UniShield First Aid Burn
- Product NDC
- 49314-0002
- 11-digit product format
- 493140002
- Labeler code
- 49314
- Product ID
- 49314-0002_3fe7d22c-5cf8-f629-e063-6294a90a021e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine HCL
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Unishield
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-03-20
- Substance
- LIDOCAINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49314-0002-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49314-0002-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49314-0002-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49314-0002-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49314-0002-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49314-0002-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49314-0002-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49314-0002-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UniShield First Aid Burn
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V13007Z41A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1010769 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f729c557-da4b-3fb5-e053-6394a90a4196 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49314-0002-1 | 2025-09-28 | C162847 | 48780-1 | 2cef2736-80ae-d83d-e063-dadaa90ab31f | 49314-0002-1 Unishield First Aid Burn Spray |
| 49314-0002-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-80ae-d83d-e063-dadaa90ab31f | 49314-0002-1 Unishield First Aid Burn Spray |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49314-0002-1 | UniShield First Aid Burn | 59.1 mL in 1 BOTTLE, SPRAY | SPRAY | 59.1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49314-0002 | UNISHIELD FIRST AID BURN (LIDOCAINE HCL) SPRAY [UNISHIELD] | 1 | Current NDC, 1 package rows | 20230320_f729c557-da4b-3fb5-e053-6394a90a4196.zip |
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 |
|---|---|---|---|---|---|---|
| Inknows Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 59eb9c12-9e00-0171-e063-6394a90a8342 | 2026-08-25 | Warnings | M017 |
| Lidomar | LIDOMAR | Oncora Pharma, LLC | 215bfdca-60bf-480b-b02e-902de52fe5e8 | 2026-08-25 | Warnings | M017 |
| HEEL PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c7e13f-b9ea-023a-e063-6294a90a79e0 | 2026-08-24 | Warnings | M017 |
| KNEE PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c8b33a-7d4f-2c6e-e063-6394a90a7929 | 2026-08-24 | Warnings | M017 |
| Bovonte Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5958cc29-c449-56a7-e063-6394a90a960b | 2026-08-24 | Warnings | M017 |
| JELVOXA NECK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a3d60a-26b5-e6a6-e063-6294a90a42bd | 2026-08-22 | Warnings | M017 |
| JELVOXA DMSO | CAMPHOR CAPSAICIN MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a43e2c-d258-34b5-e063-6394a90a09bf | 2026-08-22 | Warnings | M017 |
| Capsaicin 0.035 Percent | CAPSAICIN | Preferred Pharmaceuticals Inc. | 0fabc025-4208-45f5-b3c2-543ae3a2df41 | 2026-08-21 | Warnings | M017 |
| Claravie | HYDROCORTISONE ACETATE | Gentell LLC | 598d224b-d12e-89bf-e063-6394a90a84dc | 2026-08-21 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 3b8c2419-7a78-2731-e054-00144ff8d46c | 2026-08-21 | Warnings | M017 |
| Enokon Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 5976e667-e506-1d11-e063-6394a90a6809 | 2026-08-20 | Warnings | M017 |
| MQUPIN TIGER Patch | TIGER PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5977cbb5-94c7-cb24-e063-6294a90a2e07 | 2026-08-20 | Warnings | M017 |
| MQUPIN Nicotine Patches | NICOTINE PATCHES | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5978258a-549e-50e6-e063-6394a90a3d86 | 2026-08-20 | Warnings | M017 |
| Claravie | CAMPHOR | Gentell LLC | 5978bdab-5359-be9a-e063-6394a90a5a32 | 2026-08-20 | Warnings | M017 |
| Rugby PAIN RELIEF PATCHES | LIDOCAINE | RUGBY LABORATORIES | b34e40c8-a257-46cf-9399-f55df9b4102d | 2026-08-20 | Warnings | M017 |
| MAXIMUM STRENGTH Lidocaine Plus Menthol | LIDOCAINE, MENTHOL | ARMY AND AIR FORCE EXCHANGE SERVICE | 60f72061-d264-424e-b396-5a609076d352 | 2026-08-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 5980c527-6bcb-a846-e063-6294a90a0788 | 2026-08-20 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Amerisource Bergen | 5fb5e5ce-b268-4444-8b63-ea7ea6abf269 | 2026-08-20 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1010769 | lidocaine HCl 2 % Topical Spray | PSN | f729c557-da4b-3fb5-e053-6394a90a4196 | 2 |
| 1010769 | lidocaine hydrochloride 20 MG/ML Topical Spray | SCD | f729c557-da4b-3fb5-e053-6394a90a4196 | 2 |
| 1010769 | lidocaine hydrochloride 2 % Topical Spray | SY | f729c557-da4b-3fb5-e053-6394a90a4196 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49314-0002-1 | 49314000201 | 59.1 mL in 1 BOTTLE, SPRAY (49314-0002-1) | 59.1 ml | 2023-03-20 | No | No | Current |