Hydrocortisone
- Product NDC
- 68001-526
- 11-digit product format
- 680010526
- Labeler code
- 68001
- Product ID
- 68001-526_09bb81fa-759d-b1b7-e063-6394a90aa2c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Antipruritic (Anti-Itch)
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- BluePoint Laboratories
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-17
- Substance
- HYDROCORTISONE ACETATE
- Active strength
- 1 g/100g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE ACETATE | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3X7931PO74 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1440184 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d6523993-d781-cdbc-e053-2a95a90af191 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-526-45 | Hydrocortisone | 1 in 1 CARTON | OINTMENT | 1 | 5 | |
| 68001-526-45 | Hydrocortisone | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-526-45 | GM - Gram | 68001-526 | 5f212c50-5729-483a-a489-7c5f507a4d74 | 1 | 2023-04-07 |
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 |
|---|---|---|---|---|---|---|
| Post-Treatment Repair Cream | HYDROCORTISONE | Vi Medical Products Inc. | ab8885a9-0778-28ff-e053-2995a90a2e12 | 2025-06-19 | Warnings | M017 |
| MyDerm | LIDOCAINE | Inspec Solutions LLC. | 82d075d1-c92e-2097-e053-2991aa0ab131 | 2025-06-18 | Warnings | M017 |
| Walgreens Extra Small Lidocaine | LIDOCAINE | Walgreen Co. | dc838e47-d234-4ba5-9449-f645e99be923 | 2025-06-18 | Warnings | M017 |
| CLn Body Moisturizer | COLLOIDAL OAT MOISTURIZER | TopMD Skin Care, Inc. | 2de3d68d-a540-d456-e063-6394a90a4b57 | 2025-06-18 | Warnings | M017 |
| Aloe UP SPF 30 Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Aloe Care International, LLC | 35967b33-bdfb-ee3c-e063-6294a90a75f6 | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Aloe Care International, LLC | 35b9dcfa-05f3-3d7b-e063-6394a90a18f1 | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Mineral | ZINC OXIDE | Aloe International, LLC | 35bc3621-f4e4-42d3-e063-6394a90a7aad | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Kids Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Aloe Care International, LLC | 35cd16b0-bd81-8f68-e063-6294a90a3d8c | 2025-06-18 | Warnings | M017 |
| Aloe Up SPF 50 Kids Mineral | ZINC OXIDE | Aloe International, LLC | 35cd5542-947d-a042-e063-6394a90a13f8 | 2025-06-18 | Warnings | M017 |
| Relieve Your Pain | MENTHOL | Proximity Capital Partners LLC dba Asutra | c12369dd-8305-edaf-e053-2995a90a0d3d | 2025-06-18 | Warnings | M017 |
| Melt Pain Away | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | a95a11d7-a2ae-6654-e053-2a95a90a802c | 2025-06-18 | Warnings | M017 |
| Recovery Roll-On | MENTHOL, CAMPHOR | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | ebc9630f-6d8b-e4f0-e053-2995a90a0b49 | 2025-06-18 | Warnings | M017 |
| ProCure Hydrocortisone 1% | HYDROCORTISONE | Twin Med LLC | 37cdfabc-1fdb-246a-e063-6394a90a008a | 2025-06-17 | Warnings | M017 |
| ProCure Hydrocortisone 1% | HYDROCORTISONE | Twin Med LLC | 37ce6c35-b211-43de-e063-6294a90ab773 | 2025-06-17 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | Sun Pharmaceutical Industries, Inc. | 312ddc8d-100e-cfac-e063-6294a90acd09 | 2025-06-16 | Warnings | M017 |
| Toast Screamin Menthol | MENTHOL | IDEAZ, LLC | 37b48b1a-ef3d-afdc-e063-6294a90a6610 | 2025-06-16 | Warnings | M017 |
| Toast Freezin Cold | MENTHOL, METHYL SALICYLATE | IDEAZ, LLC | 37b4d363-0099-8cd3-e063-6394a90a18d6 | 2025-06-16 | Warnings | M017 |
| Earths Care Anti-Itch | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | DLC Laboratories, Inc. | ba65f58a-d590-498a-b8e7-a3d78935d880 | 2025-06-13 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Stratus Pharmaceuticals Inc | 5eb6574c-2066-4390-befc-8e5d2dd6ede2 | 2025-06-12 | Warnings | M017 |
| CHINESE RED TIGER LIDOCAINE PATCHES | 4% LIDOCAINE, 1%MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 36b9a7a2-5832-4ce5-e063-6294a90aed12 | 2025-06-12 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1440184 | hydrocortisone acetate 1 % Topical Ointment | PSN | d6523993-d781-cdbc-e053-2a95a90af191 | 5 |
| 1440184 | hydrocortisone acetate 0.01 MG/MG Topical Ointment | SCD | d6523993-d781-cdbc-e053-2a95a90af191 | 5 |
| 1440184 | hydrocortisone acetate 1 % Topical Ointment | SY | d6523993-d781-cdbc-e053-2a95a90af191 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68001-526-45 | 68001052645 | 1 TUBE in 1 CARTON (68001-526-45) / 28.4 g in 1 TUBE | 1 tube | 2023-05-17 | 0000-00-00 | No | No | Current |