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 |
|---|---|---|---|---|---|---|
| 5 Elementum Delay Wipes | BENZOCAINE DELAY WIPES | MSVenturesGroup O | 440539b0-612b-3b41-e063-6294a90a1ddd | 2026-02-05 | Warnings | M017 |
| COOLING PAIN RELIEF | MENTHOL, CAMPHOR | CHEMCO CORPORATION | 4a156400-7001-d00d-e063-6294a90aa714 | 2026-02-05 | Warnings | M017 |
| burnrelief | LIDOCAINE HCL | Publix Super Markets, Inc. | 9660f5e1-d39e-4f86-bf96-dff0f3bb729d | 2026-02-05 | Warnings, Adverse reactions | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Publix Super Markets, Inc. | fe442f1e-7045-481a-a501-d629bf568dfb | 2026-02-05 | Warnings, Adverse reactions | M017 |
| Care Lix Pain Relief | SALICYLIC ACID | ACQUIRED B SCALE LLC | 65dffffd-ede1-45e2-aa91-bdd5df2df6a6 | 2026-02-05 | Warnings | M017 |
| 2.5% Menthol PAIN RELIEF | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 8075ba60-772c-4d1a-8584-722bb3e539be | 2026-02-05 | Warnings | M017 |
| 4% Menthol PAIN RELIEF | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 51ce716e-b9f3-4e64-8c8e-17520d40f192 | 2026-02-05 | Warnings | M017 |
| 2.0% LIDOCAINE BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 2b58058a-f350-4029-b039-117caf1c0373 | 2026-02-05 | Warnings | M017 |
| 4% MENTHOL COLD THERAPY | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 7acc7282-ef4f-41ec-b51d-a88dfed79bd7 | 2026-02-05 | Warnings | M017 |
| Cooling Gel | PAIN RELIEF COOLING GEL | NeilMed Pharmaceuticals Inc. | 49fb637b-ecc5-1f9b-e063-6294a90ab41a | 2026-02-04 | Warnings | M017 |
| Medicaine Sting and Bite | BENZOCAINE | Dynarex Corporation | b721607e-e36b-4691-a824-c8f520bd6386 | 2026-02-04 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | CHEMCO CORPORATION | 4a05f02e-e882-2cb2-e063-6394a90ad328 | 2026-02-04 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | CHEMCO CORPORATION | 4a065965-43bd-e0e3-e063-6294a90ad76a | 2026-02-04 | Warnings | M017 |
| Menthol plus Camphor Pain Relief | MENTHOL, CAMPHOR | Veridian Healthcare | 4a0969d3-1f06-3ba7-e063-6294a90a8627 | 2026-02-04 | Warnings | M017 |
| Relief Flex | MENTHOL | Beone Co., Ltd. | 49e6f0ef-78fb-26fe-e063-6294a90a6655 | 2026-02-03 | Warnings | M017 |
| NATURULZ ULTIMATE HEALING | CAPSAICIN | I SHAY COSMETICS INC | 436eac74-d07f-d718-e063-6394a90a8660 | 2026-02-03 | Warnings | M017 |
| TheraCare Muscle and Join Pain Relieving Cream | MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 18f9829e-c5f9-4253-e063-6394a90a70c6 | 2026-02-03 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | CVS PHARMACY, INC | 8b8cdb26-8e8f-4e95-9d83-d685c90afe01 | 2026-02-02 | Warnings | M017 |
| Muscular Balm | CAPSAICIN MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | 888f88fc-dcaf-93e5-e053-2a95a90a20e1 | 2026-02-02 | Warnings | M017 |
| Wang Prom Green Balm by Wang Prom | WANG PROM WANG PROM GREEN BALM BY VENTURE GO LLC | AMBIENCE FAMILY INC | 4a063898-16a4-695a-e063-6394a90adb93 | 2026-02-02 | 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 |