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… |
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
- 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 |
|---|---|---|---|---|---|---|
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | b505769e-9c46-3cf3-e053-2a95a90a4df9 | 2023-11-17 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | d6523993-d781-cdbc-e053-2a95a90af191 | 2023-11-17 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 4d91baf3-9655-4786-93b8-aa0d93fe0bf9 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMP | MENTHOL | KOBAYASHI Healthcare International, Inc. | 7ef03298-6623-4cf4-b21f-74b2ffc11c6e | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 436e8578-b609-4b45-8f84-0d111140fda6 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL | KOBAYASHI Healthcare International, Inc. | 08dcfa78-7332-4f19-90d7-fdd7d446848a | 2023-11-16 | Warnings | M017 |
| Totally Fun After Sun | LIDOCAINE HCL | MJ Products Association, LLC | 965a2a29-914c-4ad0-b25f-5df3c30da393 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f | 2023-11-15 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | b44beac3-1d20-434f-9a79-4fab1ac68791 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 | 2023-11-15 | Warnings | M017 |
| PURE EASE Joint Muscle lnstant Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | 42bf129c-5c84-4331-b6d0-78e3be71a985 | 2023-11-13 | Warnings | M017 |
| PURE EASE Neur Cream Instant Deep Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | e46a4636-6405-440a-a05a-862c354bab54 | 2023-11-13 | Warnings | M017 |
| Cryomax Cooling | MENTHOL | LIFE WEAR TECHNOLOGIES | 0a0ae5ba-9fac-45f6-e063-6294a90ad555 | 2023-11-13 | Warnings | M017 |
| LBri Super Aloe Stop The Pain | METHYL SALICYLATE, MENTHOL, CAPSAICIN | L'Bris, Pure 'N Natural | 8fb2010c-c34b-4552-858d-a0188ad313ad | 2023-11-11 | Warnings | M017 |
| TOTAL RELIEF | HYDROCORTISONE | DR. MARDER SKINCARE, LLC | 2c05459c-5a2c-45ab-b534-87f966b41681 | 2023-11-11 | Warnings | M017 |
| Human Science Muscle Pain Relief | METHYL SALICYLATE, MENTHOL | Human Science, LLC | 4bccc017-264b-11ce-e054-00144ff8d46c | 2023-11-11 | Warnings | M017 |
| Lidozen | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma, LLC | 55108ffd-d6a8-41de-e054-00144ff88e88 | 2023-11-11 | Warnings | M017 |
| Debbies Down and Dirty Deep Tissue Joint and Muscle | MENTHOL | DD&D Manufacturing Co., Ltd | 531fe834-53e3-305f-e054-00144ff88e88 | 2023-11-11 | Warnings | M017 |
| TerraFreeze Pain Relief | MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE | Beyond Derma, LLC | 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677 | 2023-11-11 | Warnings | M017 |
| GOLD ICE Pain Relief | MENTHOL | Eden's Answers, Inc. | a1356c39-42b9-4bd8-a873-bcd40717058b | 2023-11-11 | 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 |