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 |
|---|---|---|---|---|---|---|
| Burn First Aid | BURN FIRST AID | Dynarex Corporation | 826e08be-dffa-5a27-e053-2a91aa0a8701 | 2024-01-22 | Warnings | M017 |
| Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On | MENTHOL | TARGET CORPORATION | 0f95fc55-8665-9e89-e063-6394a90a7891 | 2024-01-22 | Warnings | M017 |
| CVS Health Lidocaine Pain Relief Plus Menthol | LIDOCAINE, MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 77978069-a1b4-473e-83c9-8320e00eea89 | 2024-01-19 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMPS | CAMPHOR, MENTHOL | KOBAYASHI Healthcare International, Inc. | ba26635d-95d3-4d88-93cc-1fd4fd29fd79 | 2024-01-18 | Warnings | M017 |
| Burn | LIDOCAINE | HART Health | e95ebdac-9789-41c2-97da-2307e4538794 | 2024-01-18 | Warnings | M017 |
| Medi-First Hydrocortisone 1% | HYDROCORTISONE ACETATE | Unifirst First Aid Corporation | bd216f5d-f304-7d8d-e053-2a95a90aa9ce | 2024-01-17 | Warnings | M017 |
| Green Guard Hydrocortisone 1% | HYDROCORTISONE | Unifirst First Aid Corporation | bd348e2a-57b1-3f17-e053-2a95a90a8bdc | 2024-01-17 | Warnings | M017 |
| Pain Relief | LIDOCAINE, MENTHOL | HUMN Pharmaceuticals Inc | 6c96f94a-e724-eab3-e053-2991aa0aab88 | 2024-01-17 | Warnings | M017 |
| CVS Health Lidocaine Pain Relief | LIDOCAINE | Natural Essentials, Inc. | 52e82e70-53b7-4ecb-be39-fe10c94cc444 | 2024-01-17 | Warnings | M017 |
| CVS Health XL Lidocaine Pain Relief | LIDOCAINE | NATURAL ESSENTIALS, INC. | ec16da91-8244-402b-b8d8-84896094ac2c | 2024-01-17 | Warnings | M017 |
| Anti-itch | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Target Corporation | f444b0a6-2ed3-4236-8206-342150290675 | 2024-01-17 | Warnings | M017 |
| Maximum Strength Hydrocortisone Anti-itch | HYDROCORTISONE 1% | Target Corporation | 4ff39cb8-3a20-4fe7-9829-1e882a484668 | 2024-01-17 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | eca272cb-ac8f-982b-e053-2995a90aa8b2 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cfde0-c463-e9b5-e053-2a95a90a1924 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cce4b-c70a-1b2d-e053-2995a90aa4aa | 2024-01-15 | Warnings | M017 |
| Oral Pain Relief Gel | BENZOCAINE 20% | Sled Distribution, LLC | e7391302-831e-14dc-e053-2a95a90ac236 | 2024-01-15 | Warnings | M017 |
| FIRST SHIELD | LIDOCAINE HCI | Ever Ready First Aid | e022bf8f-3dd8-de22-e053-2995a90a219b | 2024-01-15 | Warnings | M017 |
| Flexigen | MENTHOL 1.25% | Derma Care Research Labs, LLC | e9ae2682-59b4-e796-e053-2995a90af921 | 2024-01-15 | Warnings | M017 |
| Vita-P Oral and Nasal | MENTHOL 1% | Beijing HKKY Medical Tech. Co., Ltd. | 537c3843-1c92-41c6-b724-52701bbddeab | 2024-01-13 | Warnings | M017 |
| Caring mill Lidocaine Aloe Gel Burn and Pain Relief | LIDOCAINE HYDROCHLORIDE | FSA Store Inc. | 0ec20c87-1681-dd23-e063-6394a90a291c | 2024-01-12 | 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 |