Hydrocortisone Anti-Itch

Product NDC: 52000-022
11-digit product format: 520000022
Labeler code: 52000
Product ID: 52000-022_27c668e1-25bd-46e1-8651-d07ef4b61540
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Universal Distribution Center LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-09
Substance: HYDROCORTISONE
Active strength: .01 g/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52000-022		I	Inactivated by FDA		2026-10-21
excluded package	package	52000-022	52000-022-37	I	Inactivated by FDA		2026-10-21

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52000-022-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52000-022-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52000-022-37	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52000-022-37	`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: Hydrocortisone Anti-Itch
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	.01 g/g

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
186afb11-06b6-4bfa-e063-6294a90aefc6	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
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
52000-022-37	2025-07-29	C162847	48780-1	9d75b9cf-ed83-f424-e053-dadaa90a57ce	Hydrocortisone Anti-Itch Cream
52000-022-37	2020-12-10	C162847	48780-1	9d75b9cf-ed83-f424-e053-dadaa90a57ce	Hydrocortisone Anti-Itch Cream
52000-022-37	2020-01-31	C162847	48780-1	9d75b9cf-ed83-f424-e053-dadaa90a57ce	Hydrocortisone Anti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52000-022-38	Hydrocortisone Anti-Itch	14 g in 1 TUBE	CREAM	14	4
52000-022-39	Hydrocortisone Anti-Itch	1 in 1 BOX	CREAM	1	4
52000-022-36	Hydrocortisone Anti-Itch	14 g in 1 TUBE	CREAM	14	3
52000-022-37	Hydrocortisone Anti-Itch	1 in 1 BOX	CREAM	1	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52000-022	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241212_d44ee37a-305e-4adc-be42-4928d6771655.zip
52000-022	HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241220_186afb11-06b6-4bfa-e063-6294a90aefc6.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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RICHTOFIT RAPID ACTIVE ARTHRITIS	MENTHOL AND CAMPHOR	RICHTOFIT LIMITED LIABILITY COMPANY	4b1cdab1-3e50-4ec3-e063-6394a90af75e	2026-03-12	Warnings	Exact identifier application number: M017
5Kind DMSO 4 Lidocaine HCl Pain Relieving	LIDOCAINE HYDROCHLORIDE, MENTHOL	5KIND TRADING LTD	67d8d045-7fa0-46c2-8072-645d8823903b	2026-03-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca541b4-7afe-77c5-e063-6294a90ad692	2026-03-10	Warnings	Exact identifier application number: M017
Lidocaine Cream, 4%	LIDOCAINE	IPG PHARMACEUTICALS, INC.	7775bfdd-7eac-4f09-b83f-fc4a16a24558	2026-03-10	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4c989283-9a27-e8d2-e063-6294a90a8bfa	2026-03-09	Warnings	Exact identifier application number: M017
Prequel Anti-Itch Solution Medicated Calming	MEDICATED CALMING LOTION	The Center Brands, LLC	419fa45b-992b-676e-e063-6394a90add81	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	1fda69f7-2bb6-42fc-bcef-677e7b3d7f01	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee	MENTHOL, LAUROCAPRAM	Planet (Anhui) Pharmaceutical Co., Ltd.	7577625c-87eb-4639-aeab-8a2ab97033fd	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4	2026-03-09	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca35030-958c-8f62-e063-6294a90a4d63	2026-03-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA Corp	cff71b75-fc4e-29ac-e053-2995a90abd50	2026-03-06	Warnings	Exact identifier application number: M017
Heal and Rescue Bunion Pain Relief	LIDOCAINE HCL, MENTHOL	Rooftop Consumer Health, Inc	4c60d4d3-e0a9-6f93-e063-6394a90a16af	2026-03-06	Warnings	Exact identifier application number: M017
JUST CBD - PAIN RELIEF	MENTHOL, CAMPHOR	Just Brands LLC	4c493c0b-c58e-cb56-e063-6394a90a9395	2026-03-05	Warnings	Exact identifier application number: M017
Hug a BooBoo Medicated booboo Wipes	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	509aaafc-2ef7-4205-818c-7ff5b146e159	2026-03-04	Warnings	Exact identifier application number: M017
CVS Foot Pain	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4c3350c3-2e3e-093c-e063-6394a90a3475	2026-03-04	Warnings	Exact identifier application number: M017
Game On Sport	MENTHOL	Natural Essentials, Inc	4c3411dc-5378-bd93-e063-6394a90a8406	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	f4d4a56b-b4b7-9a07-e053-2a95a90ad853	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	9987165c-1a0f-dd57-e053-2a95a90ae735	2026-03-04	Warnings	Exact identifier application number: M017
Walgreens Unscented Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Walgreen Co.	41eadb4f-2ca5-42a1-e063-6294a90ab4e2	2026-03-04	Warnings	Exact identifier application number: M017
Careland Pain Relief Patch Plus	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3	2026-03-04	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	186afb11-06b6-4bfa-e063-6294a90aefc6	4
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	186afb11-06b6-4bfa-e063-6294a90aefc6	4
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	186afb11-06b6-4bfa-e063-6294a90aefc6	4
106258	hydrocortisone 1 % Topical Cream	SY	186afb11-06b6-4bfa-e063-6294a90aefc6	4
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	186afb11-06b6-4bfa-e063-6294a90aefc6	4
106258	hydrocortisone 1 % Topical Cream	PSN	d44ee37a-305e-4adc-be42-4928d6771655	3
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	d44ee37a-305e-4adc-be42-4928d6771655	3
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	d44ee37a-305e-4adc-be42-4928d6771655	3
106258	hydrocortisone 1 % Topical Cream	SY	d44ee37a-305e-4adc-be42-4928d6771655	3
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	d44ee37a-305e-4adc-be42-4928d6771655	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52000-022-36	52000002236	14 g in 1 TUBE	14 g					Historical
52000-022-37	52000002237	1 TUBE in 1 BOX (52000-022-37) > 14 g in 1 TUBE (52000-022-36)	1 tube	2020-12-09	0000-00-00	No	No	Current
52000-022-38	52000002238	14 g in 1 TUBE	14 g					Historical
52000-022-39	52000002239	1 TUBE in 1 BOX (52000-022-39) / 14 g in 1 TUBE (52000-022-38)	1 tube	2020-12-09		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocortisone Anti-Itch Cream	Universal Distribution Center LLC	2025-10-30	HUMAN OTC DRUG LABEL	4
Hydrocortisone Anti-Itch Cream	Universal Distribution Center LLC	2024-10-17	HUMAN OTC DRUG LABEL	3