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.
| 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.
| 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 |
|---|---|
| HYDROCORTISONE ACETATE | 1.12 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3X7931PO74 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 106258 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 28b06507-27a5-2cb1-e054-00144ff8d46c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | 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 | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Biofreeze Roll-On | MENTHOL | A-S Medication Solutions | 814b37ea-5441-4cec-8794-71ca01d849ae | 2023-10-30 | Warnings | M017 |
| Dr. Sheffield Hydrocortisone Anti itch | HYDROCORTISONE | Sheffield Pharmaceuticals LLC | 71c9f2f4-2188-45eb-b55e-3856ac78070b | 2023-10-30 | Warnings | M017 |
| Family Wellness | BENZOCAINE, RESORCINOL | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | df540eb8-6773-4647-9cc2-c3fd14d7355e | 2023-10-27 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE 1% | FRONT PHARMACEUTICAL PLC | ea26265d-f24e-458e-8bf0-287b2d49f4f4 | 2023-10-27 | Warnings | M017 |
| Joint Formula 88 MAX PLUS | CAMPHOR | Sarati International, Inc. | f5d78335-b78d-4909-a88b-9daa3c18ba15 | 2023-10-27 | Warnings | M017 |
| OsmoFlex | MENTHOL | Sarati International, Inc. | 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e | 2023-10-27 | Warnings | M017 |
| Thera plus Anti-itch with aloe Hydrocortisone | HYDROCORTISONE | Fourstar Group USA, Inc. | c69d0670-a65b-1680-e053-2995a90a2ee5 | 2023-10-26 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | FRONT PHARMACEUTICAL PLC | fde2069b-344e-46da-bb95-c5113e0f35d6 | 2023-10-26 | Warnings | M017 |
| MAXIMUM STRENGTH HEMORRHOIDAL RELIEF | LIDOCAINE | CVS PHARMACY, INC | b61424bf-3b23-420b-a7bc-256ddb96aa22 | 2023-10-25 | Warnings | M017 |
| Assured | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. | bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | b41091b4-0dc0-4a88-8ff6-11979b3d307a | 2023-10-25 | Warnings | M017 |
| Thera Plus | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | bcc99e5a-2403-46da-9c9d-8411fa4104e0 | 2023-10-25 | Warnings | M017 |
| Assured | LIDOCAINE HYDROCHLORIDE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c | 2023-10-25 | Warnings | M017 |
| Red hot | CAPSAICIN | The Hygenic Company, LLC | d100092c-e10b-2063-e053-2995a90aedb2 | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | c8d4ae28-efc4-6a00-e053-2a95a90a40bf | 2023-10-25 | Warnings | M017 |
| Cryo10 Topical Analgesic | MENTHOL | Element 26 LLC | ff1d2140-9302-918c-e053-6394a90acb9a | 2023-10-25 | Warnings | M017 |
| Stopain Clinical | MENTHOL | Troy Manufacturing, Inc. | 3336cc35-e773-4705-84b5-61040604beef | 2023-10-25 | Warnings | M017 |
| CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant | BENZOCAINE, WHITE PETROLATUM | Carma Laboratories, Inc. | bbf0abcd-b7d6-b5e4-e053-2995a90a5240 | 2023-10-25 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bbee66b9-39ff-4e7e-e053-2995a90a43be | 2023-10-25 | Warnings | M017 |
| XtraCare Ice Cold Topical Analgesic Gel | MENTHOL | Rejoice International | d38f3099-d940-44d8-aa7f-404157c5e0e3 | 2023-10-24 | Warnings | M017 |
DailyMed RxNorm Mappings#
| 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 | 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 |