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		2026-10-15

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 42 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Fast Acting Itch Relief Cooling	HYDROCORTISONE	Chattem, Inc.	01cd77e3-380f-4487-ae6e-3ac45355d8a4	2026-01-14	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	0174411c-1b10-4298-b820-87b24065b118	2026-01-14	Warnings	Exact identifier application number: M017
Cortizone 10 Intensive Healing for Eczema	HYDROCORTISONE	Chattem, Inc.	31dc0f1f-ddd8-41dc-b669-b24655634d55	2026-01-14	Warnings	Exact identifier application number: M017
Cortisone 10 Overnight Creme	HYDROCORTISONE	Chattem, Inc.	ef2eda7e-d6a8-47e3-9d80-6074af6773dc	2026-01-14	Warnings	Exact identifier application number: M017
CVS Pain Relief Lavender Scent	MENTHOL 4%	CVS	484b0833-9f8a-f155-e063-6294a90a1869	2026-01-13	Warnings	Exact identifier application number: M017
EARTHS CARE ANTI-ITCH	CAMPHOR (NATURAL), MENTHOL	DLC Laboratories, Inc.	d1eabb5f-7086-4ff0-a398-3703c9ecd441	2026-01-13	Warnings	Exact identifier application number: M017
HealthWise Cold Therapy Menthol Pain Relief	MENTHOL	Veridian Healthcare	25e3d9cd-6ba3-4e06-8853-324b9d669248	2026-01-13	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	1ac2ed54-194c-4de2-8e7f-6e74ca32aa40	2026-01-13	Warnings	Exact identifier application number: M017
Pain Release Joint and Arthritis Cream	MENTHOL	Saje Natural Business Inc.	18b24d75-17f7-1a35-e063-6394a90a55e0	2026-01-13	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	a32b0950-3467-4e37-988d-104836af5971	2026-01-13	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	92eec6e7-0367-43c6-bd28-1762390a7114	2026-01-13	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	481a493b-0620-46ac-8228-e9964b7eb24b	2026-01-13	Warnings	Exact identifier application number: M017
Restoral	MENTHOL	Saje Natural Business Inc.	5b6176c1-9ed9-1950-e053-2a91aa0a434e	2026-01-13	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Eucalyptus Essential Oil	LIDOCAINE HCL	Chattem, Inc.	03e247b4-a2e2-4354-a018-880f1bc987fd	2026-01-13	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine Foot (Diabetic)	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	2c33d15e-5032-46d9-bd98-5abc7df3bbe5	2026-01-13	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Essential Oils Rosemary Mint	LIDOCAINE	Chattem, Inc.	9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab	2026-01-13	Warnings	Exact identifier application number: M017
Capzasin HP Arthritis Pain Relief	CAPSAICIN	Chattem, Inc.	345c9159-0efe-436b-9068-3b717678936b	2026-01-13	Warnings	Exact identifier application number: M017
Capzasin Quick Relief	CAPSAICIN AND MENTHOL	Chattem, Inc.	d6c313a3-8dc6-4231-95b6-ac9399e1c1be	2026-01-13	Warnings	Exact identifier application number: M017
Aspercreme Pain Relieving	TROLAMINE SALICYLATE	Chattem, Inc.	97dd587b-ecc3-4b4b-a116-6355d3c6ea6d	2026-01-13	Warnings	Exact identifier application number: M017
Dr Wellskin Numbing Cream	4% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	482f25cc-dee3-c3b6-e063-6294a90a8674	2026-01-12	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