Hydrocortisone
- Product NDC
- 51672-5335
- Requested package NDC
- 51672-5335-2
- 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 |
|---|---|---|---|---|---|---|
| Dragon Pain Relieving Balm | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d129641-eaea-c3ee-e063-6394a90aa58f | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d1059cc-1b0b-4e7b-e063-6294a90a56ea | 2025-11-24 | Warnings | M017 |
| GuruNanda Pain Relief | MENTHOL AND CAMPHOR | GURUNANDA, LLC | 3ca78342-cc6d-5f6b-e063-6294a90a3f1c | 2025-11-24 | Warnings | M017 |
| Dragon Pain Relieving | CAMPHOR, MENTHOL | AMERICANNA WELLNESS, INC. | 0d118256-90ee-28ef-e063-6394a90a21e8 | 2025-11-24 | Warnings | M017 |
| health beyond | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af | 2025-11-23 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 3 Step | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 4429fea8-46f8-8f7f-e063-6394a90a34b4 | 2025-11-22 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 2 Step | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 442a926b-d7c1-4e35-e063-6394a90ad948 | 2025-11-22 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 1 Step | NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 442aae32-4ac6-5dd6-e063-6294a90aad02 | 2025-11-22 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches 1-3 Step | 21MG NICOTINE PATCHES | Shenzhen Paxi Trading Co., Ltd. | 442ae0fa-a1ed-7901-e063-6294a90ab717 | 2025-11-22 | Warnings | M017 |
| IceQuake Lidocaine Analgesic | LIDOCAINE HYDROCHLORIDE | Dextrum Laboratories, Inc | 441daa6f-f273-ac09-e063-6394a90a252c | 2025-11-21 | Warnings | M017 |
| Nighttime 4X Medicated Cream | BENZOCAINE | Rite Aid | 21645ed1-2dc0-223a-e063-6394a90ab021 | 2025-11-21 | Warnings | M017 |
| 4x Medicated Gum Cream | BENZOCAINE | Albertsons | b81a308c-9c30-0e3d-e053-2a95a90a15d2 | 2025-11-21 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | b0edd9d9-951f-d3dd-e053-2995a90a8d5a | 2025-11-21 | Warnings | M017 |
| Up up | LIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHES | Target Corporation | 44121d40-86e1-0df6-e063-6294a90aedaf | 2025-11-20 | Warnings | M017 |
| Up up | PAIN RELIEF ADVANCED HYDROGEL PATCHES | Target Corporation | 44128b70-3172-ee37-e063-6294a90a705f | 2025-11-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | f03090fa-f7e6-f53a-e053-2a95a90aa819 | 2025-11-20 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | ff073e47-3107-e17e-e053-6294a90a58fa | 2025-11-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | fc8a8f20-97ab-481e-e053-6394a90a3525 | 2025-11-20 | Warnings | M017 |
| FOOT PAIN RELIEF ROLL-ON | LIDOCAINE, MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 43edcea0-ab04-f368-e063-6294a90a817a | 2025-11-19 | Warnings | M017 |
| Absolut Skin Corticosoothe Anti-Itch | HYDROCORTISONE | Absolut Skin Incorporated | deb52218-9176-4aaa-a22f-b66dada6690f | 2025-11-19 | 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 |