Hydrocortisone Anti-Itch
- Product NDC
- 52000-022
- 11-digit product format
- 520000022
- Labeler code
- 52000
- Product ID
- 52000-022_a27c1753-a558-4cf9-ba63-992d0c4cfde3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Universal Distribution Center LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-12-09
- Substance
- HYDROCORTISONE
- Active strength
- .01 g/g
- 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 product | product | 52000-022 | I | Inactivated by FDA | 2026-10-27 | ||
| excluded package | package | 52000-022 | 52000-022-37 | I | Inactivated by FDA | 2026-10-27 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52000-022-37 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52000-022-37 | f5e01cc5f278… | a2eaf40c39c3… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 52000-022-37 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 52000-022-37 | 9bebd1f3094a… | 5416666fcb17… |
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 Anti-Itch
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | .01 g/g |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52000-022-37 | 2025-07-29 | C162847 | 48780-1 | 9d75b9cf-ed83-f424-e053-dadaa90a57ce | Hydrocortisone Anti-Itch Cream |
| 52000-022-37 | 2020-12-10 | C162847 | 48780-1 | 9d75b9cf-ed83-f424-e053-dadaa90a57ce | Hydrocortisone Anti-Itch Cream |
| 52000-022-37 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ed83-f424-e053-dadaa90a57ce | Hydrocortisone Anti-Itch Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52000-022-38 | Hydrocortisone Anti-Itch | 14 g in 1 TUBE | CREAM | 14 | 4 | |
| 52000-022-39 | Hydrocortisone Anti-Itch | 1 in 1 BOX | CREAM | 1 | 4 | |
| 52000-022-36 | Hydrocortisone Anti-Itch | 14 g in 1 TUBE | CREAM | 14 | 3 | |
| 52000-022-37 | Hydrocortisone Anti-Itch | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52000-022 | HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241212_d44ee37a-305e-4adc-be42-4928d6771655.zip |
| 52000-022 | HYDROCORTISONE ANTI-ITCH (HYDROCORTISONE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241220_186afb11-06b6-4bfa-e063-6294a90aefc6.zip |
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 |
|---|---|---|---|---|---|---|
| LubeLife Climax Control Delay | BENZOCAINE | CC Wellness LLC | e1a98e6d-0c24-75b8-e053-2a95a90ad136 | 2025-09-09 | Warnings | M017 |
| Blue-Emu Maximum Pain Relief | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | c863351a-951b-4f7c-a9c0-4289d702054a | 2025-09-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 02a65b25-78b2-4e29-9484-40e2228fb384 | 2025-09-09 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | e90df2e5-2ef4-47dd-bd74-be9cea6d9d85 | 2025-09-08 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28 | 2025-09-08 | Warnings | M017 |
| SupreH Arnica Bruise Cream | SUPREH ARNICA REMEDY PLUS BRUISE CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3e41fc0e-54c3-2622-e063-6294a90a13c9 | 2025-09-07 | Warnings | M017 |
| Menthol | MENTHOL | FlexiGo Inc | 3607c326-6db0-a2cd-e063-6394a90a9eb6 | 2025-09-06 | Warnings | M017 |
| TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream | PAIN RELIEF CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e08cc87-2385-0838-e063-6394a90abf9b | 2025-09-05 | Warnings | M017 |
| TIDL CLINICAL CRYOTHERAPY MENTHOL Cream | CLINICAL CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e090b98-1db7-4174-e063-6394a90aa539 | 2025-09-05 | Warnings | M017 |
| ALCEMISTE | LIDOCAINE HCL | Price Team Ventures, LLC | 4383faaa-49cf-47b7-83a6-c2a94b6ff9b5 | 2025-09-05 | Warnings | M017 |
| Lansinoh Pain Relieving | LIDOCAINE HCL | Lansinoh Laboratories Inc | b7cf1fdb-946d-a4e8-e053-2995a90a26a8 | 2025-09-05 | Warnings | M017 |
| Sumifun PLANTAR RELIEF ROLL -ON | 4% LIDOCAINE, 1% MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 3c9ee60b-548a-979f-e063-6394a90a70b0 | 2025-09-03 | Warnings | M017 |
| Meijer Capsaicin Heat Patch | CAPSAICIN | Meijer Distribution | 3c465557-0a4f-fb72-e063-6294a90a1ef2 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC Ventures Corp DBA Cryoderm | dd95c682-8ddf-43e7-a277-2fca6ec744cc | 2025-09-02 | Warnings | M017 |
| Pain Relieving | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 27679d31-a5f3-417b-b0c5-5f6b001ecff9 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 52fff03e-eba2-4604-a71c-2522468f627b | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de210c3a-c24e-cefd-e053-2a95a90a93ff | 2025-09-02 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, CAMPHOR, CAPSAICIN | AHC VENTURES CORP DBA CRY | 799751f3-726a-42de-934e-dbc3cd1cb8b8 | 2025-09-02 | Warnings | M017 |
| Pain Relieving Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | de0c9a73-dbc0-599e-e053-2a95a90a7986 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC VENTURES CORP DBA CRYODERM | 90334420-5f81-4284-9a57-42e134ce362f | 2025-09-02 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 186afb11-06b6-4bfa-e063-6294a90aefc6 | 4 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 186afb11-06b6-4bfa-e063-6294a90aefc6 | 4 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 186afb11-06b6-4bfa-e063-6294a90aefc6 | 4 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 186afb11-06b6-4bfa-e063-6294a90aefc6 | 4 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 186afb11-06b6-4bfa-e063-6294a90aefc6 | 4 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | d44ee37a-305e-4adc-be42-4928d6771655 | 3 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | d44ee37a-305e-4adc-be42-4928d6771655 | 3 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | d44ee37a-305e-4adc-be42-4928d6771655 | 3 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | d44ee37a-305e-4adc-be42-4928d6771655 | 3 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | d44ee37a-305e-4adc-be42-4928d6771655 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52000-022-36 | 52000002236 | 14 g in 1 TUBE | 14 g | Historical | ||||
| 52000-022-37 | 52000002237 | 1 TUBE in 1 BOX (52000-022-37) > 14 g in 1 TUBE (52000-022-36) | 1 tube | 2020-12-09 | 0000-00-00 | No | No | Current |
| 52000-022-38 | 52000002238 | 14 g in 1 TUBE | 14 g | Historical | ||||
| 52000-022-39 | 52000002239 | 1 TUBE in 1 BOX (52000-022-39) / 14 g in 1 TUBE (52000-022-38) | 1 tube | 2020-12-09 | No | No | Current |