FDA.reportPublic FDA data

Dr. Sheffield Hydrocortisone Anti itch

Product NDC
11527-052
11-digit product format
115270052
Labeler code
11527
Product ID
11527-052_73503439-5ce2-480b-bf3f-9362a31c8e29
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-07-10
Substance
HYDROCORTISONE
Active strength
10 mg/g
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
Dr. Sheffield Hydrocortisone Anti itch
Listing expiration
2026-12-31

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 · 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
71c9f2f4-2188-45eb-b55e-3856ac78070bAvailable 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
11527-052-51Dr. Sheffield Hydrocortisone Anti itch1 in 1 CARTONCREAM14
11527-052-51Dr. Sheffield Hydrocortisone Anti itch14 g in 1 TUBECREAM144
11527-052-55Dr. Sheffield Hydrocortisone Anti itch1 in 1 CARTONCREAM14
11527-052-55Dr. Sheffield Hydrocortisone Anti itch28 g in 1 TUBECREAM284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
ISOSTEARYL NEOPENTANOATEINACTIVE INGREDIENT411THY156QDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7DR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RDR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-052DR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [SHEFFIELD PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20231031_71c9f2f4-2188-45eb-b55e-3856ac78070b.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 98 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
application number: M017
Herb AnalgesicHERB ANALGESIC PASTEChangsha Maocheng Trading Co., Ltd29373587-9eff-6ea0-e063-6394a90a23b22025-03-18WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
application number: M017
Auvon 4% Menthol Pain Relief GelMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.2dacd6fe-7d69-bcf0-e063-6294a90a03512025-03-14WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limited1ee49cad-84d4-42cf-aa83-c0da6f1b1b842025-03-14WarningsExact identifier
application number: M017
AY BENDITO THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
application number: M017
Hot/Cold Medicated PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Marcella Health3054e7fd-cab2-7f77-e063-6294a90a498d2025-03-14WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Marcella Health30914c0a-fbda-5674-e063-6294a90aba5b2025-03-14WarningsExact identifier
application number: M017
Peppermint Soothing PatchCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORMHenan Lijitang Medical Technology Co., Ltd.30361dd4-1f3d-ac5e-e063-6294a90a23bc2025-03-13WarningsExact identifier
application number: M017
AVCOO Menthol Pain Relief PatchMENTHOLADP Health Limited3036804b-16c3-0c88-e063-6394a90a30842025-03-13WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Marcella Health303d9462-cbfb-6251-e063-6394a90a70652025-03-13WarningsExact identifier
application number: M017
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsExact identifier
application number: M017
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
application number: M017
TheraCare Pain Relief 4% LidocaineLIDOCAINEVeridian Healthcare2d3fc030-5d53-2acd-e063-6294a90a11ab2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d04799f-946d-ac53-e063-6294a90afeb72025-03-11WarningsExact identifier
application number: M017
Muscle and Joint CareLIDOCAINEVege Labs LLC.301966b5-b535-dc04-e063-6394a90aec172025-03-11WarningsExact identifier
application number: M017
Arctic Blast Pain ReleivingMENTHOL, CAMPHOR (SYNTHETIC)Nutriomo Labs Pte, Ltdd5e7d26d-4f63-4b7b-a173-fe3a794c84592025-03-10WarningsExact identifier
application number: M017
Anti ItchWALGREENWalgreens30014ff0-2519-4031-e063-6394a90ae07b2025-03-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN71c9f2f4-2188-45eb-b55e-3856ac78070b4
106258hydrocortisone 10 MG/ML Topical CreamSCD71c9f2f4-2188-45eb-b55e-3856ac78070b4
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY71c9f2f4-2188-45eb-b55e-3856ac78070b4
106258hydrocortisone 1 % Topical CreamSY71c9f2f4-2188-45eb-b55e-3856ac78070b4
106258hydrocortisone 1 GM per 100 GM Topical CreamSY71c9f2f4-2188-45eb-b55e-3856ac78070b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-052-51115270052511 TUBE in 1 CARTON (11527-052-51) / 14 g in 1 TUBE1 tube2007-07-100000-00-00NoNoCurrent
11527-052-55115270052551 TUBE in 1 CARTON (11527-052-55) / 28 g in 1 TUBE1 tube2007-07-100000-00-00NoNoCurrent