Vanicream HC Anti-Itch

Product NDC: 45334-327
11-digit product format: 453340327
Labeler code: 45334
Product ID: 45334-327_4127509b-f9bd-2d67-e063-6394a90a291d
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Pharmaceutical Specialties, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-01-26
Marketing end: 2026-11-25
Substance: HYDROCORTISONE ACETATE
Active strength: 1.12 g/100g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45334-327	45334-327-04	D	Discontinued by firm		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 · 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
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…`

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: Vanicream HC Anti-Itch

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE ACETATE	1.12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3X7931PO74	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
28b06507-27a5-2cb1-e054-00144ff8d46c	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
6084a4f4-5437-c9a5-caec-5361ee075a59	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
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45334-327-02	Vanicream HC Anti-Itch	1 in 1 CARTON	CREAM	1	8
45334-327-02	Vanicream HC Anti-Itch	57 g in 1 TUBE	CREAM	57	8
45334-327-04	Vanicream HC Anti-Itch	4 g in 1 TUBE	CREAM	4	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45334-327-02	GM - Gram	45334-327	19f383b3-9112-4591-8ba5-7a15188c0297	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45334-327	VANICREAM HC ANTI-ITCH (HYDROCORTISONE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20241013_28b06507-27a5-2cb1-e054-00144ff8d46c.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 151 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fefbe351-1cd9-4a2f-a43d-51e2c4eb180b	2023-10-24	Warnings	Exact identifier application number: M017
TheraPlus Plus	MENTHOL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	d4119f84-eb60-4134-b58e-de13d9601199	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Exact identifier application number: M017
NUMOTIZINE	MENTHOL	Hobart Laboratories, Inc.	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	2023-10-20	Warnings	Exact identifier application number: M017
Numfast Tetracaine Green	TETRACAINE	Unit Dose, Ltd.	77d9e6ea-1cd3-4447-ba74-01cd7143e27c	2023-10-19	Warnings	Exact identifier application number: M017
Liprotek	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5	2023-10-19	Warnings	Exact identifier application number: M017
GENUINE FIRST AID Antiseptic Pain Relieving	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bc7c6739-6068-4694-adc9-0c0c5c347df4	2023-10-19	Warnings	Exact identifier application number: M017
CVS Itch relief moisturizing	PRAMOXINE HCL 1%	CVS Health	f3a753fc-f448-6bba-e053-2a95a90a8e1b	2023-10-18	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Asclemed USA, Inc.	e13984ea-73a9-2894-e053-2995a90a8ed6	2023-10-16	Warnings	Exact identifier application number: M017
EXOTEN-C	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Asclemed USA, Inc.	76ed37e0-64b5-4abe-a03c-3dc7084a3919	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo HP Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	89a8c267-bd92-4d0d-8e50-c52224aff9cd	2023-10-16	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Whitestone Products LLC	0e32e9c0-ff5b-4e88-89b1-f5903cd98209	2023-10-16	Warnings	Exact identifier application number: M017
Capsadyn	CAPSAICIN	Chorda Pharma, Inc	07731045-0d2b-76b7-e063-6294a90af921	2023-10-11	Warnings	Exact identifier application number: M017
WHITE FLOWER STRAIN RELIEF	CAMPHOR, MENTHOL AND METHYL SALICYLATE	HOE HIN PAK FAH YEOW MANUFACTORY LTD	65282267-de63-453a-a686-f8752c71b9ef	2023-10-02	Warnings	Exact identifier application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTED	CAMPHOR, MENTHOL AND METHYL SALICYLATE	HOE HIN PAK FAH YEOW MANUFACTORY LTD	4e9cb5aa-b0aa-4a5c-b561-cc38437758d8	2023-10-02	Warnings	Exact identifier application number: M017
NATUREANCE BODY BALM	CAMPHOR	EROS GLOBAL CORP	05b84fd2-8d8f-9249-e063-6294a90ae29f	2023-09-19	Warnings	Exact identifier application number: M017
U ICE COLD	MENTHOL	UNIVERSAL DISTRIBUTION CENTER LLC	752ef0cd-f12a-3b9e-e053-2991aa0abeb1	2023-09-01	Warnings	Exact identifier application number: M017
Family Wellness Pain Relief with Lidocaine	PAIN RELIEF WITH LIDOCAINE	FAMILY DOLLAR (Family Wellness)	3a18119f-6c75-4cea-a990-97cb8a9589d4	2023-08-29	Warnings	Exact identifier application number: M017
Bactine Max Antibiotic and Lidocaine Max Pain Relief	LIDOCAINE	WellSpring Pharmaceutical Corporation	71300df9-6113-4f25-93ca-28ad7e7f79de	2023-06-08	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3X7931PO74	HYDROCORTISONE ACETATE	50-03-3	HYDROCORTISONE ACETATE
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	28b06507-27a5-2cb1-e054-00144ff8d46c	8
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	28b06507-27a5-2cb1-e054-00144ff8d46c	8
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	28b06507-27a5-2cb1-e054-00144ff8d46c	8
106258	hydrocortisone 1 % Topical Cream	SY	28b06507-27a5-2cb1-e054-00144ff8d46c	8
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	28b06507-27a5-2cb1-e054-00144ff8d46c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45334-327-02	45334032702	1 TUBE in 1 CARTON (45334-327-02) / 57 g in 1 TUBE	1 tube	2016-01-26	2026-11-25	No	No	Current
45334-327-04	45334032704	4 g in 1 TUBE (45334-327-04)	4 g	2016-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VANICREAM™ HC Anti-Itch Cream	Pharmaceutical Specialties, Inc.	2025-10-14	HUMAN OTC DRUG LABEL	8