FDA.reportPublic FDA data

HYDROCORTISONE CREAM

Manufacturer
A-S Medication Solutions
Effective date
2019-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:26

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE ACETATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

OTC - PURPOSE SECTION

Purpose: anti-itch cream

WARNINGS SECTION

Warnings: For external use only. Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

OTC - DO NOT USE SECTION

Do not use:

  • in the eyes or over large portions of the body
  • for the treatment of diaper rash
  • with any other hydrocortisone product

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cetyl Alcohol, Citric Acid, Diazolidinyl Urea, Edetate Disodium, Glycerin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4456

NDC: 50090-4456-0 .9 g in a PACKET / 10 in a BOX, UNIT-DOSE

HYDROCORTISONE ACETATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN1
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD1
1043690hydrocortisone acetate 1 % Topical CreamSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4456-02023-01-30C16284748780-1f386c649-aa3a-0266-e053-dadaa90a7c1aHYDROCORTISONE CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4456-0HYDROCORTISONE10 in 1 BOX, UNIT-DOSECREAM101
50090-4456-0HYDROCORTISONE.9 g in 1 PACKETCREAM.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4456HYDROCORTISONE (HYDROCORTISONE ACETATE) CREAM [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20191228_a584d3ad-9a00-4acc-bf73-6a3cd509b053.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-445650090-4456-0
50332-0042

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONE ACETATE3X7931PO74ACTIB
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
ndc (product): 50332-0042
45bc24df-2f33-4055-b4d4-23bf9ef3f338a584d3ad-9a00-4acc-bf73-6a3cd509b0532019-10-14WarningsExact identifier
spl id: 45bc24df-2f33-4055-b4d4-23bf9ef3f338
spl set id: a584d3ad-9a00-4acc-bf73-6a3cd509b053

Reported adverse events (FAERS/openFDA)#

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