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 | 2026-10-23 | ||
| excluded package | package | 52000-022 | 52000-022-37 | I | Inactivated by FDA | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| TONG FENG DING PAIN RELIEF | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 5ef90782-8201-47d1-b57f-f032d4c9b06a | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 1388ab3a-c26f-427d-898d-0d88411a5fba | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Capsaicin Patch Hot | CAPSAICIN | MADISON ONE ACME INC | f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Lung Choy Shung Pain Relief Liquid | MENTHOL AND CAMPHOR | MADISON ONE ACME INC | 4842c6ec-7823-4f6b-afc4-258fce2c2391 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| 701 DIEDA ZHENGTONG YAOGAO MEDICATED | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | 115041ff-5046-4ca4-b54b-5652037e74bd | 2025-11-10 | Warnings, Adverse reactions | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEF | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | 0f269a41-4b56-4e22-b9cb-17d99bf76a57 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| ZANG HONG HUA PAIN RELIEVING | CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE | MADISON ONE ACME INC | e0a8811c-07cf-4dee-a0e5-13b8af1b27b6 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| NECK AND LUMBAR PAIN RELIEVING BALM | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | d06f0650-a5f6-4bc1-a70b-b0fc16968fa9 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| SHU JIN HUO LUO PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | ccb6740d-3399-4a2b-ae65-15ca557ba83b | 2025-11-10 | Warnings, Adverse reactions | M017 |
| GuruNanda Pain Relief | LIDOCAINE HYDROCHLORIDE | GuruNanda, LLC. | 3ab6a133-8dca-e14e-e063-6394a90a85e7 | 2025-11-10 | Warnings | M017 |
| HUO LUO PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 65581716-5a2c-4ee8-816d-00caed7b95b4 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| JOSEPHS LION PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e | 2025-11-10 | Warnings, Adverse reactions | M017 |
| QIAN LI ZHUI FENG PAIN RELIEVING | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | MADISON ONE ACME INC | 03a4fb7c-2328-409d-99c8-cbcf2b4a451f | 2025-11-10 | Warnings, Adverse reactions | M017 |
| WU YANG BRAND PAIN RELIEVING MEDICATED | MENTHOL AND CAMPHOR | MADISON ONE ACME INC | 05c6b95a-aeb6-4234-97c7-8d77eccb38d8 | 2025-11-10 | Warnings | M017 |
| HEI GUI PAIN RELIEVING | CAMPHOR AND METHYL SALICYLATE | MADISON ONE ACME INC | 4140c404-edab-4923-941d-f74125e943a9 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| E MEI SHAN MEDICATED | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | ddcc814e-fcc4-4232-9ab4-826b8aac35f0 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Overtime | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Physicians Science & Nature Inc. | 25fec070-8587-42d1-ba6f-1a9c150acc98 | 2025-11-10 | Warnings | M017 |
| Dendracin Neurodendraxcin | METHYL SALICYLATE, MENTHOL AND CAPSAICIN | Physicians Science & Nature Inc. | 05742cd5-ece2-4007-bdf0-46b76d23df74 | 2025-11-10 | Warnings | M017 |
| Anal Blu | DESENSITIZER | Novelties by Nasswalk, Inc. | 03b9555b-c3ff-4baa-e063-6394a90afb2c | 2025-11-10 | 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 |