FDA.reportPublic FDA data

equaline anti itch

Product NDC
41163-369
11-digit product format
411630369
Labeler code
41163
Product ID
41163-369_a237e46a-224c-4ced-acc6-c01f8f76cd72
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-25
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
equaline anti itch
Brand name suffix
maximum strength
Listing expiration
2027-12-31

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
070000d7-7d4d-439b-9a91-851ba7c027e6Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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
41163-369-64equaline anti itchmaximum strength1 in 1 CARTONCREAM18
41163-369-64equaline anti itchmaximum strength28 g in 1 TUBECREAM288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-369-64GM - Gram41163-369130da1f8-be3e-40ae-abfd-27e40a2c029012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3XEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WTEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
HYDROLYZED JOJOBA ESTERS (ACID FORM)INACTIVE INGREDIENTUDR641JW8WEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11PEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
OATINACTIVE INGREDIENTZ6J799EAJKEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
PPG-12/SMDI COPOLYMERINACTIVE INGREDIENT1BK9DDD24EEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
STEARAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTW6000VEI5YEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
STEARETH-2INACTIVE INGREDIENTV56DFE46J5EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
STEARETH-21INACTIVE INGREDIENT53J3F32P58EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCEQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SUPERVALU INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-369EQUALINE ANTI ITCH MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 2 package rows20241004_070000d7-7d4d-439b-9a91-851ba7c027e6.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 124 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
application number: M017
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
application number: M017
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
application number: M017
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
application number: M017
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact identifier
application number: M017
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
application number: M017
Fast Freeze LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.a96e3e41-871c-4cf3-93b6-af2a6246ded82024-10-04WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVS20234356-5e80-b79e-e063-6294a90a2ee32024-10-04WarningsExact identifier
application number: M017
FLANAX BACK PAIN RELIEFLIDOCAINEBelmora Llcaf4bf57c-f250-4506-83eb-e0f253e960622024-10-04WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC11a30ec9-ebc2-4a00-8a8d-431d0d973b372024-10-03WarningsExact identifier
application number: M017
pain relief patchLIDOCAINE 4%Bionpharma Inc.19c69983-4e78-8ec5-e063-6394a90a84be2024-10-03WarningsExact identifier
application number: M017
Good Sense Anti ItchHYDROCORTISONEL. Perrigo Companyecd6d841-40b9-42c9-825d-d172cd04824d2024-10-03WarningsExact identifier
application number: M017
Gold Bond Medicated Original Strength BodyMENTHOLNavajo Manufacturing Company Inc.f71d598c-92c3-d6fd-e053-6394a90a97d72024-10-03WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafeway9e663535-4acc-4b37-acae-8c17517c5a3d2024-10-03WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN070000d7-7d4d-439b-9a91-851ba7c027e68
106258hydrocortisone 10 MG/ML Topical CreamSCD070000d7-7d4d-439b-9a91-851ba7c027e68
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY070000d7-7d4d-439b-9a91-851ba7c027e68
106258hydrocortisone 1 % Topical CreamSY070000d7-7d4d-439b-9a91-851ba7c027e68
106258hydrocortisone 1 GM per 100 GM Topical CreamSY070000d7-7d4d-439b-9a91-851ba7c027e68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-369-64411630369641 TUBE in 1 CARTON (41163-369-64) / 28 g in 1 TUBE1 tube2011-02-250000-00-00NoNoCurrent