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

Additional Listing Data#

Finished product
Yes
Brand name base
Signature Care Hydrocortisone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258

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

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