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 |
|---|---|---|---|---|---|---|
| Active Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3a9f9ca0-3d8a-796a-e063-6394a90a790c | 2025-08-01 | Warnings | M017 |
| Active Recovery Pain Relief Stick | CAMPHOR, MENTHOL | Charlottes Web, Inc. | 3aa037c6-6109-b52e-e063-6394a90a215b | 2025-08-01 | Warnings | M017 |
| PM Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3aa08859-809d-de8c-e063-6394a90a8e25 | 2025-08-01 | Warnings | M017 |
| Wish ultra winter ice | MENTHOL | LJ Pharma | b4c5487c-1314-4d63-96df-077e72e7ee95 | 2025-08-01 | Warnings | M017 |
| Rugged Fit Pain Relief Roll On | MENTHOL, METHYL SALICYLATE | SYSTEM4BOOK LLC | 39d68734-981c-14d7-e063-6294a90a4919 | 2025-08-01 | Warnings | M017 |
| ICY FREEZE | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 28fdb049-b297-4358-9447-7d69ba879702 | 2025-08-01 | Warnings | M017 |
| Cortizone 10 Cooling | HYDROCORTISONE | Chattem, Inc. | 14d9fce2-9f54-4204-83cb-161de8a303f0 | 2025-08-01 | Warnings | M017 |
| Bravado Labs Numbing | LIDOCAINE HCL | Prodigy Media Inc | 8c43f5b5-b911-4a7a-b2d1-56a09c54b001 | 2025-07-30 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3721c984-1993-6265-e063-6394a90af23f | 2025-07-29 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3758d625-010f-7441-e063-6394a90a066d | 2025-07-29 | Warnings | M017 |
| Cold Therapy Roll on | COLD THERAPY ROLL ON | Allegiant Health | 36463acb-7c28-416f-a45f-a93f0be5692b | 2025-07-29 | Warnings | M017 |
| ProCure Anti Itch | CAMPHOR 0.5% | Twin Med LLC | 3afe387c-ef42-215d-e063-6394a90a41b5 | 2025-07-28 | Warnings | M017 |
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | M017 |
| SYNC ICE | SYNC RELIEF ICE | iON Pharma, LLC | 38ce98ce-a7bf-8041-e063-6394a90ae730 | 2025-07-28 | Warnings | M017 |
| SYNC PRO | SYNC RELIEF PRO CREAM | iON Pharma, LLC | 3a3e91d6-732b-dca9-e063-6394a90a06d4 | 2025-07-28 | Warnings | M017 |
| Careland Pain Relief | METHYL SALICYLATE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd. | 83f36771-1033-4fd0-a0e6-82c1dcfedeee | 2025-07-28 | Warnings | M017 |
| Rite Aid anti-itch | HYDROCORTISONE | Rite Aid Corporation | 2a232dd1-9071-4c55-a7f7-19d8404b99a6 | 2025-07-28 | Warnings | M017 |
| Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | RITE AID CORPORATION | 05598255-3e7a-46a5-ae7e-dcfcb616d59d | 2025-07-28 | Warnings | M017 |
| Inked Inspired | LIDOCAINE HCL | Prodigy Media Inc | 54fb2860-7e63-4598-953a-170226e613e9 | 2025-07-28 | Warnings | M017 |
| Ujhay Hydrocortisone Ointment. | UJHAY HYDROCORTISONE OINTMENT | Guangdong Quadrant Ecological Technology Co., Ltd. | 3af59276-8e6a-0603-e063-6394a90a1f9b | 2025-07-27 | 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 |