Hydrocortisone
- Product NDC
- 37808-319
- 11-digit product format
- 378080319
- Labeler code
- 37808
- Product ID
- 37808-319_194ade5a-3f75-4d50-a6d7-4cdb4b70a241
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- H E B
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-09-11
- 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
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 g/100g |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-319-16 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | 5 | |
| 37808-319-16 | Hydrocortisone | 56 g in 1 TUBE | CREAM | 56 | 5 | |
| 37808-319-64 | Hydrocortisone | 28 g in 1 TUBE | CREAM | 28 | 5 | |
| 37808-319-64 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | HYDROCORTISONE CREAM [H E B] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE CREAM [H E B] | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | HYDROCORTISONE CREAM [H E B] | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | HYDROCORTISONE CREAM [H E B] | 1 | |
| CETYL PALMITATE | INACTIVE INGREDIENT | 5ZA2S6B08X | HYDROCORTISONE CREAM [H E B] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HYDROCORTISONE CREAM [H E B] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | HYDROCORTISONE CREAM [H E B] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE CREAM [H E B] | 1 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | HYDROCORTISONE CREAM [H E B] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE CREAM [H E B] | 1 |
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 |
|---|---|---|---|---|---|---|
| Universal PAIN RELIEF | LIDOCAINE | Universal Distribution Center LLC | b132a4f2-1b1f-4e80-a183-f9add449065f | 2024-10-14 | Warnings | M017 |
| Nervex Pain Relieving | CAPSAICIN | VITA SCIENCES, LLC | a39bba22-8c54-4252-9973-052dd2aaea36 | 2024-10-14 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | NATURAL ESSENTIALS, INC. | d07fdffd-bf7c-4950-9b2d-c06d54ef4c55 | 2024-10-14 | Warnings | M017 |
| Walgreens Cooling | LIDOCAINE HYDROCHLORIDE | WALGREEN COMPANY | baffb272-436c-4ad8-e053-2a95a90a56fb | 2024-10-14 | Warnings | M017 |
| Walgreens Sunburn Relief | MENTHOL | WALGREEN COMPANY | c8967fba-6c28-494b-e053-2995a90acbba | 2024-10-14 | Warnings | M017 |
| Walgreens Sunburn Relief | LIDOCAINE | WALGREEN COMPANY | d5067903-c559-dc6d-e053-2995a90a8ee3 | 2024-10-14 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | Meijer Distribution Inc | 18998e1c-1254-4d0c-93f1-26652c5ca076 | 2024-10-14 | Warnings | M017 |
| signature care itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Safeway | 3eedcd9f-8312-4d14-a0fe-6b00a00d3e73 | 2024-10-13 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | H E B | 34c7bcd3-203f-4630-894d-3739a1576c8d | 2024-10-13 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 25ec9014-64c4-44df-9e67-9f9223ffc923 | 2024-10-12 | Warnings | M017 |
| PAIN RELIEF Gel-Roll On | LIDOCAINE AND MENTHOL | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | f02fa9c0-b8af-f362-e053-2a95a90ae516 | 2024-10-11 | Warnings | M017 |
| Insect Sting Relief Pad | BENZOCAINE, ALCOHOL | Hubei Changjian Medical Products Co., Ltd. | 6a269982-0e25-4c09-aef1-0b398bdc5ed4 | 2024-10-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 24221805-e5c9-5785-e063-6394a90a9d2f | 2024-10-10 | Warnings | M017 |
| De La Cruz Camphor | CAMPHOR | DLC Laboratories, Inc. | 62359237-de2d-4497-bfd6-36991cfc8acf | 2024-10-10 | Warnings | M017 |
| Anti Itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Meijer Distribution Inc | 4f536a86-6419-4ab0-a7e8-5c37943823e2 | 2024-10-09 | Warnings | M017 |
| terrasil Bruise and Pain Relief Maximum Strength | CAMPHOR, MENTHOL | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 240b231d-a8b2-c64c-e063-6394a90a7440 | 2024-10-09 | Warnings | M017 |
| Muscle Freeze Relief | MENTHOL | NATURAL ESSENTIALS, INC. | 815c534b-096d-49f2-b5f2-8c885d45a5e6 | 2024-10-09 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | VIVE HEALTH LLC | 2410dc2f-9332-19fa-e063-6394a90a2835 | 2024-10-09 | Warnings | M017 |
| CVS Health Lidocaine Pain-Relieving | LIDOCAINE | Natural Essentials, Inc. | fc23b2e2-4abc-4119-b8bd-305b4327f1dd | 2024-10-09 | Warnings | M017 |
| KERACARE | MENTHOL 1% | Avlon Industries, Inc. | f72eec6d-1204-4e03-8aed-d5bcf8d3bbce | 2024-10-09 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 15eb4676-5f6e-4c28-b5b9-4e45412dc37a | 5 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 15eb4676-5f6e-4c28-b5b9-4e45412dc37a | 5 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 15eb4676-5f6e-4c28-b5b9-4e45412dc37a | 5 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 15eb4676-5f6e-4c28-b5b9-4e45412dc37a | 5 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 15eb4676-5f6e-4c28-b5b9-4e45412dc37a | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37808-319-16 | 37808031916 | 1 TUBE in 1 CARTON (37808-319-16) / 56 g in 1 TUBE | 1 tube | 2024-10-16 | No | No | Current | |
| 37808-319-64 | 37808031964 | 1 TUBE in 1 CARTON (37808-319-64) / 28 g in 1 TUBE | 1 tube | 2015-09-11 | 0000-00-00 | No | No | Current |