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 |
|---|---|---|---|---|---|---|
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | da338796-de9c-be51-e053-2a95a90a2509 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Eagle Indo Pharma | e2c5f821-cdd5-190d-e053-2a95a90a9159 | 2024-10-07 | Warnings | M017 |
| NanoXtreme Pain Relieving | MENTHOL, METHYL SALICYLATE | MG Science Technologies LLC | c1490c30-a9db-4120-adaf-9e8000169e46 | 2024-10-07 | Warnings | M017 |
| CAREALL Hydrocortisone Maximum Strength | HYDROCORTISONE | New World Imports, Inc | ea656cf8-cad5-4fa5-82e7-daec77a0bb04 | 2024-10-07 | Warnings | M017 |
| Eagle Medicated Oil Refreshing | MENTHOL, METHYL SALICYLATE | Eagle Indo Pharma, PT | e2729023-d689-7ae2-e053-2a95a90a78dc | 2024-10-06 | Warnings | M017 |
| Flanax Back Pain Relief | LIDOCAINE | Belmora LLC | 46d33346-e582-4af1-b81a-feca7033dceb | 2024-10-04 | Warnings | M017 |
| Muscle Balm | MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) | Natural Essentials, Inc. | 16918ba3-2e07-4232-9ed3-4c7751796cd2 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Pain Relieving Continuous | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 998a4824-9ed9-4fe0-b45b-72e52861fcd3 | 2024-10-04 | Warnings | M017 |
| Fast Freeze Lidocaine Roll-On | LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL | Natural Essentials, Inc. | 74b06366-5eb4-4eba-aa2b-2b672828294d | 2024-10-04 | Warnings | M017 |
| Fast Freeze Lidocaine | LIDOCAINE | Natural Essentials, Inc. | 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f | 2024-10-04 | Warnings | M017 |
| Fast Freeze | MENTHOL | Natural Essentials Inc. | a96e3e41-871c-4cf3-93b6-af2a6246ded8 | 2024-10-04 | Warnings | M017 |
| CVS Pain Relief | MENTHOL 4% | CVS | 20234356-5e80-b79e-e063-6294a90a2ee3 | 2024-10-04 | Warnings | M017 |
| FLANAX BACK PAIN RELIEF | LIDOCAINE | Belmora Llc | af4bf57c-f250-4506-83eb-e0f253e96062 | 2024-10-04 | Warnings | M017 |
| topcare hydrocortisone | HYDROCORTISONE | Topco Associates LLC | 11a30ec9-ebc2-4a00-8a8d-431d0d973b37 | 2024-10-03 | Warnings | M017 |
| pain relief patch | LIDOCAINE 4% | Bionpharma Inc. | 19c69983-4e78-8ec5-e063-6394a90a84be | 2024-10-03 | 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 |