FDA.reportPublic FDA data

Shopko Hydrocortisone

Product NDC
37012-059
Requested package NDC
37012-059-02
11-digit product format
370120059
Labeler code
37012
Product ID
37012-059_39f939e2-f3e9-4839-e063-6394a90a0188
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Shopko Stores Operating Co., LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-08-23
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

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
Shopko Hydrocortisone
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

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
0431a6af-4c9a-4bbd-a535-cba31a5e53ccAvailable 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37012-059-022024-11-12C16284748780-19d75b9d0-ff6a-f424-e053-dadaa90a57ceShopko ® Hydrocortisone Cream 1% Maximum Strength
37012-059-022020-01-31C16284748780-19d75b9d0-ff6a-f424-e053-dadaa90a57ceShopko ® Hydrocortisone Cream 1% Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-059-02Shopko HydrocortisoneMaximum Strength1 in 1 CARTONCREAM13
37012-059-02Shopko HydrocortisoneMaximum Strength28.4 g in 1 TUBECREAM28.43

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZESHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1
waterINACTIVE INGREDIENT059QF0KO0RSHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-059SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]2Current NDC, Legacy NDC, 2 package rows20241114_0431a6af-4c9a-4bbd-a535-cba31a5e53cc.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 64 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JUST CBD - CBD AND THC ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLCf664eb79-8897-3a49-e053-2995a90a37b42025-11-17WarningsExact identifier
application number: M017
JUST CBD RELIEF SOOTHINGLIDOCAINE HCLJust Brands LLCf9aff6e7-5702-f61c-e053-6294a90aa66f2025-11-17WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC0abece07-976c-4881-e063-6294a90a5c1b2025-11-17WarningsExact identifier
application number: M017
Blue-Emu Thrive Pain Relief CreamTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLCa4ba6787-c99b-4bf2-9f8f-e923ef9762122025-11-14WarningsExact identifier
application number: M017
CVS Cooling PatchMENTHOLCVS Pharmacy42d97e29-f32d-a31b-e063-6394a90a88d82025-11-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
application number: M017
EXTREME EMUMENTHOL, METHYL SALICYLATERenu Laboratories, LLC4393b57b-1e70-b8dd-e063-6294a90ae7482025-11-14WarningsExact identifier
application number: M017
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINECVS0a5a8cd0-d680-8a0f-e063-6294a90aa65c2025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
application number: M017
4x Medicated Toothache and Gum CreamBENZOCAINEWalgreensa71c2092-4ece-b82e-e053-2995a90ac9332025-11-14WarningsExact identifier
application number: M017
After Bite Natural1.0% CAMPHORTender Corporation d/b/a Adventure Ready Brands2511efa5-0d30-6e8a-e063-6394a90a553c2025-11-14WarningsExact identifier
application number: M017
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN0431a6af-4c9a-4bbd-a535-cba31a5e53cc3
106258hydrocortisone 10 MG/ML Topical CreamSCD0431a6af-4c9a-4bbd-a535-cba31a5e53cc3
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY0431a6af-4c9a-4bbd-a535-cba31a5e53cc3
106258hydrocortisone 1 % Topical CreamSY0431a6af-4c9a-4bbd-a535-cba31a5e53cc3
106258hydrocortisone 1 GM per 100 GM Topical CreamSY0431a6af-4c9a-4bbd-a535-cba31a5e53cc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37012-059-02370120059021 TUBE in 1 CARTON (37012-059-02) / 28.4 g in 1 TUBE1 tube1995-08-23NoNoCurrent