FDA.reportPublic FDA data

Hydrocortisone

Manufacturer
Medrock Pharmacy LLC | RT FORMULATORS LLC
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:21

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a physician Adults: 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 Children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch, Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips and offers temporary relief of minor skinirritations and inflammation due to 

  • Weather
  • Allergies
  • Cold sores
  • Eczema
  • Cosmetics

Other uses of this product should only be under the advice or supervision of a doctor.

Warnings:

WARNINGS SECTION

  • for external use only
  • Avoid contact with eyes  

Stop use and ask a physician:

OTC - STOP USE SECTION

  • if condition worsens or symptoms persist for 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a physician

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: consult a physician

For external anal itching:

SPL UNCLASSIFIED SECTION

  • Adults: 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

Children under 12 years of age: consult a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

• Ricinus Communis (Castor) Seed Oil • Beeswax • Helianthus Annuus (Sunflower) Seed Oil • Prunus Amygdalus Dulcis (Sweet Almond) Oil
• Theobroma Cacao (Cocoa) Seed Butter • Butyrospermum Parkii (Shea) Butter • Simmondsia Chinensis (Jojoba) Seed Oil
• Tocopheryl Acetate

Questions or Comments:

OTC - QUESTIONS SECTION

  • Call 1-833-633-7625
  • Email us: support@medrockpharmacy.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN2
106258hydrocortisone 10 MG/ML Topical CreamSCD2
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2
106258hydrocortisone 1 % Topical CreamSY2
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85402-001-01Hydrocortisone4.25 g in 1 TUBECREAM4.252
85402-001-01Hydrocortisone1 in 1 CARTONCREAM12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85402-00185402-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
BEESWAX2ZA36H0S2VIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEMedrock Pharmacy LLC43e00e17-1a48-43db-9589-834568917bbf2026-02-17WarningsExact identifier
ndc (package): 85402-001-01
ndc (product): 85402-001
ndc11 (package): 85402000101
spl id: 4b12aca8-f8aa-b413-e063-6294a90a0359
spl set id: 43e00e17-1a48-43db-9589-834568917bbf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.