FDA.reportPublic FDA data

Xpect Hydrocortisone

Product NDC
42961-220
11-digit product format
429610220
Labeler code
42961
Product ID
42961-220_c0e92b32-5811-4ec3-bb82-66819d42f2c1
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-Itch
Dosage form
CREAM
Route
TOPICAL
Labeler
Cintas Corp
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-03-28
Marketing end
0000-00-00
Substance
HYDROCORTISONE ACETATE
Active strength
0 g/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42961-220DDiscontinued by firm2026-10-05
excluded packagepackage42961-22042961-220-02DDiscontinued by firm2026-10-05
excluded packagepackage42961-22042961-220-03DDiscontinued by firm2026-10-05
excluded packagepackage42961-22042961-220-04DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
42961-220-01Xpect Hydrocortisone0.9 g in 1 PACKETCREAM0.95
42961-220-02Xpect Hydrocortisone20 in 1 BOXCREAM205
42961-220-03Xpect Hydrocortisone8 in 1 BOXCREAM85
42961-220-04Xpect Hydrocortisone144 in 1 BOXCREAM1445

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-220XPECT HYDROCORTISONE (ANTI-ITCH) CREAM [CINTAS CORP]4Legacy NDC, 4 package rows20241228_f0d1b1f7-5a62-4491-b508-91af16649dc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSNe6a0968f-5341-f7e1-e053-2995a90ae9521
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCDe6a0968f-5341-f7e1-e053-2995a90ae9521
1043690hydrocortisone acetate 1 % Topical CreamSYe6a0968f-5341-f7e1-e053-2995a90ae9521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-220-01429610220010.9 g in 1 PACKET0.9 gHistorical
42961-220-024296102200220 PACKET in 1 BOX (42961-220-02) > .9 g in 1 PACKET (42961-220-01) 20 packet2022-03-280000-00-00NoNoCurrent
42961-220-03429610220038 PACKET in 1 BOX (42961-220-03) > .9 g in 1 PACKET (42961-220-01) 8 packet2022-03-280000-00-00NoNoCurrent
42961-220-0442961022004144 PACKET in 1 BOX (42961-220-04) > .9 g in 1 PACKET (42961-220-01) 144 packet2022-03-280000-00-00NoNoCurrent