HEALING TREE CALMING ANTI-ITCH
- Product NDC
- 76348-804
- 11-digit product format
- 763480804
- Labeler code
- 76348
- Product ID
- 76348-804_42f25140-568e-2798-e063-6394a90a602f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Renu Laboratories, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-26
- Substance
- HYDROCORTISONE
- Active strength
- .59 mg/59mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 package | package | 76348-804 | 76348-804-06 | D | Discontinued by firm | 2026-10-12 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 76348-804-06 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 76348-804-06 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 76348-804-06 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 76348-804-06 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 76348-804-06 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 76348-804-06 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 76348-804-06 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 76348-804-06 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- HEALING TREE CALMING ANTI-ITCH
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | .59 mg/59mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fc8bcde9-26e8-a35f-e053-6394a90a3300 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-05-14 | HEALING TREE CALMING ANTI-ITCH CREAM |
| 2025-05-14 | HEALING TREE CALMING ANTI-ITCH CREAM |
| 2025-01-30 | HEALING TREE CALMING ANTI-ITCH CREAM |
| 2025-01-30 | HEALING TREE CALMING ANTI-ITCH CREAM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-804-05 | HEALING TREE CALMING ANTI-ITCH | 59 mL in 1 BOTTLE, PLASTIC | CREAM | 59 | 3 | |
| 76348-804-06 | HEALING TREE CALMING ANTI-ITCH | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| NeuroMed FA | BENZOCAINE | Sambria Pharmaceuticals, Inc. | 97345ed4-51c3-4221-852c-2cd563f33317 | 2025-11-12 | Warnings | M017 |
| ZHENG GU SHUI | CAMPHOR, MENTHOL | GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD | 17552943-4f11-42d6-ad41-fbc53f2bbd9a | 2025-11-12 | Warnings, Adverse reactions | M017 |
| NeuroMed FA | BENZOCAINE | Sambria Pharmaceuticals, Inc. | 605fc242-ad31-4aa9-bd86-fba4ddf0d305 | 2025-11-12 | Warnings | M017 |
| CAPZIX | CAPSAICIN | Toprail Chp Llc. | a4555840-cf8f-45d8-90bb-3581102b58a7 | 2025-11-12 | Warnings | M017 |
| Hempvana Cold As Ice Pain Relief | MENTHOL | Telebrands Corp | 95e84bb9-ba2e-5009-e053-2995a90a4362 | 2025-11-12 | Warnings | M017 |
| Lidozall | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | 1eb2dfb2-3ad1-488b-aed9-17220e34a10c | 2025-11-12 | Warnings | M017 |
| Lidozall Plus | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ba3cbb15-f4ed-443e-af43-a758481acb0b | 2025-11-12 | Warnings | M017 |
| Knee Pain Relief Patch | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Shenzhen Finona Information Technology Co., Ltd | 38755738-1a06-fdb4-e063-6294a90aa6eb | 2025-11-12 | Warnings | M017 |
| Recovery Numb | LIDOCAINE 4% | PURKLENZ FORMULATIONS INC. | e95e38e3-f743-4f5c-abdf-99ba6856e6f7 | 2025-11-12 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 434c13c2-52ee-000f-e063-6294a90af7e7 | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 434d5f92-05c2-d884-e063-6394a90ad28c | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434df0be-49ff-aa56-e063-6394a90a3b5a | 2025-11-11 | Warnings | M017 |
| TopCare Pain Relief Maximum Strength | LIDOCAINE HYDROCHLORIDE | TOPCO ASSOCIATES | b0ae3a7c-52d1-4923-bd50-6bb3749006c8 | 2025-11-11 | Warnings | M017 |
| Comfortcaine | LIDOCAINE HCL | QS Key West Aloe, LLC | 831b7c11-e437-4e74-808e-c9c1eb8b82f6 | 2025-11-11 | Warnings | M017 |
| A and E Marathon Delay Serum | DELAY SERUM | Phe Inc | 4355d1d8-44fe-aca1-e063-6294a90a85ff | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayStrawberry | ORAL NUMBING SPRAY STRAWBERRY | Phe Inc | 4355dab1-a293-ded6-e063-6394a90af9b0 | 2025-11-11 | Warnings | M017 |
| A and E Easy Anal Gel | ANAL NUMBING LUBRICANT | Phe Inc | 4355e0f3-65ba-eca6-e063-6394a90ab43c | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayPeppermint | ORAL NUMBING SPRAY MINT | Phe Inc | 4355e0d0-1222-d594-e063-6294a90abb29 | 2025-11-11 | Warnings | M017 |
| DermaNumb Analgesic | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 0ea46890-45c3-4732-bc47-227f7c67daf1 | 2025-11-11 | Warnings | M017 |
| Derma Numb Pain Relief | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 710991ae-8f82-4893-93a7-0ef3f815d132 | 2025-11-11 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 76348-804-05 | 76348080405 | 59 mL in 1 BOTTLE, PLASTIC | 59 ml | Historical |
| 76348-804-06 | 76348080406 | 1 in 1 BOX | Historical |