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		2026-10-12

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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	METHYL SALICYLATE 10% GEL PATCH	Dr. Sabharwal's Wound Care	4a7790bb-25cb-72b8-e063-6294a90a6b9c	2026-06-29	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Target Corporation	36602b7a-99c0-f6a4-e063-6294a90a8758	2026-06-29	Warnings	Exact identifier application number: M017
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Unishield	f86f7446-b741-9f40-e053-6394a90a4422	2026-06-29	Warnings	Exact identifier application number: M017
MQ Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5560cdab-cee8-f6ec-e063-6294a90ad024	2026-06-29	Warnings	Exact identifier application number: M017
GNP Lidocaine Maximum Strength	LIDOCAINE HCL	AMERISOURCE BERGEN	9f559c20-c9ac-e480-e053-2a95a90a8fce	2026-06-29	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	5553385d-c1e6-1242-e063-6394a90aa5a7	2026-06-28	Warnings	Exact identifier application number: M017
MOROVAN	LIDOCAINE	HONG KONG UNORDERED TRADING CO., LIMITED	550c8d2d-e0d7-1531-e063-6394a90a374d	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas, LLC	5517ee5f-1c51-cfd6-e063-6294a90af56f	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas LLC	55188ede-68cd-fcc6-e063-6394a90a5c58	2026-06-25	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	NuCare Pharmaceuticals, Inc.	54f07a23-213f-ca46-e063-6394a90a0034	2026-06-24	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	MENTHOL,PRAMOXINE HYDROCHLORIDE	Rida LLC	b62d09e4-7ced-49a9-8c83-3a8ef580f25a	2026-06-23	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	PRAMOXINE HYDROCHLORIDE	Rida LLC	5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2	2026-06-23	Warnings	Exact identifier application number: M017
Pain Relieving cleansing spary	BENZALKONIUM CHLORIDE AND LIDOCAINE HCI	Trifecta Pharmaceuticals USA, LLC.	48edbb8d-0c35-91d8-e063-6394a90a71b8	2026-06-19	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL	Trifecta Pharmaceuticals USA, LLC.	493ab515-5cda-7b5a-e063-6294a90a295b	2026-06-19	Warnings	Exact identifier application number: M017
Tiger Balm Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	011fc383-10bc-44cf-a67c-4be45fef33e0	2026-06-19	Warnings	Exact identifier application number: M017
CVS Health Scalp Relief	SALICYLIC ACID	CVS Health	8de46015-817c-4cd9-95f8-293424f2a5c4	2026-06-19	Warnings	Exact identifier application number: M017
Careland Kinesiology Dual Action Pain Relieving Tape	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	67e0b3c5-e88e-4c48-a1e8-39f502ac249d	2026-06-18	Warnings	Exact identifier application number: M017
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	549348ec-2eb2-3781-e063-6294a90a2f4a	2026-06-18	Warnings	Exact identifier application number: M017
SprayPain Away	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	c603e999-2316-496a-e053-2995a90ab4ed	2026-06-17	Warnings	Exact identifier application number: M017
SprayPain Away Lavender	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	547e2167-ade0-ac7e-e063-6294a90a18ea	2026-06-17	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