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 |
|---|---|---|---|---|---|---|
| Resinol | PETROLATUM AND RESORCINOL | ResiCal, Inc. | 03f57a4a-f94b-4ba6-b709-41cfb6e16261 | 2025-12-17 | Warnings | M017 |
| HealthWise Maximum Pain Relief | LIDOCAINE | Veridian Healthcare | afc3c16d-0076-44b2-ae7e-5f36d4d8088e | 2025-12-17 | Warnings | M017 |
| HealthWise Max Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | f39a27da-6799-4fc6-97ca-101eac4a9360 | 2025-12-17 | Warnings | M017 |
| HealthWise Original Menthol | MENTHOL | Veridian Healthcare | e4bfb6b0-545e-4fbc-8538-4f41a6be1025 | 2025-12-17 | Warnings | M017 |
| Welly Polka First Aid Kit | HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Dongguan Shenglian Tins Products Co., Ltd. | d7c4314c-c4c6-4adf-b384-3ac7a7108319 | 2025-12-17 | Warnings | M017 |
| Frankincense and Myrrh Arthritis Pain Therapy | MENTHOL | Wise Consumer Products | 2410a199-f4a3-da6c-e063-6394a90aaace | 2025-12-17 | Warnings | M017 |
| Lidocaine | LIDOCAINE, MENTHOL | Vive Health LLC | 462d3b24-643e-91da-e063-6394a90a0e1d | 2025-12-17 | Warnings | M017 |
| Teevodar Pain Relieving | MENTHOL | Sod-e Biotech Ltd | 205b0fef-4f00-db2e-e063-6294a90a93b8 | 2025-12-17 | Warnings | M017 |
| Frankincense and Myrrh Arthritis Pain Relief | MENTHOL | WISE CONSUMER PRODUCTS CO. | 116045df-891b-f370-e063-6294a90abe42 | 2025-12-17 | Warnings | M017 |
| Frankincense and Myrrh Intensive Foot Therapy | MENTHOL | Wise Consumer Products | 23e56c6b-0f2b-721f-e063-6394a90a1ed0 | 2025-12-17 | Warnings | M017 |
| Tiger Balm Ultra Strength | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | f0561804-e0f7-495d-9768-9b86a208c51e | 2025-12-17 | Warnings | M017 |
| Kwan Loong | METHYL SALICYLATE AND MENTHOL | Haw Par Healthcare Ltd. | 54bcb26e-786a-403e-9330-11ae9e3c013a | 2025-12-17 | Warnings | M017 |
| Magsoothium Body Cooling Formula | MENTHOL | Ubu/Elements, Inc. | f7fb6ac9-a920-a440-e053-6394a90aaa35 | 2025-12-16 | Warnings | M017 |
| Magsoothium CBD Body Lavender | MENTHOL | Ubu/Elements, Inc. | f9b87fbe-b889-67a1-e053-6394a90acbcd | 2025-12-16 | Warnings | M017 |
| Aquaphor Itch Relief | HYDROCORTISONE | Beiersdorf Inc | b1d0333f-ba60-35d8-e053-2995a90af932 | 2025-12-16 | Warnings | M017 |
| Magsoothium CBD Body | MENTHOL | Ubu/Elements, Inc. | 00b2ef34-42d7-523c-e063-6294a90a753d | 2025-12-16 | Warnings | M017 |
| GENTLECARE HAND AND SKIN SANITIZER | BENZALKONIUM CHLORIDE | PARAGON SOLUTIONS US, INC. | 16650277-fa62-485e-9a82-7763d2b50168 | 2025-12-16 | Warnings | M017 |
| Welly First Aid Kit Refill | HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE | Dongguan Shenglian Tins Products Co., Ltd. | 4bc93855-4009-4b49-9fb4-e5864054153d | 2025-12-16 | Warnings | M017 |
| LidocainePain pain reliving gel-patch | PAIN RELIVING GEL-PATCH | Shenzhen Yuetai Electronic Commerce Co., Ltd | 461ebbdd-0f26-a333-e063-6394a90a7a3e | 2025-12-16 | Warnings | M017 |
| Zestama | CAPSAICIN | V2 Pharma LLC | c9b46759-b8df-4ff4-815e-8e032c2635c0 | 2025-12-15 | 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 |