FixMySkin Healing Balm Fragrance-Free
- Product NDC
- 76314-002
- 11-digit product format
- 763140002
- Labeler code
- 76314
- Product ID
- 76314-002_2a934860-029e-a463-e063-6294a90aa446
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- HYDROCORTISONE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Lovely Skin, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-12-31
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/mL
- 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 | 76314-002 | 76314-002-02 | D | Discontinued by firm | 2026-10-21 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- FixMySkin Healing Balm Fragrance-Free
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 203105 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c12af4c6-2f05-46ec-b901-1a4fcd750180 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76314-002-02 | FixMySkin Healing Balm Fragrance-Free | 7.39 mL in 1 PACKAGE | OINTMENT | 7.39 | 12 | |
| 76314-002-03 | FixMySkin Healing Balm Fragrance-Free | 14.78 mL in 1 PACKAGE | OINTMENT | 14.78 | 12 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| 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 | |
| Genuine First Aid Alcohol Cleansing Pad | BENZOCAINE, ALCOHOL | GFA Production (Xiamen) Co., Ltd. | c39c4d80-9718-459f-8ae4-ada043bba5b7 | 2024-06-26 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 1bd5cf69-9a08-5e2e-e063-6394a90a03cd | 2024-06-26 | Warnings | M017 |
| Solarcaine Burn Pain Relief 4oz | SOLARCAINE BURN PAIN RELIEF 4OZ | WellSpring Pharmaceutical Corporation | 2c0389db-ceb2-422b-9575-bdb8fe649a1e | 2024-06-26 | Warnings | M017 |
| astonea | HYDROCORTISONE | ASTONEA LABS PRIVATE LIMITED | de09e859-c5fd-0cc5-e053-2a95a90a147e | 2024-06-25 | Warnings | M017 |
| HealthWise Pain Relief Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 0190196d-5f78-042b-e063-6294a90a3714 | 2024-06-25 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 1bc1bf83-91ee-ec9d-e063-6394a90a3daf | 2024-06-25 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 203105 | hydrocortisone 1 % Topical Ointment | PSN | c12af4c6-2f05-46ec-b901-1a4fcd750180 | 12 |
| 203105 | hydrocortisone 0.01 MG/MG Topical Ointment | SCD | c12af4c6-2f05-46ec-b901-1a4fcd750180 | 12 |
| 203105 | hydrocortisone 1 % Topical Ointment | SY | c12af4c6-2f05-46ec-b901-1a4fcd750180 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76314-002-02 | 76314000202 | 7.39 mL in 1 PACKAGE (76314-002-02) | 7.39 ml | 2011-11-17 | 0000-00-00 | No | No | Current |
| 76314-002-03 | 76314000203 | 14.78 mL in 1 PACKAGE (76314-002-03) | 14.78 ml | 2011-11-17 | 0000-00-00 | No | No | Current |