FDA.reportPublic FDA data

Hydrocortisone

Manufacturer
Dr Marder Skincare LLC
Effective date
2019-11-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:23

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Wet hair thoroughly. apply shampoo, generously lather scalp for several minutes. Rinse thoroughly. repeat.Follow with Step 2 Dr. Marder Scalp Therapy total Relief Conditioner. Use Daily if needed.

WARNINGS SECTION

For external use only.

When using this product avoid contact with eyes.

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

INACTIVE INGREDIENT SECTION

HEXYLENE GLYCOL

POTASSIUM SORBATE

SODIUM C14-16 OLEFIN SULFONATE

WATER

ASCORBIC ACID

BIOTIN

CAFFEINE

CAMELLIA SINENSIS SEED OIL

CAPRYLYL GLYCOL

COCAMIDOPROPYL BETAINE

XANTHAN GUM

DECYL GLUCOSIDE

PANTHENOL

GLYCERIN

LAURYL GLUCOSIDE

LECITHIN, SOYBEAN

METHYLISOTHIAZOLINONE

PHENOXYETHANOL

PROPYLENE GLYCOL

RESVERATROL

VITAMIN A PALMITATE

SODIUM METABISULFITE

ALPHA-TOCOPHEROL ACETATE

GLYCOL STEARATE

COCONUT OIL

OTC - PURPOSE SECTION

Anti-Itch Liquid

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.

INDICATIONS & USAGE SECTION

Helps control the symptoms of scalp itch associated with minor skin irritations and rashes due to

  • Seborrheic Dermatitis
  • Eczema
  • Psoriasis

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1926571hydrocortisone 1 % Medicated ShampooPSN2
1926571hydrocortisone 10 MG/ML Medicated ShampooSCD2
1926571hydrocortisone 1 % Medicated ShampooSY2

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
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product 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
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct 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
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71516-001-012023-01-30C16284748780-1f386c649-cbe8-0266-e053-dadaa90a7c1aDr. Marder Scalp Therapy Total Relief Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71516-001-01Hydrocortisone180 mL in 1 BOTTLESHAMPOO1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71516-001HYDROCORTISONE SHAMPOO [DR MARDER SKINCARE LLC]2Legacy NDC, 1 package rows20191103_51dde4fa-88d7-19cd-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71516-00171516-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCOL STEARATE0324G66D0EIACT
HYDROCORTISONEWI4X0X7BPJACTIB
HEXYLENE GLYCOLKEH0A3F75JIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BIOTIN6SO6U10H04IACT
CAFFEINE3G6A5W338EIACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCONUT OILQ9L0O73W7LIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
RESVERATROLQ369O8926LIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SODIUM METABISULFITE4VON5FNS3CIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT

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
96613a74-42b4-0d23-e053-2995a90a577d51dde4fa-88d7-19cd-e054-00144ff88e882019-11-02WarningsExact identifier
spl id: 96613a74-42b4-0d23-e053-2995a90a577d
spl set id: 51dde4fa-88d7-19cd-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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