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 |
|---|---|---|---|---|---|---|
| Thera Plus Cool and Heat Pain Relieving Gel Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2023-11-30 | Warnings | M017 |
| Bloop Itch Soothing Topical | HYDROCORTISONE | Three Nations Corp | 0b64677e-d4bf-0929-e063-6294a90af137 | 2023-11-30 | Warnings | M017 |
| Ice Quake | MENTHOL | Southern Sales & Service, Inc. | 7a05832f-49ac-4013-b240-4405501e45cd | 2023-11-29 | Warnings | M017 |
| ICE MUSCLE RUB Leon M.C | MENTHOL | Southern Sales & Service, Inc. | 4efaf347-7406-4690-8005-e7cf2e3d4222 | 2023-11-29 | Warnings | M017 |
| IceQuake Analgestic White | METHYL SALICYLATE, MENTHOL | Southern Sales & Service, Inc. | 54e5dcd5-9987-488d-a758-d0e76d155182 | 2023-11-29 | Warnings | M017 |
| Icequake Coldn Hot medicated patch | MENTHOL | Southern Sales & Service, Inc. | 89202c52-9eb7-4e5a-a709-4a66ab0d3a72 | 2023-11-29 | Warnings | M017 |
| IceQuake Lidocaine Analgesic | LIDOCAINE HYDROCHLORIDE | Southern Sales & Service, Inc. | 9089cb78-e9f8-4437-a767-df809a114c4b | 2023-11-29 | Warnings | M017 |
| Ice Quake Muscle Rub Blue | MENTHOL | Southern Sales & Service, Inc. | 5180f6a3-58f1-4c50-a33b-7d85a3c1b99b | 2023-11-29 | Warnings | M017 |
| Discount Drug Mart Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Discount Drug Mart | 8579df23-ac07-9df8-e053-2991aa0a8bbb | 2023-11-29 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf | 2023-11-28 | Warnings | M017 |
| Poli-A | HYDROCORTISONE ACETATE | Sato Pharmaceutical Co., Ltd. | e27a3840-d9de-4bd0-ad75-8a151bd12b83 | 2023-11-28 | Warnings | M017 |
| Sheffield Arthritis and Muscle Pain Relief | CAPSICUM OLEORESIN | Sheffield Pharmaceuticals LLC | 724b9870-e86a-4087-ba78-8c944ce3baa6 | 2023-11-28 | Warnings | M017 |
| Dr Sheffield Muscle Rub Cream | MUSCLE RUB CREAM | Sheffield Pharmaceuticals LLC | 60d1d826-a53e-42e5-bc30-1b2c2690445b | 2023-11-28 | Warnings | M017 |
| Thera Plus Cold Therapy Pain Relieving Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a462c91-5300-e282-e063-6394a90a4cc2 | 2023-11-27 | Warnings | M017 |
| UtaSpray | MENTHOL AND METHYL SALICYLATE | Big 5 Nutrition LLC | c641ab11-cd00-4e23-ace7-8178739084f0 | 2023-11-21 | Warnings | M017 |
| Top Medicated Oil | CAMPHOR, MENTHOL, METHYL SALICYLATE | Big 5 Nutrition LLC | b2f0d1e1-7d03-434e-be39-9f980459690c | 2023-11-21 | Warnings | M017 |
| BT Pain Relief Balm | METHYL SALICYLATE, MENTHOL, CAMPHOR | Big 5 Nutrition LLC | 50112419-c934-4d3a-9ea6-9b089f516a6d | 2023-11-21 | Warnings | M017 |
| BT Pain Relief | MENTHOL, METHYL SALICYLATE | Big 5 Nutrition LLC | 91324910-27cf-424f-9e9b-6173f2d7acbf | 2023-11-21 | Warnings | M017 |
| Dit Da Shui | MENTHOL AND METHYL SALICYLATE | Big 5 Nutrition LLC | 5d45cb48-3e88-4d58-81d2-6f88d7a82134 | 2023-11-20 | Warnings | M017 |
| Herbal Balm | METHYL SALICYLATE, MENTHOL AND | Big 5 Nutrition LLC | 09b3b86d-3434-428b-b0a8-e8dfd7c0b52a | 2023-11-20 | 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 |