FDA.reportPublic FDA data

CVS

Product NDC
59779-099
11-digit product format
597790099
Labeler code
59779
Product ID
59779-099_39944197-d294-1a96-e063-6294a90aa898
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-08-23
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
CVS
Brand name suffix
Cortisone
Listing expiration
2026-12-31

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
106258Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87631be8-94b8-4718-858d-d2f30e636cceAvailable 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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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
59779-099-02CVSCortisone30 g in 1 TUBECREAM305
59779-099-02CVSCortisone1 in 1 CARTONCREAM15
59779-099-03CVSCortisone1 in 1 CARTONCREAM15
59779-099-03CVSCortisone60 g in 1 TUBECREAM605
59779-099-04CVSCortisone60 g in 1 TUBECREAM605
59779-099-04CVSCortisone2 in 1 CARTONCREAM25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-099-02GM - Gram59779-099408df831-6717-4509-9568-4a2dfc6f361812018-01-12
59779-099-03GM - Gram59779-099fd89f994-1b20-4a98-9eef-010c8655541a12017-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0CVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
chamomile flower oilINACTIVE INGREDIENT60F80Z61A9CVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
cholecalciferolINACTIVE INGREDIENT1C6V77QF41CVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
corn oilINACTIVE INGREDIENT8470G57WFMCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZECVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVCCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1
waterINACTIVE INGREDIENT059QF0KO0RCVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-099CVS CORTISONE (HYDROCORTISONE) CREAM [CVS PHARMACY]4Current NDC, Legacy NDC, 6 package rows20241116_87631be8-94b8-4718-858d-d2f30e636cce.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 141 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Anti-itchHYDROCORTISONERite Aid0c540422-1579-9217-e063-6294a90ad06a2023-12-12WarningsExact identifier
application number: M017
Anti-itch Paraben FreeHYDROCORTISONEWeeks & Leo Co., Inc.0c5419c5-0929-7ca6-e063-6294a90ac0a72023-12-12WarningsExact identifier
application number: M017
Rite Aid HydrocortisoneHYDROCORTISONE 1%Rite Aid0c580f96-7fe9-19df-e063-6394a90a5a222023-12-12WarningsExact identifier
application number: M017
Anti itchHYDROCORTISONEWeeks & Leo Co., Inc.0c58b750-d3a6-5ed1-e063-6294a90a43212023-12-12WarningsExact identifier
application number: M017
Greencaine BlastLIDOCAINEALMA Laboratories, Inc.031e0065-4c8a-43d8-bc69-3efa3c6c0ae32023-12-12WarningsExact identifier
application number: M017
Ageless Pain ReliefMETHYL SALICYLATE, MENTHOLIsagenix International, LLC3c7e493b-923d-44b1-9076-46c7894308d42023-12-12Warnings, Adverse reactionsExact identifier
application number: M017
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
application number: M017
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
application number: M017
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact identifier
application number: M017
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
application number: M017
Katinko External Analgesic OilCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.5881fc35-3293-4f0b-801a-afcd6feb94962023-12-08WarningsExact identifier
application number: M017
Katinko Pain And Itch RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.fe907fa4-4a01-4974-b71f-9cd980b4eaa22023-12-08Warnings, Adverse reactionsExact identifier
application number: M017
CycleMENTHOLLa Mend, Inc.cfc0bcde-ef91-1e6c-e053-2a95a90ab79e2023-12-07WarningsExact identifier
application number: M017
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017
ProlayedLIDOCAINEMATRIX MIXOLOGY, INCae317876-adb1-6d13-e053-2995a90a74af2023-12-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN87631be8-94b8-4718-858d-d2f30e636cce5
106258hydrocortisone 10 MG/ML Topical CreamSCD87631be8-94b8-4718-858d-d2f30e636cce5
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY87631be8-94b8-4718-858d-d2f30e636cce5
106258hydrocortisone 1 % Topical CreamSY87631be8-94b8-4718-858d-d2f30e636cce5
106258hydrocortisone 1 GM per 100 GM Topical CreamSY87631be8-94b8-4718-858d-d2f30e636cce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-099-02597790099021 TUBE in 1 CARTON (59779-099-02) / 30 g in 1 TUBE1 tube2012-12-280000-00-00NoNoCurrent
59779-099-03597790099031 TUBE in 1 CARTON (59779-099-03) / 60 g in 1 TUBE1 tube2012-12-280000-00-00NoNoCurrent
59779-099-04597790099042 TUBE in 1 CARTON (59779-099-04) / 60 g in 1 TUBE2 tube2019-11-150000-00-00NoNoCurrent