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 | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| A Health Itch Relief Gel | ITCH RELIEF GEL | Pharma Nobis, LLC | 4f80c403-c760-31ec-e063-6394a90a61c9 | 2026-04-15 | Warnings | M017 |
| Family Care Antibiotic Pain Relief 0.33oz | ANTIBIOTIC PAIN RELIEF | United Exchange Corp | 4f8405fc-3e38-05d9-e063-6394a90a4cda | 2026-04-15 | Warnings | M017 |
| BiteMD | INSECT BITE RELIEF | Wisconsin Pharmacal Company | 4f860c1e-a638-4923-e063-6294a90ae7e2 | 2026-04-15 | Warnings | M017 |
| LavaDerm AfterSun | MENTHOL | Young Living Essential Oils, LC. | 4fcddcf1-36db-2f1a-e054-00144ff8d46c | 2026-04-15 | Warnings | M017 |
| Arlun Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f8b60f9-03e3-e731-e063-6294a90a3b0a | 2026-04-15 | Warnings | M017 |
| tuiwaro Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f66178c-95d9-8c6a-e063-6294a90a2c09 | 2026-04-14 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Pharma Nobis, LLC | 4f6d9a51-c42e-ca88-e063-6394a90a8659 | 2026-04-14 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Pharma Nobis, LLC | 4f6f5a0b-3bfa-289e-e063-6294a90a94b3 | 2026-04-14 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | 4 Visions LLC | 4f76a8c5-fde6-eee0-e063-6394a90a09f8 | 2026-04-14 | Warnings | M017 |
| Signature Pain Relief Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4f555b8f-5193-e685-e063-6294a90a7ba2 | 2026-04-13 | Warnings | M017 |
| Deep Numbing Cream | MENTHOL | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 7943559b-de10-4214-96dc-f9cbac828f46 | 2026-04-13 | Warnings | M017 |
| Hydrocortisone Cream 1% | HYDROCORTISONE CREAM 1% WITH ALOE | Publix Super Markets Inc. | 3c45a654-7fec-55b3-e063-6294a90a184b | 2026-04-13 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | AMERISOURCE BERGEN | 4f5aea1c-ae51-4e1a-e063-6294a90a6aa1 | 2026-04-13 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 8465b443-abe9-78fb-e053-2a91aa0ac1d8 | 2026-04-13 | Warnings | M017 |
| 4Jointz | MENTHOL | ARP(USA) Pty Ltd | 94a5b5f5-abf7-40b3-9dd7-43e2c22f138e | 2026-04-13 | Warnings | M017 |
| Sumifun Pain Relief Creams | METHYL SALICLATE CAPSAICIN CAMPHOR | Guchutang Biotechnology (Longyan) Co., Ltd | 4f3dd96a-d843-d810-e063-6394a90a188e | 2026-04-12 | Warnings | M017 |
| BonicaEaseX 24 Hour Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co., Ltd. | 17fc0cd1-710d-45e6-9513-d7100e3adb42 | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Colorless Roll-On Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | acf460b4-1b41-4b30-a74a-6c3613119d8e | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | 4d84b4fb-8f55-4b2b-b261-858edb7f3144 | 2026-04-10 | Warnings | M017 |
| HealthWise Pain Relief Gel Patch | CAPSAICIN, MENTHOL | Veridian Healthcare | f5484151-b6da-4f64-867f-87160a4ec2d6 | 2026-04-10 | 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 |