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 | 2026-10-12 |
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 | 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 |
|---|---|---|---|---|---|---|
| Mineral Ice Extreme Dry Stick | MENTHOL | Carlin Consumer Health LLC | 4f81be91-92e5-1205-e063-6394a90a6e82 | 2026-06-02 | Warnings | M017 |
| Kalaya Extra Strength Pain Relief Gel with Arnica | METHYL SALICYLATE, MENTHOL, CAMPHOR | Avaria Health & Beauty Corp | b6a6237d-b471-4102-b5df-fc389f5f9258 | 2026-06-02 | Warnings | M017 |
| Biofreeze Ultraflex | LIDOCAINE | Reckitt Benckiser LLC | 2655974b-a67d-9f07-e063-6294a90a54e8 | 2026-06-02 | Warnings | M017 |
| Biofreeze Ultraflex Plus | LIDOCAINE, MENTHOL | Reckitt Benckiser LLC | 401e1843-e9a6-fda9-e063-6294a90a3073 | 2026-06-02 | Warnings | M017 |
| Pain Relief | MENTHOL SPRAY | Owell Naturals Brand, LLC | 534c871c-da35-6135-e063-6294a90aa9f6 | 2026-06-02 | Warnings | M017 |
| Charm Tex FLUORIDE Gel | SODIUM FLUORIDE | Jiangsu Gold Worldworks Household Chemicals Co., Ltd. | 09d47bd7-1438-4ef2-85e0-9cd5eb2f763a | 2026-05-31 | Warnings | M017 |
| Charm Tex FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Jiangsu Gold Worldworks Household Chemicals Co., Ltd. | 2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f | 2026-05-31 | Warnings | M017 |
| Sting Relief Prep Pad | BENZOCAINE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 9487d15d-9116-4ff8-a004-ba0835ea091e | 2026-05-31 | Warnings | M017 |
| Careland Kinesiology Pain Relieving Tape | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | 35d24cfc-9d34-4fd7-9312-1673b092a3b9 | 2026-05-31 | Warnings | M017 |
| Walgreens Scalp Itch Relief | HYDROCORTISONE | Walgreens | 34952272-1f9e-c642-e063-6394a90ae2bd | 2026-05-29 | Warnings | M017 |
| Aspercreme with Lidocaine No-Mess Applicator | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | 8092cde7-28d0-4755-b5c0-5765934e572f | 2026-05-29 | Warnings | M017 |
| Belladona and Arnica | MENTHOL | Dannso Corp./d.b.a. Essential Products | fc4e63e4-cebc-49ff-8900-7238261d0fe0 | 2026-05-28 | Warnings | M017 |
| Insect Sting Relief | BENZOCAINE, ALCOHOL | Hubei Fanjian Medical Product Co.,Ltd | f30401c1-961e-44dd-e053-2a95a90a69d6 | 2026-05-28 | Warnings | M017 |
| Menthol plus Camphor Pain Relief | MENTHOL, CAMPHOR | Veridian Healthcare | 4a054949-0889-7182-e063-6394a90aff5e | 2026-05-28 | Warnings | M017 |
| Antibacterial Lidocaine Wound Gel | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CVS Pharmacy | 960bfe55-87f6-3e51-e053-2995a90a867d | 2026-05-27 | Warnings | M017 |
| MyDerm Medical 5 Lidocaine Numbing Roll-On | LIDOCAINE | Inspec Solutions | 1d466be1-a780-462f-8dd4-87478da096aa | 2026-05-27 | Warnings | M017 |
| myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol | MENTHOL | Inspec Solutions LLC. | d427d623-c2fd-7d6b-e053-2995a90abdc3 | 2026-05-27 | Warnings | M017 |
| Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Amerisource Bergen | d8802e56-649e-4494-86ee-7ca8841cc28b | 2026-05-27 | Warnings | M017 |
| Equate Itch Relief Gel | ITCH RELIEF GEL | Walmart, Inc | 7d7bb750-017e-c60e-e053-2991aa0ad671 | 2026-05-26 | Warnings | M017 |
| MyDerm Bite and Sting | BENZOCAINE | Medline Industries | bf45c4dd-5814-4602-b96b-f82a44948763 | 2026-05-26 | 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 |