Anti-itch

Product NDC: 53329-091
11-digit product format: 533290091
Labeler code: 53329
Product ID: 53329-091_40c054e1-8661-4940-e063-6294a90a0200
Type: HUMAN OTC DRUG
Nonproprietary name: hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-03-01
Substance: HYDROCORTISONE
Active strength: 10 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Anti-itch
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 mg/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
b0947381-c0db-4253-ab40-3d45603ae65d	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, Related label table
NDC	Effective	Related label
53329-091-01	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-01	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-08-08	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-01	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-01	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-07-28	091 Curad Hydrocortisone 1% Cream Anti-itch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-091-01	Anti-itch	28.4 g in 1 TUBE	CREAM	28.4	13
53329-091-01	Anti-itch	1 in 1 BOX	CREAM	1	13
53329-091-90	Anti-itch	1.5 g in 1 PACKET	CREAM	1.5	13
53329-091-91	Anti-itch	48 in 1 CARTON	CREAM	48	13
53329-091-96	Anti-itch	144 in 1 CASE	CREAM	144	13
53329-091-96	Anti-itch	28.4 g in 1 TUBE	CREAM	28.4	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-091-01	GM - Gram	53329-091	9ab0f641-eef6-4977-a15b-abc165bf39b7	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
GLYCERYL STEARATE CITRATE	INACTIVE INGREDIENT	WH8T92A065	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-091	ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, LP]	13	Current NDC, Legacy NDC, 6 package rows	20250112_b0947381-c0db-4253-ab40-3d45603ae65d.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 91 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaD ANTI-ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	8f4a57cb-0a5b-42b0-a325-1f92f3942ad9	2025-05-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	b679ed7b-9d88-4eff-9743-567affe0fe2b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll On	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	28eb8273-5789-4f33-bbbe-3a5ec7bc7929	2025-05-27	Warnings	Exact identifier application number: M017
AUVON Pain Relief Cream	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	358c2632-3b90-1c54-e063-6294a90ad461	2025-05-22	Warnings	Exact identifier application number: M017
WelAhead by Welmate Lidocaine 5% Roll-on	LIDOCAINE 5%	OTC PHARM LLC	0b75e83e-8c7b-6247-e063-6294a90ac413	2025-05-21	Warnings	Exact identifier application number: M017
Bliss Republic	LIDOCAINE NUMBING EXTRA STRENGTH CREAM	Sargass Group Limited Liability Company	35aba13a-95e6-a395-e063-6294a90a5bdc	2025-05-21	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	e911478f-7153-4700-b945-92ec54972f45	2025-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Preferred Pharmaceuticals Inc.	0976a898-8d79-4b85-b473-c8ad32b4fd00	2025-05-20	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	359884d6-188a-e503-e063-6294a90acab4	2025-05-20	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO - THERMOACTIVE LOTION	835abc66-680f-be06-e053-2a91aa0a309e	2025-05-19	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	35884644-d017-eda3-e063-6394a90a1f6c	2025-05-19	Warnings	Exact identifier application number: M017
QUIT SMOKING Proven Patches	NICOTINE	Jiashen International Trade Limited	35570155-c769-dc4c-e063-6394a90a019d	2025-05-17	Warnings	Exact identifier application number: M017
VBBV Tattoo Numbing	LIDOCAINE	Jiashen International Trade Limited	3557859e-f8b3-1049-e063-6394a90ad737	2025-05-17	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	35415851-beba-5bb4-e063-6294a90a35c0	2025-05-16	Warnings	Exact identifier application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	352798e1-1e09-3d47-e063-6394a90ad404	2025-05-15	Warnings	Exact identifier application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	35285d62-c660-a056-e063-6294a90aabc8	2025-05-15	Warnings	Exact identifier application number: M017
SionBiotext Hydrocortisone	HYDROCORTISONE ACETATE 1%	Sion Biotext Medical Ltd	35073eae-26fe-2bb5-e063-6294a90ab56a	2025-05-13	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	3508ae14-d9c9-3c85-e063-6294a90a0098	2025-05-13	Warnings	Exact identifier application number: M017
SORE NO MORE WARM THERAPY	MENTHOL AND CAMPHOR	SOMBRA COSMETICS INC.	cd86b56e-9b4c-4aca-9740-c8793cb12055	2025-05-12	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	b0947381-c0db-4253-ab40-3d45603ae65d	13
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	b0947381-c0db-4253-ab40-3d45603ae65d	13
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	b0947381-c0db-4253-ab40-3d45603ae65d	13
106258	hydrocortisone 1 % Topical Cream	SY	b0947381-c0db-4253-ab40-3d45603ae65d	13
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	b0947381-c0db-4253-ab40-3d45603ae65d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-091-01	53329009101	1 TUBE in 1 BOX (53329-091-01) / 28.4 g in 1 TUBE	1 tube	2010-03-01	0000-00-00	No	No	Current
53329-091-90	53329009190	1.5 g in 1 PACKET (53329-091-90)	1.5 g	2010-03-01	0000-00-00	No	No	Current
53329-091-91	53329009191	48 PACKET in 1 CARTON (53329-091-91) / 1.5 g in 1 PACKET (53329-091-90)	48 packet	2010-03-01	0000-00-00	No	No	Current
53329-091-96	53329009196	144 TUBE in 1 CASE (53329-091-96) / 28.4 g in 1 TUBE	144 tube	2010-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
091 Curad Hydrocortisone 1% Cream Anti-itch	Medline Industries, LP	2025-10-09	HUMAN OTC DRUG LABEL	14