Hydrocortisone
- Product NDC
- 51672-5335
- 11-digit product format
- 516725335
- Labeler code
- 51672
- Product ID
- 51672-5335_5933787d-8cc1-5959-e063-6394a90a9f80
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone Cream 1/2%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-31
- Substance
- HYDROCORTISONE
- Active strength
- .5 g/100g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Hydrocortisone
- Brand name suffix
- with Aloe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | .5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198707 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 59337940-c9be-58af-e063-6394a90abe13 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Magsoothium Body | MENTHOL, CAPSAICIN | Ubu/Elements, Inc. | f604d30c-b17c-ec01-e053-2a95a90aa304 | 2025-12-15 | Warnings | M017 |
| Salonpas pain relieving JET | MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | dd1ea3bf-891a-402e-8f43-14302bc9c3e5 | 2025-12-15 | Warnings | M017 |
| Herbal Tendon Bone Relief | CAMPHOR MINT | Guchutang Biotechnology (Longyan) Co., Ltd. | 45cf4040-9751-d24b-e063-6294a90aff27 | 2025-12-13 | Warnings | M017 |
| ElixirLidoFast | LIDOCAINE 5% CREAM | ELIXIR HEALTHCARE USA, LLC. | 45de5a3d-06c2-aa02-e063-6294a90a63d3 | 2025-12-13 | Warnings | M017 |
| MEDI FIRST PLUS | HYDROCORTISONE ACETATE | Orazen Inc | 5781124a-60f4-4a64-80b7-ce5f28d495b5 | 2025-12-12 | Warnings | M017 |
| MEDI-FIRST | HYDROCORTISONE ACETATE | Orazen Inc | aeffd85c-58a7-4d64-bf94-977b6fbbe713 | 2025-12-12 | Warnings | M017 |
| Joint and Muscle Relief | MENTHOL | Smart Cookie Solutions Inc. | 45c24d56-4dc9-2884-e063-6294a90a52cc | 2025-12-12 | Warnings | M017 |
| Popstar | DELAY SPRAY | Pineapple Brands LLC | 293b2da9-1261-0358-e063-6394a90aa08c | 2025-12-12 | Warnings | M017 |
| Careland Pain Relief Plus | CAMPHOR, MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | d9e63ddd-d003-45fa-b156-7f4452c28cbd | 2025-12-12 | Warnings | M017 |
| Glucosamine Cream EXTRA STRENGTH | HISTAMINE DIHYDROCHLORIDE | IDEAZ, LLC | f4d414b7-89e7-ad65-e053-2a95a90a25d4 | 2025-12-12 | Warnings | M017 |
| ARTHRITIS | MENTHOL | Smith Amish, LLC | 20c36972-b695-1241-e063-6394a90adf63 | 2025-12-12 | Warnings | M017 |
| FOOT | MENTHOL | Smith Amish, LLC | 20c48537-f55f-c10f-e063-6394a90a4cca | 2025-12-12 | Warnings | M017 |
| Joint Ease | MENTHOL | Smith Amish, LLC | 20c4a0f8-bdc6-d89a-e063-6294a90aa8d8 | 2025-12-12 | Warnings | M017 |
| Toast Screamin Hot | CAPSAICIN | IDEAZ, LLC | 331207e6-b8ac-b169-e063-6394a90ac169 | 2025-12-12 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE | KORVIA GLOBAL Inc. | 45ccfcae-a307-1c5f-e063-6294a90acf89 | 2025-12-12 | Warnings | M017 |
| Lidospot patch | LIDOCAINE AND MENTHOL | Fabrication Enterprises Inc | 3a6e94c4-1ca6-e77a-e063-6394a90a4bfc | 2025-12-12 | Warnings | M017 |
| LETEBEE LIGHT neuropathy pain relief cream for feet | MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 45a99afc-15ec-76c2-e063-6294a90a2220 | 2025-12-11 | Warnings | M017 |
| Cinthera | LIDOCAINE | Strand Health Group | 2746e5b2-be2d-f2d2-e063-6394a90a3690 | 2025-12-11 | Warnings | M017 |
| Equate Cool and Heat Pain Relieving Liquid | COOL AND HEAT PAIN RELIEF | Walmart, Inc. | ad156685-3bd5-6837-e053-2995a90ac788 | 2025-12-11 | Warnings | M017 |
| HUMCO Camphor Spirit | CAMPHOR 10% | Humco Holding Group, Inc. | 9a0ef0a3-3c79-41b2-8193-424a3ef9886f | 2025-12-11 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51672-5335-2 | 51672533502 | 1 TUBE in 1 CARTON (51672-5335-2) / 28.4 g in 1 TUBE | 1 tube | 2026-07-31 | No | No | Current |