FDA.reportPublic FDA data

HYDROCORTISONE

Manufacturer
CVS Pharmacy | Pharma Pac, LLC
Effective date
2011-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:28:55

Label at a glance#

ProductHYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                            Purpose

Hydrocortisone 1%.................................... Anti-itch cream


OTC - PURPOSE SECTION


Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor

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 immediately.

INDICATIONS & USAGE SECTION

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor

Other information

- store at room temperature. Protect from freezing and excessive heat.
- see carton or tube crimp for lot number and expiration date.

WARNINGS SECTION

Warnings

For external use only.

Do not use:
- in the eyes - for the treatment of diaper rash

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

- condition worsens, or if symptoms persist for more than 7 days

- symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION


Directions 


- adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily
- children under 2 years:do not use, ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa kernal flour oat, beeswax, cetyl alcohol, citric acid,
glyceryl stearate, isopropyl myristate, methylparaben, PEG-40 stearate, polysorbate 60,
propylene glycol, propylparaben, purified water, sodium citrate, sodium stearate, sorbic acid,
stearyl alcohol, tocopheryl acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

c
c


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM 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
59779-322-202019-10-29C16284748780-1960f7f55-d5d4-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-322-20HYDROCORTISONE28 g in 1 TUBECREAM281
59779-322-20HYDROCORTISONE1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-322HYDROCORTISONE CREAM [CVS PHARMACY]1Legacy NDC, 2 package rows20110726_7a02b713-df10-435d-acd5-3f9e6c2bea02.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGA1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
OATMEALINACTIVE INGREDIENT8PI54V663Y1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9I1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TG1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-32259779-322-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
POLYOXYL 40 STEARATE13A4J4NH9IIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
ANHYDROUS TRISODIUM CITRATERS7A450LGAIACT
SORBIC ACIDX045WJ989BIACT
SODIUM STEARATEQU7E2XA9TGIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
WHITE WAX7G1J5DA97FIACT
OATMEAL8PI54V663YIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROCORTISONEWI4X0X7BPJACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 453 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ICREAM / TOPICAL86000 mgExact identifier — unii candidate
13 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INTRAMUSCULAR101 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
61 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
19 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / VAGINAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
POLYOXYL 40 STEARATEPOLYOXYL 40 STEARATE TYPE I13A4J4NH9ISOLUTION / OPHTHALMIC7 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLOTION / TOPICAL211 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGASUSPENSION / ORAL21 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSUSPENSION / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL / TOPICAL0.08 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / RESPIRATORY (INHALATION)5 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TRANSDERMAL113 mgExact identifier — unii candidate
18 equally ranked IID candidates
ANHYDROUS TRISODIUM CITRATEANHYDROUS TRISODIUM CITRATERS7A450LGASOLUTION, CONCENTRATE / INTRAVENOUS24 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates

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
8eed5c4e-8e20-43f6-88b2-a04be7c50a6f7a02b713-df10-435d-acd5-3f9e6c2bea022011-02-16WarningsExact identifier
spl id: 8eed5c4e-8e20-43f6-88b2-a04be7c50a6f
spl set id: 7a02b713-df10-435d-acd5-3f9e6c2bea02

Reported adverse events (FAERS/openFDA)#

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