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 |
|---|---|---|---|---|---|---|
| HealthWise 3x Medicated Pain Relief Patch | CAMPHOR,MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 164d4d62-00c0-e06d-e063-6294a90abd73 | 2024-04-17 | Warnings | M017 |
| TIGER Balm PAIN RELIEVING HYDROGEL | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | ca601b02-e9be-4d8d-a384-c62553302ceb | 2024-04-16 | Warnings | M017 |
| Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 1592a40a-a647-34bd-e063-6394a90a0a10 | 2024-04-08 | Warnings | M017 |
| Menticam | CAMPHOR, MENTHOL, METHYL SALICYLATE | PureTek Corporation | 081837a8-9669-be1f-e063-6394a90a9d20 | 2024-04-05 | Warnings | M017 |
| Pain Relieving Liniment | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 97a0c839-0927-4e54-aee2-ded2016ac4a0 | 2024-04-02 | Warnings | M017 |
| HealthWise Capsaicin Heat Patch | CAPSAICIN | Veridian Healthcare | 150c1f09-8aa7-67ea-e063-6294a90a950a | 2024-04-01 | Warnings | M017 |
| HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent | LIDOCAINE HCI | Veridian Healthcare | 150d3e54-5c8d-19ef-e063-6394a90a70c2 | 2024-04-01 | Warnings | M017 |
| Meijer Pain Relief Cream | LIDOCAINE | Meijer Distribution | 07ecee44-387a-cdce-e063-6294a90ab9c9 | 2024-03-27 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 141aa2a7-8789-1127-e063-6294a90a2d23 | 2024-03-20 | Warnings | M017 |
| Pain Relief Muscle | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | 1dc21c95-b419-4175-85f8-040b73060d37 | 2024-03-20 | Warnings | M017 |
| Pain Relief Roll-On Muscle | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | d94ae654-ce25-4bff-b9bd-24a0e0e8568a | 2024-03-20 | Warnings | M017 |
| Pain Relief Muscle | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | f8bff018-fb4f-47b4-b8f8-4a496aede346 | 2024-03-20 | Warnings | M017 |
| Rugby Arthritis Pain Relieving Topical Analgesic | CAPSAICIN | Rugby Laboratories | 8f1bc075-97ac-4154-8768-0d878104c3ba | 2024-03-14 | Warnings | M017 |
| Rugby Ice Blue External Analgesic | MENTHOL, UNSPECIFIED FORM | Rugby Laboratories | 2b65cb6a-4364-4770-b7b9-5c4637edd01a | 2024-03-14 | Warnings | M017 |
| Leader Cooling Pain Relief Topical Analgesic | MENTHOL, UNSPECIFIED FORM | Cardinal Health, 110 dba LEADER | fd06d17f-4dff-42a9-a84f-904809ceb981 | 2024-03-13 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | EROS GLOBAL | b3495c95-ba4b-9459-e053-2a95a90a710f | 2024-03-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | TRIFECTA PHARMACEUTICALS USA LLC | 1369e70f-7a61-7078-e063-6394a90a9a88 | 2024-03-11 | Warnings | M017 |
| Pain Reliever Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 130665d6-3de8-cb91-e063-6294a90a2083 | 2024-03-06 | Warnings | M017 |
| Dermachange Aid Anti-Itch | DIPHENHYDRAMINE HCL | Private Label Beauty and Wellness | 12ed906c-d028-0ff7-e063-6394a90aaa52 | 2024-03-05 | Warnings | M017 |
| Dermachange Cold Therapy | MENTHOL | Private Label Beauty and Wellness | 12ef7dd8-3da3-9c87-e063-6394a90ac924 | 2024-03-05 | 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 |