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 |
|---|---|---|---|---|---|---|
| DDM Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Discount Drug Mart | 5d56c74f-604d-4fed-e053-2a91aa0a417c | 2023-12-19 | Warnings | M017 |
| HEB Camphor Phenol | CAMPHOR 10.8% AND PHENOL 4.7% | H E B | 5d573883-001d-e5a4-e053-2991aa0a6203 | 2023-12-18 | Warnings | M017 |
| Petrocort Antipruritic Lip 21 | HYDROCORTISONE | Clinical Formula LLC | 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b | 2023-12-15 | Warnings | M017 |
| DermaWound Wound Care Venous Stasis | BENZOCAINE HYDROCHLORIDE | Progressive Doctors, LLC | 6221ba86-8b7f-48c8-8284-6950f9fc36b1 | 2023-12-15 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Humco Holding Group, Inc. | a8be9e46-1616-40a9-e053-2a95a90ac3bc | 2023-12-15 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Humco Holding Group, Inc | a8bf9744-9979-13c1-e053-2a95a90a30aa | 2023-12-15 | Warnings | M017 |
| Freds Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Discount Drug Mart | 8697b932-da5a-717e-e053-2a91aa0afcae | 2023-12-12 | Warnings | M017 |
| CVS Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | CVS | 86972218-31fe-6942-e053-2991aa0a8850 | 2023-12-12 | Warnings | M017 |
| Best Choice Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | value merchandisers | 869631f8-aa1e-8ea4-e053-2a91aa0a5c57 | 2023-12-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Weeks & Leo Co., Inc. | 0c5325e3-4796-856c-e063-6394a90a1f90 | 2023-12-12 | Warnings | M017 |
| Westlake Anti-itch | HYDROCORTISONE | Westlake Pharma LLC | 0c53c982-3f23-a2d5-e063-6394a90acd55 | 2023-12-12 | Warnings | M017 |
| Rite Aid Anti-itch | HYDROCORTISONE | Rite Aid | 0c540422-1579-9217-e063-6294a90ad06a | 2023-12-12 | Warnings | M017 |
| Anti-itch Paraben Free | HYDROCORTISONE | Weeks & Leo Co., Inc. | 0c5419c5-0929-7ca6-e063-6294a90ac0a7 | 2023-12-12 | Warnings | M017 |
| Rite Aid Hydrocortisone | HYDROCORTISONE 1% | Rite Aid | 0c580f96-7fe9-19df-e063-6394a90a5a22 | 2023-12-12 | Warnings | M017 |
| Anti itch | HYDROCORTISONE | Weeks & Leo Co., Inc. | 0c58b750-d3a6-5ed1-e063-6294a90a4321 | 2023-12-12 | Warnings | M017 |
| Greencaine Blast | LIDOCAINE | ALMA Laboratories, Inc. | 031e0065-4c8a-43d8-bc69-3efa3c6c0ae3 | 2023-12-12 | Warnings | M017 |
| Ageless Pain Relief | METHYL SALICYLATE, MENTHOL | Isagenix International, LLC | 3c7e493b-923d-44b1-9076-46c7894308d4 | 2023-12-12 | Warnings, Adverse reactions | M017 |
| CVS Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | CVS | 857af609-9dd7-a07a-e053-2991aa0ab6ba | 2023-12-11 | Warnings | M017 |
| Rite Aid Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rite Aid | 0c4170dd-e1fa-d549-e063-6394a90a5c23 | 2023-12-11 | Warnings | M017 |
| Westlake Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Westlake HB Pharma LLC | 0c416ba6-b01f-0609-e063-6294a90ae2a1 | 2023-12-11 | 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 |