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 date	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`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
Ingredient	Strength
HYDROCORTISONE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106258	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0431a6af-4c9a-4bbd-a535-cba31a5e53cc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37012-059-02	2024-11-12	C162847	48780-1	9d75b9d0-ff6a-f424-e053-dadaa90a57ce	Shopko ® Hydrocortisone Cream 1% Maximum Strength
37012-059-02	2020-01-31	C162847	48780-1	9d75b9d0-ff6a-f424-e053-dadaa90a57ce	Shopko ® Hydrocortisone Cream 1% Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37012-059-02	Shopko HydrocortisoneMaximum Strength	1 in 1 CARTON	CREAM	1		3
37012-059-02	Shopko HydrocortisoneMaximum Strength	28.4 g in 1 TUBE	CREAM	28.4		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
sodium cetostearyl sulfate	INACTIVE INGREDIENT	7ZBS06BH4B	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37012-059	SHOPKO HYDROCORTISONE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [SHOPKO STORES OPERATING CO., LLC]	2	Current NDC, Legacy NDC, 2 package rows	20241114_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 80 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving	MENTHOL, CAMPHOR, CAPSAICIN	AHC VENTURES CORP DBA CRY	27679d31-a5f3-417b-b0c5-5f6b001ecff9	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	52fff03e-eba2-4604-a71c-2522468f627b	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	de210c3a-c24e-cefd-e053-2a95a90a93ff	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, CAMPHOR, CAPSAICIN	AHC VENTURES CORP DBA CRY	799751f3-726a-42de-934e-dbc3cd1cb8b8	2025-09-02	Warnings	Exact identifier application number: M017
Pain Relieving Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	de0c9a73-dbc0-599e-e053-2a95a90a7986	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC VENTURES CORP DBA CRYODERM	90334420-5f81-4284-9a57-42e134ce362f	2025-09-02	Warnings	Exact identifier application number: M017
KNEE PAIN RELIRF Patch	CAMPHOR, MENTHOL	Shenzhen Finona Information Technology Co., Ltd	3db971ef-d7fa-0171-e063-6294a90aa58b	2025-09-01	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Creme	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	300ac57e-844a-4840-b285-41ff5518e6b6	2025-08-29	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Gel	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	30b85890-e72d-4af7-bda9-e7744abc92af	2025-08-29	Warnings	Exact identifier application number: M017
Sumifun Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3d7dc8cc-0680-d94d-e063-6394a90ac8e8	2025-08-29	Warnings	Exact identifier application number: M017
TKTALKER NUMBING	NUMBING	Shenzhen Shandian Jingling Technology Co., Ltd.	3d7e6757-f183-2a68-e063-6294a90ae4ca	2025-08-29	Warnings	Exact identifier application number: M017
PBZ OTC	TRIPELENNAMINE HCL 1%	Kingsway Pharmaceuticals dba NFI, LLC	12f72d74-018f-4bc6-acd4-175ca3af4c6d	2025-08-29	Warnings	Exact identifier application number: M017
else.	LIDOCAINE	Else Co.	3d6c7b10-ed03-bbde-e063-6294a90ae92f	2025-08-28	Warnings	Exact identifier application number: M017
Mountain Ice Pain Relief	MENTHOL	Mountainside Medical Equipment, Inc.	c79fdd91-16f4-4ae0-bee4-d37c05ed2074	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise 4% Lidocaine Cream 2.7 oz	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	f39eb3d0-e153-4f50-85b1-ad5c677d176c	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise Overnight Menthol Patch	MENTHOL	Veridian Healthcare	6379f50d-2878-46ca-8acb-71c4554585e9	2025-08-28	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	PHARMACURE LLC	119bab58-f129-4ff0-8d81-9c6a7b508dd6	2025-08-28	Warnings	Exact identifier application number: M017
Anti Itch Maximum Relief	PRAMOXINE HYDROCHLORIDE AND MENTHOL	Natureplex LLC	75de3d5e-ecbe-4d04-a39d-792200e6ee32	2025-08-28	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	3d5718f3-c175-6b64-e063-6394a90aa6f1	2025-08-27	Warnings	Exact identifier application number: M017
ARCTIC HEAT	MENTHOL, METHYL SALICYLATE	Renu Laboratories, LLC	402df5c1-b8cb-17a2-e054-00144ff8d46c	2025-08-27	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	3
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	3
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	3
106258	hydrocortisone 1 % Topical Cream	SY	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	3
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
37012-059-02	37012005902	1 TUBE in 1 CARTON (37012-059-02) / 28.4 g in 1 TUBE	1 tube	1995-08-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Shopko ® Hydrocortisone Cream 1% Maximum Strength	Shopko Stores Operating Co., LLC \| Sun Pharma Canada Inc.	2025-07-15	HUMAN OTC DRUG LABEL	3