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 |
|---|---|---|---|---|---|---|
| ElixirLidoFast | LIDOCAINE 5% CREAM | ELIXIR HEALTHCARE USA, LLC. | 45de5a3d-06c2-aa02-e063-6294a90a63d3 | 2025-12-13 | Warnings | M017 |
| MEDI FIRST PLUS | HYDROCORTISONE ACETATE | Orazen Inc | 5781124a-60f4-4a64-80b7-ce5f28d495b5 | 2025-12-12 | Warnings | M017 |
| MEDI-FIRST | HYDROCORTISONE ACETATE | Orazen Inc | aeffd85c-58a7-4d64-bf94-977b6fbbe713 | 2025-12-12 | Warnings | M017 |
| Joint and Muscle Relief | MENTHOL | Smart Cookie Solutions Inc. | 45c24d56-4dc9-2884-e063-6294a90a52cc | 2025-12-12 | Warnings | M017 |
| Popstar | DELAY SPRAY | Pineapple Brands LLC | 293b2da9-1261-0358-e063-6394a90aa08c | 2025-12-12 | Warnings | M017 |
| Careland Pain Relief Plus | CAMPHOR, MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | d9e63ddd-d003-45fa-b156-7f4452c28cbd | 2025-12-12 | Warnings | M017 |
| Glucosamine Cream EXTRA STRENGTH | HISTAMINE DIHYDROCHLORIDE | IDEAZ, LLC | f4d414b7-89e7-ad65-e053-2a95a90a25d4 | 2025-12-12 | Warnings | M017 |
| ARTHRITIS | MENTHOL | Smith Amish, LLC | 20c36972-b695-1241-e063-6394a90adf63 | 2025-12-12 | Warnings | M017 |
| FOOT | MENTHOL | Smith Amish, LLC | 20c48537-f55f-c10f-e063-6394a90a4cca | 2025-12-12 | Warnings | M017 |
| Joint Ease | MENTHOL | Smith Amish, LLC | 20c4a0f8-bdc6-d89a-e063-6294a90aa8d8 | 2025-12-12 | Warnings | M017 |
| Toast Screamin Hot | CAPSAICIN | IDEAZ, LLC | 331207e6-b8ac-b169-e063-6394a90ac169 | 2025-12-12 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE | KORVIA GLOBAL Inc. | 45ccfcae-a307-1c5f-e063-6294a90acf89 | 2025-12-12 | Warnings | M017 |
| Lidospot patch | LIDOCAINE AND MENTHOL | Fabrication Enterprises Inc | 3a6e94c4-1ca6-e77a-e063-6394a90a4bfc | 2025-12-12 | Warnings | M017 |
| LETEBEE LIGHT neuropathy pain relief cream for feet | MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 45a99afc-15ec-76c2-e063-6294a90a2220 | 2025-12-11 | Warnings | M017 |
| Cinthera | LIDOCAINE | Strand Health Group | 2746e5b2-be2d-f2d2-e063-6394a90a3690 | 2025-12-11 | Warnings | M017 |
| Equate Cool and Heat Pain Relieving Liquid | COOL AND HEAT PAIN RELIEF | Walmart, Inc. | ad156685-3bd5-6837-e053-2995a90ac788 | 2025-12-11 | Warnings | M017 |
| HUMCO Camphor Spirit | CAMPHOR 10% | Humco Holding Group, Inc. | 9a0ef0a3-3c79-41b2-8193-424a3ef9886f | 2025-12-11 | Warnings | M017 |
| T-Relief Lidocaine HCL 4% | LIDOCAINE HCL 4% | Medinatura New Mexico Inc. | 3c19aff8-fb18-78d0-e063-6294a90a9481 | 2025-12-11 | Warnings | M017 |
| Jointiva | TROLAMINE SALICYLATE 10% | Rising Pharma Holdings, Inc. | 3ee33cbf-7c0f-4982-b0b6-eeeb0202803b | 2025-12-11 | Warnings | M017 |
| LMX4 | LIDOCAINE | Ferndale Laboratories, Inc. | f0e7c92f-8b0b-4045-b659-af9f6e81260f | 2025-12-10 | 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 |