FDA.reportPublic FDA data

rexall anti itch

Product NDC
55910-225
11-digit product format
559100225
Labeler code
55910
Product ID
55910-225_81484ab5-e657-4297-ad8d-00f24c3ec0e8
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Dolgencorp, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-08-31
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
rexall anti itch
Brand name suffix
maximum strength relief
Listing expiration
2026-12-31

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
55910-225-64rexall anti itchmaximum strength relief28 g in 1 TUBECREAM287
55910-225-64rexall anti itchmaximum strength relief1 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
HYDROLYZED JOJOBA ESTERS (ACID FORM)INACTIVE INGREDIENTUDR641JW8WREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11PREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
OATINACTIVE INGREDIENTZ6J799EAJKREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
STEARETH-21INACTIVE INGREDIENT53J3F32P58REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RREXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-225REXALL ANTI ITCH MAXIMUM STRENGTH RELIEF (HYDROCORTISONE) CREAM [DOLGENCORP, LLC]7Current NDC, Legacy NDC, 2 package rows20241004_894cf9ab-693a-4210-96df-605947f51b63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN894cf9ab-693a-4210-96df-605947f51b637
106258hydrocortisone 10 MG/ML Topical CreamSCD894cf9ab-693a-4210-96df-605947f51b637
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY894cf9ab-693a-4210-96df-605947f51b637
106258hydrocortisone 1 % Topical CreamSY894cf9ab-693a-4210-96df-605947f51b637
106258hydrocortisone 1 GM per 100 GM Topical CreamSY894cf9ab-693a-4210-96df-605947f51b637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-225-64559100225641 TUBE in 1 CARTON (55910-225-64) / 28 g in 1 TUBE1 tube2010-08-310000-00-00NoNoCurrent