FDA.reportPublic FDA data

Anti-itch

Product NDC
72663-580
Requested package NDC
72663-580-02
11-digit product format
726630580
Labeler code
72663
Product ID
72663-580_fdf38eb0-b5eb-41b9-9d9e-6043bd1ed14d
Type
HUMAN OTC DRUG
Nonproprietary name
hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Welly Health PCB
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-02-25
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
1 g/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72663-58072663-580-02IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct 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
b6082387-f592-1148-0844-bd068fd213fbProduct 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72663-580-022022-01-28C16284748780-1d6a99b39-9e58-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72663-580-02Welly First Aid Kit0.9 mL in 1 POUCHCREAM4.5 mL1 g in 1mL4
72663-580-02Anti-itch0.9 mL in 1 POUCHCREAM0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72663-580ANTI-ITCH (HYDROCORTISONE) CREAM [WELLY HEALTH PCB]1Legacy NDC, 1 package rows20190225_a90e7759-c697-4b3c-bdb6-fd3a343e8e7e.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Welly First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, IBUPROFENWelly Health PBC11432329-12a1-4d73-b038-912175a49d092025-05-11WarningsExact identifier
ndc (package): 72663-580-02
ndc11 (package): 72663058002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616762ethanol 66.5 % Topical GelPSN55f717e6-764e-444c-aa70-517174b7553f6
616762ethanol 0.665 ML/ML Topical GelSCD55f717e6-764e-444c-aa70-517174b7553f6
616762ethanol 66.5 % Topical GelSY55f717e6-764e-444c-aa70-517174b7553f6
310965ibuprofen 200 MG Oral TabletPSN11432329-12a1-4d73-b038-912175a49d094
310965ibuprofen 200 MG Oral TabletSCD11432329-12a1-4d73-b038-912175a49d094
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY11432329-12a1-4d73-b038-912175a49d094
616762ethanol 66.5 % Topical GelPSNd4186754-ed6a-4c59-b841-8f4d7b880cd13
310965ibuprofen 200 MG Oral TabletPSN28349109-649b-40a7-bfe7-c910061bc30b3
616762ethanol 0.665 ML/ML Topical GelSCDd4186754-ed6a-4c59-b841-8f4d7b880cd13
310965ibuprofen 200 MG Oral TabletSCD28349109-649b-40a7-bfe7-c910061bc30b3
616762ethanol 66.5 % Topical GelSYd4186754-ed6a-4c59-b841-8f4d7b880cd13
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY28349109-649b-40a7-bfe7-c910061bc30b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72663-580-0272663058002.9 mL in 1 POUCH (72663-580-02) 2019-02-250000-00-00NoNoCurrent