FDA.reportPublic FDA data

Hydrocortisone

Product NDC
63187-504
11-digit product format
631870504
Labeler code
63187
Product ID
63187-504_a3baeee4-2c76-4011-932b-c5b3ebd0a991
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
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
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
Hydrocortisone
Brand name suffix
with Aloe
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
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
0b26d92f-9d0e-46d4-a8bc-75d6da5f6199Available 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
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
63187-504-01Hydrocortisonewith Aloe28.4 g in 1 TUBECREAM28.45
63187-504-01Hydrocortisonewith Aloe1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-504HYDROCORTISONE WITH ALOE (HYDROCORTISONE) CREAM [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20240216_0b26d92f-9d0e-46d4-a8bc-75d6da5f6199.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 127 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEStratus Pharmaceuticals Ince1a8d4a7-01f7-4bab-8d09-875c461b3b612024-09-19WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Strategic Sourcing Services, LLC2216d799-7f6f-cab7-e063-6294a90a8d6c2024-09-14WarningsExact identifier
application number: M017
Meijer Analgesic Lidocaine Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Incf5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa2024-09-12WarningsExact identifier
application number: M017
leader anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECardinal Health 110, LLC. dba Leadere1aab35b-80d9-4515-afb7-8c662bc5d0282024-09-11WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.849c3601-2bc8-0991-e053-2a91aa0a5e7f2024-09-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - ArthritisMENTHOL 8%Telebrands Corpc22cf1a5-0d5d-5ea5-e053-2995a90a333b2024-09-02WarningsExact identifier
application number: M017
Itch and Rash CreamHYDROCORTISONEWildman Business Group1f95757d-a434-f02a-e063-6294a90a2d122024-09-01WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEWildman Business Group1fd1a4b3-b6fd-0d4c-e063-6394a90a36802024-09-01WarningsExact identifier
application number: M017
BIOSAVIA External Analgesic Pain ReliefCAPSAICINBIOSAVIA USA, LLC814aa66b-7719-4a29-a84e-18290367e9c72024-08-28WarningsExact identifier
application number: M017
Careland Plantar Fasciitis Hydrogel Pain PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.0e2f29c2-2e95-4be0-b7e9-f1761a1321a52024-08-21WarningsExact identifier
application number: M017
Careland Max Strength Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.265b8dd7-64a4-4bc2-a91c-26c761c2090b2024-08-21WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Topical AnalgesicMENTHOLREAL TIME PRODUCTS, INCf45eb95a-2813-4124-bdb0-54e078a8237d2024-08-20WarningsExact identifier
application number: M017
Theracare Lidocaine Pain reliefLIDOCAINEVeridian Healthcare1d8a3679-637d-94c0-e063-6294a90a9ecf2024-08-19WarningsExact identifier
application number: M017
LidoSyncLIDOCAINE, MENTHOLiON Pharma, LLC200f883c-439a-3b99-e063-6394a90aed102024-08-19WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited09243a23-1f17-f77b-e063-6394a90a0b222024-08-19WarningsExact identifier
application number: M017
CVS Health Maximum Strength Scalp Relief Anti-itchHYDROCORTISONECVS Healthb5ef0005-8b76-4205-8be0-db3a7ed7d1c42024-08-19WarningsExact identifier
application number: M017
Rite Aid Pain Relieving Roll-OnLIDOCAINE HCLRite Aid Corporation1406590c-667c-84eb-e063-6294a90a50522024-08-16WarningsExact identifier
application number: M017
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
application number: M017
FLANAXMETHYL SALICYLATE, MENTHOL, CAPSAICINBelmora LLC5e06c688-a086-4c1c-8dab-fcead61fef402024-08-13WarningsExact identifier
application number: M017
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN0b26d92f-9d0e-46d4-a8bc-75d6da5f61995
106258hydrocortisone 10 MG/ML Topical CreamSCD0b26d92f-9d0e-46d4-a8bc-75d6da5f61995
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY0b26d92f-9d0e-46d4-a8bc-75d6da5f61995
106258hydrocortisone 1 % Topical CreamSY0b26d92f-9d0e-46d4-a8bc-75d6da5f61995
106258hydrocortisone 1 GM per 100 GM Topical CreamSY0b26d92f-9d0e-46d4-a8bc-75d6da5f61995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-504-01631870504011 TUBE in 1 CARTON (63187-504-01) / 28.4 g in 1 TUBE1 tube2015-02-020000-00-00NoNoCurrent