FDA.reportPublic FDA data

Signature Care Hydrocortisone

Product NDC
21130-395
11-digit product format
211300395
Labeler code
21130
Product ID
21130-395_354a0f3a-b56f-4b72-ba54-b128b7b64e70
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Safeway
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-24
Marketing end
2027-07-31
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
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
Signature Care Hydrocortisone

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
beefab66-b056-4bf1-b047-0780704ab87eAvailable 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
21130-395-16Signature Care Hydrocortisone1 in 1 CARTONCREAM16
21130-395-16Signature Care Hydrocortisone56 g in 1 TUBECREAM566
21130-395-64Signature Care Hydrocortisone1 in 1 CARTONCREAM16
21130-395-64Signature Care Hydrocortisone28 g in 1 TUBECREAM286

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
ISOSTEARYL NEOPENTANOATEINACTIVE INGREDIENT411THY156QSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1
WATERINACTIVE INGREDIENT059QF0KO0RSIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-395SIGNATURE CARE HYDROCORTISONE (HYDROCORTISONE) CREAM [SAFEWAY]6Current NDC, Legacy NDC, 4 package rows20241031_beefab66-b056-4bf1-b047-0780704ab87e.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 70 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAMPHOR, MENTHOL, AND MEHTYL SALICYLATEUnited Exchange Corporation78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc2025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNbeefab66-b056-4bf1-b047-0780704ab87e6
106258hydrocortisone 10 MG/ML Topical CreamSCDbeefab66-b056-4bf1-b047-0780704ab87e6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYbeefab66-b056-4bf1-b047-0780704ab87e6
106258hydrocortisone 1 % Topical CreamSYbeefab66-b056-4bf1-b047-0780704ab87e6
106258hydrocortisone 1 GM per 100 GM Topical CreamSYbeefab66-b056-4bf1-b047-0780704ab87e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-395-16211300395161 TUBE in 1 CARTON (21130-395-16) / 56 g in 1 TUBE1 tube2015-10-242027-07-31NoNoCurrent
21130-395-64211300395641 TUBE in 1 CARTON (21130-395-64) / 28 g in 1 TUBE1 tube2018-01-302027-06-30NoNoCurrent