FDA.reportPublic FDA data

cortisone

Product NDC
59779-878
11-digit product format
597790878
Labeler code
59779
Product ID
59779-878_36f9e1d5-02cc-4b78-88e1-5b4ac01d9f8c
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-10
Substance
HYDROCORTISONE
Active strength
1 g/100g
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
cortisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c766deac-d993-4e48-a5c3-4cfde7338dffAvailable 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
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
9bfd9c37-f773-6e9a-5f6b-6f5701d62adcProduct 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
59779-878-25cortisone99 g in 1 TUBELOTION994
59779-878-25cortisone1 in 1 CARTONLOTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-878-25GM - Gram59779-878f204c482-6936-4a71-9c95-bfa83f1005f212017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40CORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
GINGERINACTIVE INGREDIENTC5529G5JPQCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
ICODEXTRININACTIVE INGREDIENT2NX48Z0A9GCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ECORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5CORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11PCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
OATINACTIVE INGREDIENTZ6J799EAJKCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RCORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-878CORTISONE (HYDROCORTISONE) LOTION [CVS PHARMACY]4Current NDC, Legacy NDC, 2 package rows20241102_c766deac-d993-4e48-a5c3-4cfde7338dff.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 112 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b6c3d6eb-b485-33b8-e053-2a95a90a41e12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.b4cd4fed-e8c8-db85-e053-2995a90a708b2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain Relief LiquidMENTHOL 16%Tommie Copper, Inc.c93a0139-953b-5523-e053-2a95a90a0b2d2024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.ca011b03-a263-1908-e053-2995a90ad9702024-12-15WarningsExact identifier
application number: M017
Warrior Chiggerex ReliefBENZOCAINE 10%Derma Care Research Labs, LLCdcf2f52b-2295-58e5-e053-2995a90a7fd82024-12-15WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLCdef8d341-06a7-0e9b-e053-2995a90a0ad62024-12-13WarningsExact identifier
application number: M017
Mentholatum OriginalCAMPHOR, MENTHOLThe Mentholatum Company19e4b812-67c6-49fd-833a-b432100363f52024-12-13WarningsExact identifier
application number: M017
Cold and Hot MedicatedMENTHOLThe Mentholatum Company85bf425d-59d7-4462-ba46-2921454600992024-12-13WarningsExact identifier
application number: M017
Mentholatum Lidocaine IceLIDOCAINE HCL, MENTHOLThe Mentholatum Company4d74cbab-31cd-4579-9360-6852ee215b5e2024-12-13WarningsExact identifier
application number: M017
Mentholatum Deep Heating Rub Extra StrengthMENTHOL, METHYL SALICYLATEThe Mentholatum Companyf5684158-0d83-4031-b493-5422ddc73e782024-12-13WarningsExact identifier
application number: M017
Discount Drug Mart Anti-ItchCAMPHOR, MENTHOLDiscount Drug Mart87d379da-103a-c751-e053-2995a90a56de2024-12-13WarningsExact identifier
application number: M017
Audiologist Anti-itchHYDROCORTISONEOAKTREE PRODUCTS, INC.853e078e-1e91-d55f-e053-2991aa0a6dcd2024-12-13WarningsExact identifier
application number: M017
CVS Anti itchHYDROCORTISONECVS884df604-711b-4a3d-e053-2995a90a3a042024-12-13WarningsExact identifier
application number: M017
Dermoplast Pain RelievingBENZOCAINE AND LEVOMENTHOLAdvantice Health, LLC2347f0b8-d463-422d-8583-65624d9a1a912024-12-12WarningsExact identifier
application number: M017
HealthWise Medicated Foot PowderMENTHOLVeridian Healthcare2916a0c3-2d66-d079-e063-6394a90acd6b2024-12-12WarningsExact identifier
application number: M017
Ease Your PainMENTHOLProximity Capital Partners LLC dba Asutra83366ae1-e1d9-2a30-e053-2a91aa0a1cc42024-12-12WarningsExact identifier
application number: M017
Natural Seal Itch Relief for KidsLIDOCAINEKericure Inc.31cc0c95-5864-4737-b085-8f58e00f4f052024-12-12WarningsExact identifier
application number: M017
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHYDROCORTISONE ACETATECombe Incorporated9b69fa24-02dd-43e4-a81f-9a37968d70992024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Medicated Creme Maximum StrengthBENZOCAINE AND RESORCINOLCombe Incorporatedbb73ebd7-ceb0-4b54-9e8f-77486d9037fb2024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Creme Regular StrengthBENZOCAINE AND RESORCINOLCombe Incorporateddd303ff8-0deb-4292-bfd8-5bda91f86d512024-12-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103403hydrocortisone 1 % Topical LotionPSNc766deac-d993-4e48-a5c3-4cfde7338dff4
103403hydrocortisone 10 MG/ML Topical LotionSCDc766deac-d993-4e48-a5c3-4cfde7338dff4
103403hydrocortisone 1 % Topical LotionSYc766deac-d993-4e48-a5c3-4cfde7338dff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-878-25597790878251 TUBE in 1 CARTON (59779-878-25) / 99 g in 1 TUBE1 tube2012-04-100000-00-00NoNoCurrent