FDA.reportPublic FDA data

Anti-itch

Product NDC
53329-091
11-digit product format
533290091
Labeler code
53329
Product ID
53329-091_40c054e1-8661-4940-e063-6294a90a0200
Type
HUMAN OTC DRUG
Nonproprietary name
hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-01
Substance
HYDROCORTISONE
Active strength
10 mg/g
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
Anti-itch
Listing expiration
2027-12-31

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
b0947381-c0db-4253-ab40-3d45603ae65dAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-091-012023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-012023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-902023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-902023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-912023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-912023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-962023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-962023-08-08091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-012023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-012023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-902023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-902023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-912023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-912023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-962023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-962023-07-28091 Curad Hydrocortisone 1% Cream Anti-itch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-091-01Anti-itch28.4 g in 1 TUBECREAM28.413
53329-091-01Anti-itch1 in 1 BOXCREAM113
53329-091-90Anti-itch1.5 g in 1 PACKETCREAM1.513
53329-091-91Anti-itch48 in 1 CARTONCREAM4813
53329-091-96Anti-itch144 in 1 CASECREAM14413
53329-091-96Anti-itch28.4 g in 1 TUBECREAM28.413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-091-01GM - Gram53329-0919ab0f641-eef6-4977-a15b-abc165bf39b712018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A065ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-091ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, LP]13Current NDC, Legacy NDC, 6 package rows20250112_b0947381-c0db-4253-ab40-3d45603ae65d.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 57 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC457c9bd6-2e72-03e5-e063-6394a90a558c2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMP ROLL-ONCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC3e552afc-9305-8825-e063-6294a90a1afe2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC457d89aa-4a84-94a6-e063-6294a90a20c02025-12-08WarningsExact identifier
application number: M017
Gold Bond Medicated Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLGold Bond Co LLC4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b2025-12-05WarningsExact identifier
application number: M017
Orajel for Cold Sores Double Medicated, CreamBENZOCAINE AND WHITE PETROLATUMChurch & Dwight Co., Inc.b8699a40-8464-ca02-e053-2995a90a42602025-12-05WarningsExact identifier
application number: M017
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
application number: M017
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC4540221f-cf9f-9b6a-e063-6294a90adec32025-12-05WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLCb3ec09b9-7511-0895-e053-2a95a90a78402025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
application number: M017
BLT Skin CreamBENZOCAINE, LIDOCAINE, TETRACAINEM2B Pharma LLC9dc5db9d-9e0a-cd28-e053-2995a90a6bf72025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
application number: M017
Pain RelievingTROLAMINE SALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb813262e-57c6-4d2c-8cc0-7a17f6f593432025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Extra Strength BodyMENTHOLGold Bond Co LLC7b75b7de-9c0b-4edf-b923-320f7d2bb1e62025-12-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNb0947381-c0db-4253-ab40-3d45603ae65d13
106258hydrocortisone 10 MG/ML Topical CreamSCDb0947381-c0db-4253-ab40-3d45603ae65d13
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYb0947381-c0db-4253-ab40-3d45603ae65d13
106258hydrocortisone 1 % Topical CreamSYb0947381-c0db-4253-ab40-3d45603ae65d13
106258hydrocortisone 1 GM per 100 GM Topical CreamSYb0947381-c0db-4253-ab40-3d45603ae65d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-091-01533290091011 TUBE in 1 BOX (53329-091-01) / 28.4 g in 1 TUBE1 tube2010-03-010000-00-00NoNoCurrent
53329-091-90533290091901.5 g in 1 PACKET (53329-091-90) 1.5 g2010-03-010000-00-00NoNoCurrent
53329-091-915332900919148 PACKET in 1 CARTON (53329-091-91) / 1.5 g in 1 PACKET (53329-091-90) 48 packet2010-03-010000-00-00NoNoCurrent
53329-091-9653329009196144 TUBE in 1 CASE (53329-091-96) / 28.4 g in 1 TUBE144 tube2010-03-010000-00-00NoNoCurrent