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 | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Ling Nam Hung Far | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | b6916b6e-b7eb-1eb7-e053-2995a90ae6fb | 2024-07-18 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Bionpharma Inc. | 178ed513-4f22-8f11-e063-6294a90a109b | 2024-07-16 | Warnings | M017 |
| POWERECT Benzocaine Male Delay Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 2fafe1f2-a31e-4b2a-bc51-81e16b319c3a | 2024-07-16 | Warnings | M017 |
| SKINS DELAY Climax Control Benzocaine Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 53730576-2609-4f28-8bfa-a1ceea698b83 | 2024-07-16 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray. | PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a0346-3b00-4803-e063-6294a90aec6d | 2024-07-13 | Warnings | M017 |
| Tidl Pain Relief Evening Therapy Spray. | PAIN RELIEF EVENING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a2f4a-7b25-e595-e063-6394a90a00d5 | 2024-07-13 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY ROLL-ON | PAIN RELIEF HEAT THERAPY ROLL-ON | Shenzhen Sam Technology Co., Ltd. | 1d0b7b8f-9e5d-00f7-e063-6394a90af87c | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY original formula Spray. | PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0b94ec-f956-dff2-e063-6294a90aca4a | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray. | PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0bf4f9-6b02-6cec-e063-6294a90a36c7 | 2024-07-12 | Warnings | M017 |
| Burn Relief | LIDOCAINE HCI 2.0% | Trifecta Pharmaceuticals USA, LLC. | e5e524cd-bb22-715f-e053-2995a90ab5d3 | 2024-07-12 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 1d10e3ca-dc93-8e1a-e063-6394a90a47c0 | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY Spray. | PAIN RELIEF HEAT THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d199826-1b27-b6e7-e063-6394a90a69ad | 2024-07-12 | Warnings | M017 |
| Tidl Pain Relief Morning Therapy Spray. | PAIN RELIEF MORNING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d19d070-3818-73de-e063-6394a90a8958 | 2024-07-12 | Warnings | M017 |
| Hydrocortisone with aloe | HYDROCORTISONE WITH ALOE ANTI ITCH | NeilMed Pharmaceuticals Inc. | 032b9f58-5f64-04dd-e063-6294a90a6bb9 | 2024-07-10 | Warnings | M017 |
| Octagon Pain Relief | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 9926f733-1506-4224-9d70-b1813cd81ec3 | 2024-07-08 | Warnings | M017 |
| LidoReal Patch | LIDOCAINE AND MENTHOL | FORREAL PHARMACEUTICALS LLC | 19f1c037-b4b8-47b0-b0f9-036691c1d307 | 2024-07-05 | Warnings | M017 |
| Lip Medex Lip Balm | PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL | Blistex Inc. | 988f97e8-a59f-4bc0-9d71-60607364a686 | 2024-07-01 | Warnings | M017 |
| Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM | MENTHOL | L'Oreal USA Products Inc | d580982f-dda6-4b03-bf84-342b9f2c6d93 | 2024-06-29 | Warnings | M017 |
| Lip Medex Cherry | PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8 | 2024-06-28 | Warnings | M017 |
| 10% Methyl Salicylate Pain Relief Patch | 10% METHYL SALICYLATE | Akron Coating & Adhesives | 1be1f1ce-3238-a8ed-e063-6294a90a5aed | 2024-06-27 | 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 |