 Strategic Sourcing Services LLC — March 31, 2012

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
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.