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 100 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Max Strength 1 Hydrocortisone CreamHYDROCORTISONEFamily Dollar Stores, Incbca5ac2c-45cd-44e3-98f1-317a04e44d7d2025-02-25WarningsExact identifier
application number: M017
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll OnMENTHOLADP Health Limited420d8cdc-f47f-4d33-bf25-9033ff266c492025-02-19WarningsExact identifier
application number: M017
AVCOO Pain ReliefMENTHOLADP Health Limited700ce2cf-749e-40be-91c3-850d9b2168ca2025-02-19WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLJell Pharmaceuticals Pvt. Ltd2e7c49de-5438-4858-e063-6294a90ad98c2025-02-19WarningsExact identifier
application number: M017
VTROUY Tattoo Numbing CreamTATTOO NUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2e899851-b3cd-0758-e063-6294a90afea82025-02-19WarningsExact identifier
application number: M017
Pomada Dragon Pain ReliefMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATEGenomma Lab USA9d98f48b-6d88-4df9-9459-7cf7ba5de0442025-02-19WarningsExact identifier
application number: M017
Pain Relieving CreamHISTAMINE DIHYDROCHLORIDEMediapower, Inc. DBA Dr Newton's And Naturals9eeea033-ae87-4d83-85d0-b8fa653a08062025-02-19WarningsExact identifier
application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, RegularALUMINUM CHLOROHYDRATESodalis USA, LLC7839cf53-dbd2-4dbb-a309-1581d51f8adc2025-02-18WarningsExact identifier
application number: M017
CANNA NUMB Roll OnLIDOCAINE HYDROCHLORIDE, MENTHOLCannanumb LLCc1eb0348-3b0e-4f1c-a46b-1ff4aa165fb42025-02-17WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz.CAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.7173b141-123e-6cd4-e053-2a95a90a86002025-02-12WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz. 3 pkCAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.71c186a1-8283-2482-e053-2995a90acc1f2025-02-12WarningsExact identifier
application number: M017
Roman SwipesBENZOCAINERoman Health Ventures Inc.7f0eac8c-7235-99d8-e053-2a91aa0a634e2025-02-12WarningsExact identifier
application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOREVI LABSEVI LABS2df7658d-83d3-41ac-e063-6294a90ab1dd2025-02-12WarningsExact identifier
application number: M017
Signature Care Medicated Pain Relief PatchLIDOCAINESafeway, Inc.2165a342-5f8b-78e0-e063-6394a90a06c42025-02-12WarningsExact identifier
application number: M017
CheeZheng Pain Relieveing PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd.abcebdf1-9037-4094-93e1-ce8f20b18ea72025-02-11WarningsExact identifier
application number: M017
Tibetree Pain Relieveing Medicated PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd4216bd48-5c62-4e87-adcc-67bf7152d64d2025-02-11WarningsExact identifier
application number: M017
AsperFlexLIDOCAINEAkron Pharma Inc.ab50525e-b534-452b-8c25-2992c0cbf8622025-02-10WarningsExact 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