Hydrocortisone
- Product NDC
- 11673-392
- 11-digit product format
- 116730392
- Labeler code
- 11673
- Product ID
- 11673-392_58cc796c-9ea2-5927-e063-6394a90aaa0e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- TARGET Corporation
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-10-19
- Substance
- HYDROCORTISONE
- Active strength
- 1 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
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 11673-392-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 11673-392-02 | f5e01cc5f278… | a2eaf40c39c3… |
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 | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 106258 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11673-392-02 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2b80-fb37-e063-e6dba90a4e07 | Hydrocortisone with Aloe |
| 11673-392-02 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2b80-fb37-e063-e6dba90a4e07 | Hydrocortisone with Aloe |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-392-02 | Hydrocortisonewith Aloe | 1 in 1 CARTON | CREAM | 1 | 3 | |
| 11673-392-02 | Hydrocortisonewith Aloe | 28.4 g in 1 TUBE | CREAM | 28.4 | 3 |
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 |
|---|---|---|---|---|---|---|
| LidoPro Patch | LIDOCAINE, MENTHOL, AND METHYL SALICYLATE | Advanced Rx Pharmacy of Tennessee, LLC | 128d0ba9-bc9d-af16-e063-6394a90af5ef | 2024-02-29 | Warnings | M017 |
| Leader Roll-On Cooling Pain Relief Topical Analgesic | MENTHOL, UNSPECIFIED FORM | Cardinal Health, 110 dba LEADER | e86cba40-6b10-454d-98b3-6b547456eaad | 2024-02-29 | Warnings | M017 |
| Maximum Strength Scalp Itch Relief Anti-itch | HYDROCORTISONE | Rite Aid | 55569563-fc38-4f97-8e74-9f96e3173384 | 2024-02-28 | Warnings | M017 |
| Walgreens Eczema Relief | HYDROCORTISONE ACETATE | Walgreen Co. | 4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c | 2024-02-28 | Warnings | M017 |
| meijer Cold Therapy Pain Relieving analgesic | MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | fb163112-d84d-418d-a410-3214c0ee4b5a | 2024-02-28 | Warnings | M017 |
| SunBurnt PLUS | LIDOCAINE HYDROCHLORIDE | Quest Products, LLC. | 12128c75-015d-8a72-e063-6394a90ae00a | 2024-02-23 | Warnings | M017 |
| Kroger Analgesic Analgesic | LIDOCAINE HYDROCHLORIDE | THE KROGER CO | e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 | 2024-02-22 | Warnings | M017 |
| Rugby Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Bryant Ranch Prepack | fcf48536-224e-4a3d-9124-770031823972 | 2024-02-22 | Warnings | M017 |
| meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic | MENTHOL, UNSPECIFIED FORM | Meijer Distribution, Inc | 8bc3956b-b82d-4ed3-8bc3-db0078466bbc | 2024-02-22 | Warnings | M017 |
| Promescent Delay Wipes | BENZOCAINE | Absorption | f0a5b6be-acc5-473c-9054-b9534e769db1 | 2024-02-20 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 721658dc-3b1d-43ff-9032-e96851633cf9 | 2024-02-19 | Warnings | M017 |
| Ralli Rapid Pain Relief Roll on | MENTHOL | Troy Manufacturing, Inc. | 978d5c2c-fdc4-4d25-83ec-0b9404ec8018 | 2024-02-19 | Warnings | M017 |
| 1168 | 1168 BURN SPRAY | Dynarex Corporation | 1183a4f5-f875-dfb0-e063-6394a90af35f | 2024-02-16 | Warnings | M017 |
| Pain Relief | BENZOCAINE | Safetec of America, Inc. | de84e598-d047-4fae-b2ed-155a3788bc6f | 2024-02-16 | Warnings | M017 |
| No Mess Hydrocortisone Applicator | HYDROCORTISONE | Walgreen Co. | cfefb517-9099-41c4-8a95-74414ca4032c | 2024-02-16 | Warnings | M017 |
| Analgesic Balm | MENTHOL 10%, METHYL SALICYLATE 15% | Geri-Care Pharmaceuticals, Corp | ab9bf09d-bc8c-6d17-e053-2995a90a6c36 | 2024-02-14 | Warnings | M017 |
| Natures Oil 16% Menthol | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 2fbe23b7-23a3-4f0b-bc08-0205256f5d68 | 2024-02-14 | Warnings | M017 |
| Rugby Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Rugby Laboratories | 4c11876c-57ec-4429-a8c4-fb95baa4074a | 2024-02-13 | Warnings | M017 |
| Itch stopping Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 11368823-d4af-a536-e063-6294a90a7a2e | 2024-02-12 | Warnings | M017 |
| Walgreens Boil Pain Relief | BOIL PAIN RELIEF | Walgreens Company | d11bd769-68d0-4057-bc2a-72719f16011e | 2024-02-12 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11673-392-02 | 11673039202 | 1 TUBE in 1 CARTON (11673-392-02) / 28.4 g in 1 TUBE | 1 tube | 2020-10-19 | 0000-00-00 | No | No | Current |