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 | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|
| La Vaquita New Regular | METHYL SALICYLATE | Delon Laboratories (1990) Ltd | d62186ac-afbb-443e-98c2-f0d122422a3c | 2026-09-01 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 2026-09-01 | Warnings | M017 |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | M017 |
| Terramed Just Think Comfort Hydrocortisone 1% Cream | HYDROCORTISONE | Rida LLC | 0d2c0c2c-370f-4adb-b0ea-1e218c927f8b | 2026-09-01 | Warnings | M017 |
| Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | HyVee Inc | 53157137-b980-45d2-aa10-8c111c0ec2f4 | 2026-08-31 | Warnings | M017 |
| EAYONYUMT NECK PAIN RELIEF | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a450e68-07a7-a4bb-e063-6294a90a97c9 | 2026-08-30 | Warnings | M017 |
| EAYONYUM BACK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a458280-4f9c-5af6-e063-6394a90acb2e | 2026-08-30 | Warnings | M017 |
| EAYONYUM KNEE PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a45d19f-c753-71eb-e063-6294a90a4805 | 2026-08-30 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin | HYDROCORTISONE | AmerisourceBergen | c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495 | 2026-08-30 | Warnings | M017 |
| Olu Pain Management | LIDOCAINE AND CAMPHOR | HAWAII REPACK, INC. | 31ed3d82-ba12-46b2-b0ec-7e5e019efc10 | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a177987-7c05-f07f-e063-6394a90aa9ba | 2026-08-28 | Warnings | M017 |
| Relieved Pro Wrap | 4% LIDOCAINE PATCH | Transfer Technology | 5a1c6ebf-ad3f-c47b-e063-6294a90aa19a | 2026-08-28 | Warnings | M017 |
| Sinsinpas Arex Pain Relieving Patch, Medium | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 46453ef2-512b-4852-e063-6394a90a8912 | 2026-08-28 | Warnings | M017 |
| Sinsinpas arex patch large | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 47c242da-56cd-bea1-e063-6394a90a41de | 2026-08-28 | Warnings | M017 |
| Eagle Brand Eagle Balm | CAMPHOR, MENTHOL | PT. EAGLE INDO PHARMA | 0ba74dba-ec98-09d7-e063-6394a90a22db | 2026-08-27 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a16c6aa-3ab0-3e46-e063-6294a90a6d8f | 2026-08-27 | Warnings | M017 |
| Lidocaine Patch 4% | LIDOCAINE 4% | Global America Group LLC | 1eec782d-0e56-43d2-b842-da0ae47c5dc9 | 2026-08-26 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd | 0f928b5b-60f5-4a45-a409-c601eb330487 | 2026-08-26 | Warnings | M017 |
| PARCHE CALIENTE | CAPSAICINA AND MENTOL | DW SUPPORT LLC | 59f2708e-295a-ccb3-e063-6394a90ad395 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief | LIDOCAINE | CVS Pharmacy | 4ecbc263-e0d4-18d5-e063-6294a90a72e9 | 2026-08-26 | 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 |