Hydrocortisone
- Product NDC
- 0394-0859
- 11-digit product format
- 003940859
- Labeler code
- 0394
- Product ID
- 0394-0859_4d3f087b-6bc1-f6b1-e063-6394a90a9047
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Mericon Industries
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-12
- Substance
- HYDROCORTISONE
- Active strength
- 1.14 g/114g
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | 1.14 g/114g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 103403 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8f351b04-8f6d-4353-9100-13a8a80d656a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0394-0859-32 | Hydrocortisone | 12 in 1 BOX | LOTION | 12 | 3 | |
| 0394-0859-32 | Hydrocortisone | 114 g in 1 BOTTLE, DISPENSING | LOTION | 114 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0394-0859-32 | GM - Gram | 0394-0859 | e89da67a-d959-4f7e-a459-80731c836520 | 1 | 2023-07-06 |
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 |
|---|---|---|---|---|---|---|
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3758d625-010f-7441-e063-6394a90a066d | 2025-07-29 | Warnings | M017 |
| Cold Therapy Roll on | COLD THERAPY ROLL ON | Allegiant Health | 36463acb-7c28-416f-a45f-a93f0be5692b | 2025-07-29 | Warnings | M017 |
| ProCure Anti Itch | CAMPHOR 0.5% | Twin Med LLC | 3afe387c-ef42-215d-e063-6394a90a41b5 | 2025-07-28 | Warnings | M017 |
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | M017 |
| SYNC ICE | SYNC RELIEF ICE | iON Pharma, LLC | 38ce98ce-a7bf-8041-e063-6394a90ae730 | 2025-07-28 | Warnings | M017 |
| SYNC PRO | SYNC RELIEF PRO CREAM | iON Pharma, LLC | 3a3e91d6-732b-dca9-e063-6394a90a06d4 | 2025-07-28 | Warnings | M017 |
| Careland Pain Relief | METHYL SALICYLATE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd. | 83f36771-1033-4fd0-a0e6-82c1dcfedeee | 2025-07-28 | Warnings | M017 |
| Rite Aid anti-itch | HYDROCORTISONE | Rite Aid Corporation | 2a232dd1-9071-4c55-a7f7-19d8404b99a6 | 2025-07-28 | Warnings | M017 |
| Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | RITE AID CORPORATION | 05598255-3e7a-46a5-ae7e-dcfcb616d59d | 2025-07-28 | Warnings | M017 |
| Inked Inspired | LIDOCAINE HCL | Prodigy Media Inc | 54fb2860-7e63-4598-953a-170226e613e9 | 2025-07-28 | Warnings | M017 |
| Ujhay Hydrocortisone Ointment. | UJHAY HYDROCORTISONE OINTMENT | Guangdong Quadrant Ecological Technology Co., Ltd. | 3af59276-8e6a-0603-e063-6394a90a1f9b | 2025-07-27 | Warnings | M017 |
| SANA SANA Menthol External Analgesic | MENTHOL | Alquimia Najulam S de RL de CV | 8b7edd51-e08a-4e01-9df0-8305ce17b418 | 2025-07-25 | Warnings | M017 |
| Hydrocortisone Intensive Healing Formula | HYDROCORTISONE | TARGET Corporation | 682b737f-e453-4079-bf31-47a9485c7897 | 2025-07-25 | Warnings | M017 |
| Chigg Away | BENZOCAINE | Pierson Laboratories, Inc. | 8372e7c1-f145-4bc5-85ab-cf831abe70ce | 2025-07-24 | Warnings | M017 |
| Chigg Away | BENZOCAINE | Pharma Nobis, LLC | e42fa1c6-d804-630f-e053-2995a90add6b | 2025-07-24 | Warnings | M017 |
| Cannarelief 2000mg | MENTHOL | Earthmed LLC | 01f810de-52ba-8beb-e063-6394a90a61c0 | 2025-07-24 | Warnings | M017 |
| CHING WAN HUNG SOOTHING HERBAL BALM | MENTHOL | TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD. | ffadc904-8e9d-4cb8-815a-d583bbdb3f0b | 2025-07-24 | Warnings | M017 |
| PT Elite Premium Pain Relief | CAPSAICIN, MENTHOL | PT ELITE PRODUCTS LLC | ad251821-4c58-425d-bdcb-8dd9bd41b713 | 2025-07-23 | Warnings | M017 |
| Whipped Butter SPF 50 | ZINC OXIDE | Bloomeffects, Inc | 374b62d8-e012-591f-e063-6294a90aef93 | 2025-07-23 | Warnings | M017 |
| Game On Xtreme | MENTHOL, UNSPECIFIED FORM | Natural Essentials Inc. | 5a1b6192-d537-42b3-add8-22c63e7c986c | 2025-07-23 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103403 | hydrocortisone 1 % Topical Lotion | PSN | 8f351b04-8f6d-4353-9100-13a8a80d656a | 3 |
| 103403 | hydrocortisone 10 MG/ML Topical Lotion | SCD | 8f351b04-8f6d-4353-9100-13a8a80d656a | 3 |
| 103403 | hydrocortisone 1 % Topical Lotion | SY | 8f351b04-8f6d-4353-9100-13a8a80d656a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0394-0859-32 | 00394085932 | 12 BOTTLE, DISPENSING in 1 BOX (0394-0859-32) / 114 g in 1 BOTTLE, DISPENSING | 2023-06-12 | No | No | Current |