hydrocortisone
- Product NDC
- 45802-438
- 11-digit product format
- 458020438
- Labeler code
- 45802
- Product ID
- 45802-438_adca01b2-b9fa-4785-be0e-1bd493446cc7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-05-06
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 45802-438 | 45802-438-05 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 45802-438 | 45802-438-70 | D | Discontinued by firm | 2026-10-12 |
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… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
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 |
|---|---|
| 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-438-03 | hydrocortisone | 28 g in 1 TUBE | CREAM | 28 | 9 | |
| 45802-438-03 | hydrocortisone | 1 in 1 CARTON | CREAM | 1 | 9 | |
| 45802-438-05 | hydrocortisone | 454 g in 1 JAR | CREAM | 454 | 9 | |
| 45802-438-70 | hydrocortisone | 144 in 1 CARTON | CREAM | 144 | 9 | |
| 45802-438-70 | hydrocortisone | .9 g in 1 PACKET | CREAM | .9 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-438-03 | GM - Gram | 45802-438 | 3634198b-3abd-46dd-9e1a-f43c8f37ad45 | 1 | 2012-07-24 |
| 45802-438-05 | GM - Gram | 45802-438 | e7af108f-440a-4ff7-94c2-15cb34cf5cea | 1 | 2012-07-24 |
| 45802-438-70 | EA - Each | 45802-438 | 3d62d85d-e8af-4abb-8dee-b614f448fd9e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| BLT 2 | LIDOCAINE HCL | CENTURA PHARMACEUTICALS INC | 41dc85ec-d79b-0a32-e054-00144ff8d46c | 2026-01-12 | Warnings | M017 |
| Mineral Ice Pain Relieving | MENTHOL | Crown Laboratories | 7b30076a-0af6-2f74-e053-2a91aa0ae08d | 2026-01-12 | Warnings | M017 |
| Sarna | PRAMOXINE HYDROCHLORIDE | Crown Laboratories | 19b0ce1b-e147-01a1-e063-6394a90af808 | 2026-01-12 | Warnings | M017 |
| Sarna | PRAMOXINE HYDROCHLORIDE, MENTHOL | Crown Laboratories, Inc | 19c41e75-a654-90cf-e063-6394a90a7e97 | 2026-01-12 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | HY-VEE, INC | 48350b54-8d9a-48c4-e063-6394a90ac040 | 2026-01-12 | Warnings | M017 |
| LidoPlus Pain Relief | LIDOCAINE HYDROCHLORIDE | Centura Pharmaceuticals, Inc | 07bacc6c-60a6-4297-8663-904a22bdc040 | 2026-01-12 | Warnings | M017 |
| BlueStop Max | EXTERNAL ANALGESIC | Clavel Corporation | f1efb51c-5217-4cb2-e053-2a95a90a7f95 | 2026-01-12 | Warnings | M017 |
| BlueStop Max | EXTERNAL ANALGESIC | Clavel Corporation | f2277e27-868b-57ef-e053-2a95a90abf28 | 2026-01-12 | Warnings | M017 |
| BLT 3 | TETRACAINE | CENTURA PHARMACEUTICALS INC | 401a0d22-1181-02ac-e054-00144ff88e88 | 2026-01-12 | Warnings | M017 |
| Sting Relief Prep Pad | BENZOCAINE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 0c901f64-6890-45c0-9ca7-ee9de87903c4 | 2026-01-12 | Warnings | M017 |
| Goodsense Oral Pain Relief | BENZOCAINE | Geiss, Destin and Dunn, Inc. | eb461b70-d10f-4e11-8374-e43713f3504d | 2026-01-12 | Warnings | M017 |
| Extra Strength Balm | CAPSICUM AND MENTHOL | Saje Natural Business Inc | f516e416-446b-8f21-e053-2a95a90afd88 | 2026-01-12 | Warnings | M017 |
| Pain Release | MENTHOL | Saje Natural Business Inc. | 3df0e56a-7651-42dc-8ed8-f68836a63c61 | 2026-01-12 | Warnings | M017 |
| Trauma Less | MENTHOL | Saje Natural Business Inc. | 650cba4c-6aba-48c3-9c41-841f19905548 | 2026-01-12 | Warnings | M017 |
| Mamisan | LIDOCAINE HYDROCHLORIDE, MENTHOL | Miramar Cosmetics, Inc DBA Miramar Lab | 4402e900-c6e9-4f32-8cc4-c84014384a9f | 2026-01-12 | Warnings | M017 |
| Curist Lidocaine Patch | LIDOCAINE 4% PATCH | Little Pharma, Inc. | 1a8fe44e-7a21-c2ab-e063-6394a90a6100 | 2026-01-11 | Warnings | M017 |
