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
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 |
|---|---|---|---|---|---|---|
| Inknows Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 59eb9c12-9e00-0171-e063-6394a90a8342 | 2026-08-25 | Warnings | M017 |
| Lidomar | LIDOMAR | Oncora Pharma, LLC | 215bfdca-60bf-480b-b02e-902de52fe5e8 | 2026-08-25 | Warnings | M017 |
| HEEL PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c7e13f-b9ea-023a-e063-6294a90a79e0 | 2026-08-24 | Warnings | M017 |
| KNEE PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c8b33a-7d4f-2c6e-e063-6394a90a7929 | 2026-08-24 | Warnings | M017 |
| Bovonte Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5958cc29-c449-56a7-e063-6394a90a960b | 2026-08-24 | Warnings | M017 |
| JELVOXA NECK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a3d60a-26b5-e6a6-e063-6294a90a42bd | 2026-08-22 | Warnings | M017 |
| JELVOXA DMSO | CAMPHOR CAPSAICIN MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a43e2c-d258-34b5-e063-6394a90a09bf | 2026-08-22 | Warnings | M017 |
| Capsaicin 0.035 Percent | CAPSAICIN | Preferred Pharmaceuticals Inc. | 0fabc025-4208-45f5-b3c2-543ae3a2df41 | 2026-08-21 | Warnings | M017 |
| Claravie | HYDROCORTISONE ACETATE | Gentell LLC | 598d224b-d12e-89bf-e063-6394a90a84dc | 2026-08-21 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 3b8c2419-7a78-2731-e054-00144ff8d46c | 2026-08-21 | Warnings | M017 |
| Enokon Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 5976e667-e506-1d11-e063-6394a90a6809 | 2026-08-20 | Warnings | M017 |
| MQUPIN TIGER Patch | TIGER PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5977cbb5-94c7-cb24-e063-6294a90a2e07 | 2026-08-20 | Warnings | M017 |
| MQUPIN Nicotine Patches | NICOTINE PATCHES | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5978258a-549e-50e6-e063-6394a90a3d86 | 2026-08-20 | Warnings | M017 |
| Claravie | CAMPHOR | Gentell LLC | 5978bdab-5359-be9a-e063-6394a90a5a32 | 2026-08-20 | Warnings | M017 |
| Rugby PAIN RELIEF PATCHES | LIDOCAINE | RUGBY LABORATORIES | b34e40c8-a257-46cf-9399-f55df9b4102d | 2026-08-20 | Warnings | M017 |
| MAXIMUM STRENGTH Lidocaine Plus Menthol | LIDOCAINE, MENTHOL | ARMY AND AIR FORCE EXCHANGE SERVICE | 60f72061-d264-424e-b396-5a609076d352 | 2026-08-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 5980c527-6bcb-a846-e063-6294a90a0788 | 2026-08-20 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Amerisource Bergen | 5fb5e5ce-b268-4444-8b63-ea7ea6abf269 | 2026-08-20 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | 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 |