FDA.reportPublic FDA data

Cortizone 10 Intensive Healing for Eczema

Product NDC
41167-0331
Requested package NDC
41167-0331-0
11-digit product format
411670331
Labeler code
41167
Product ID
41167-0331_d4774d0b-59ad-4ca7-9af8-3754e3dbe6bd
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
LOTION
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-12-08
Substance
HYDROCORTISONE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cortizone 10 Intensive Healing for Eczema
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103403Internal RxNorm lookup
1039279Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31dc0f1f-ddd8-41dc-b669-b24655634d55Available on FDA.report

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
41167-0331-0Cortizone 10 Intensive Healing for Eczema99 g in 1 TUBELOTION995
41167-0331-0Cortizone 10 Intensive Healing for Eczema1 in 1 CARTONLOTION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0331CORTIZONE 10 INTENSIVE HEALING FOR ECZEMA (HYDROCORTISONE) LOTION [CHATTEM, INC.]4Current NDC, Legacy NDC, 2 package rows20231207_31dc0f1f-ddd8-41dc-b669-b24655634d55.zip

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 68 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aulief Topical Pain RelieverMENTHOL AND CAMOHORChina-Gel, LLC8647dcc3-1dbc-1093-e053-2991aa0a1ab92025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLC254abae9-ef1b-5a90-e054-00144ff88e882025-11-04WarningsExact identifier
application number: M017
Pain Relief Gel-TubeMENTHOLBullet point LLC42c93789-9758-54b7-e063-6394a90ac3982025-11-04WarningsExact identifier
application number: M017
Tattoo careTATTOO CARE CREAMPerfso (HK) Co., Limited42d0f56f-9cb1-8e19-e063-6394a90aa3e02025-11-04WarningsExact identifier
application number: M017
CORE RELIEFCAMPHOR, MENTHOLCopper Joint, LLC42d17270-f58d-9d69-e063-6294a90a40782025-11-04WarningsExact identifier
application number: M017
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINE 5%YYBA Corp1319ee69-8b3f-5815-e063-6294a90a5ad52025-11-03WarningsExact identifier
application number: M017
Goodsense Extra Strength Cold and Hot MedicatedMENTHOLGeiss, Destin and Dunn, Inc.7585d111-775f-4fb6-a485-28cd99d888522025-10-31WarningsExact identifier
application number: M017
Topcare Cold and Hot MedicatedMENTHOLTopco Associates LLC8739aedd-165c-5ae0-e053-2a91aa0afcd02025-10-31WarningsExact identifier
application number: M017
CVS Medicated Heat 1 ctCAPSAICINCVS Pharmacy, Inc.d41dce5b-e698-4930-8869-040b2a973f252025-10-31WarningsExact identifier
application number: M017
Coralite Medicated HeatCAPSAICINUnited Exchange Corp.a0b89c7e-80bc-43c4-840c-5fd567f60b212025-10-31WarningsExact identifier
application number: M017
Dragon with Arnical Pain ReliefMENTHOLGenomma Lab USA Inc.b4cbb7b6-cb71-9721-e053-2995a90a2b2c2025-10-31WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY SOLID Ointment.GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT.Guangdong Quadrant Ecological Technology Co., Ltd.425b1b9d-c33a-05e9-e063-6394a90a97a62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY Spray.GEMACHLICH ZUHAUSE NEUROPATHY SPRAY.Guangdong Quadrant Ecological Technology Co., Ltd.425b8259-af38-8d68-e063-6394a90a11202025-10-30WarningsExact identifier
application number: M017
Family Care Muscle and JointMENTHOLUnited Exchange Corp.959af9f4-7188-91a1-e053-2995a90a46652025-10-30WarningsExact identifier
application number: M017
CVS Maximum Strength Boil ReliefBENZOCAINECVS Pharmacy, Inc.0761b866-af34-42bd-adc9-3d229170d01c2025-10-30WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44ca52d-fec8-0e8c-e053-2995a90a2e602025-10-30WarningsExact identifier
application number: M017
CVS CAPSAICINCAPSAICINCVS PHARMACY9b551fe3-3842-482a-9042-63de5ad398842025-10-30WarningsExact identifier
application number: M017
TopCare Health Pain ReliefMENTHOL, CAMPHOR, AND METHYL SALICYLATETopco Associates LLCdac364ef-6dcd-3fc6-e053-2a95a90a9bb22025-10-30WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039279Cortizone-10 1 % Topical LotionPSN31dc0f1f-ddd8-41dc-b669-b24655634d555
103403hydrocortisone 1 % Topical LotionPSN31dc0f1f-ddd8-41dc-b669-b24655634d555
1039279hydrocortisone 10 MG/ML Topical Lotion [Cortizone]SBD31dc0f1f-ddd8-41dc-b669-b24655634d555
103403hydrocortisone 10 MG/ML Topical LotionSCD31dc0f1f-ddd8-41dc-b669-b24655634d555
1039279Cortizone 1 % Topical LotionSY31dc0f1f-ddd8-41dc-b669-b24655634d555
1039279Cortizone 10 MG/ML Topical LotionSY31dc0f1f-ddd8-41dc-b669-b24655634d555
103403hydrocortisone 1 % Topical LotionSY31dc0f1f-ddd8-41dc-b669-b24655634d555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0331-0411670331001 TUBE in 1 CARTON (41167-0331-0) / 99 g in 1 TUBE1 tube2009-12-080000-00-00NoNoCurrent