| DG Health Pain Relieving | LIDOCAINE HCL | DOLGENCORP, LLC | 923aeb4c-049f-4ecc-a77e-9ffa0e236d4e | 2026-01-11 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare | 46b84e0b-78a9-4cde-9f90-e165b5419162 | 2026-01-09 | Warnings | M017 |
| MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On | MENTHOL | Inspec Solutions | 12ff9b9a-73e5-ce31-e063-6294a90aeaf8 | 2026-01-09 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | bb0278c9-eaff-d435-e053-2995a90a202a | 2026-01-09 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 9 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 9 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 9 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 9 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 9 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 12cd35e3-e707-4551-b778-bf615c1a8d32 | 6 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 6 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 12cd35e3-e707-4551-b778-bf615c1a8d32 | 6 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 6 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 6 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 12cd35e3-e707-4551-b778-bf615c1a8d32 | 6 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 6 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 12cd35e3-e707-4551-b778-bf615c1a8d32 | 6 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 6 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 12cd35e3-e707-4551-b778-bf615c1a8d32 | 6 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | b6734f71-dcbc-49ac-9c13-455ed624d08f | 5 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | b6734f71-dcbc-49ac-9c13-455ed624d08f | 5 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | b6734f71-dcbc-49ac-9c13-455ed624d08f | 5 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | b6734f71-dcbc-49ac-9c13-455ed624d08f | 5 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | b6734f71-dcbc-49ac-9c13-455ed624d08f | 5 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 96a2d2c6-cc01-4df3-a572-fff39334d91e | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 9c0feade-bb3f-4251-b8ae-aee4f548238f | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 20b3934b-edc4-40b8-b5fa-17259a200c5d | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 96a2d2c6-cc01-4df3-a572-fff39334d91e | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 9c0feade-bb3f-4251-b8ae-aee4f548238f | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 20b3934b-edc4-40b8-b5fa-17259a200c5d | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 96a2d2c6-cc01-4df3-a572-fff39334d91e | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 9c0feade-bb3f-4251-b8ae-aee4f548238f | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 20b3934b-edc4-40b8-b5fa-17259a200c5d | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 9c0feade-bb3f-4251-b8ae-aee4f548238f | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 96a2d2c6-cc01-4df3-a572-fff39334d91e | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 20b3934b-edc4-40b8-b5fa-17259a200c5d | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 9c0feade-bb3f-4251-b8ae-aee4f548238f | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 96a2d2c6-cc01-4df3-a572-fff39334d91e | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 20b3934b-edc4-40b8-b5fa-17259a200c5d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45802-438-03 | 45802043803 | 1 TUBE in 1 CARTON (45802-438-03) / 28 g in 1 TUBE | 1 tube | 2011-05-06 | 0000-00-00 | No | No | Current |
| 45802-438-05 | 45802043805 | 1 JAR in 1 CARTON (45802-438-05) > 454 g in 1 JAR | 1 jar | 2011-05-10 | 0000-00-00 | No | No | Current |
| 45802-438-70 | 45802043870 | 144 in 1 CARTON | Historical |