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 |
|---|---|---|---|---|---|---|
| Dr Sabharwals | METHYL SALICYLATE 10% GEL PATCH | Dr. Sabharwal's Wound Care | 4a7790bb-25cb-72b8-e063-6294a90a6b9c | 2026-06-29 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Target Corporation | 36602b7a-99c0-f6a4-e063-6294a90a8758 | 2026-06-29 | Warnings | M017 |
| FIRST SHIELD | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Unishield | f86f7446-b741-9f40-e053-6394a90a4422 | 2026-06-29 | Warnings | M017 |
| MQ Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5560cdab-cee8-f6ec-e063-6294a90ad024 | 2026-06-29 | Warnings | M017 |
| GNP Lidocaine Maximum Strength | LIDOCAINE HCL | AMERISOURCE BERGEN | 9f559c20-c9ac-e480-e053-2a95a90a8fce | 2026-06-29 | Warnings | M017 |
| NUMBING | LIDOCAINE | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 5553385d-c1e6-1242-e063-6394a90aa5a7 | 2026-06-28 | Warnings | M017 |
| MOROVAN | LIDOCAINE | HONG KONG UNORDERED TRADING CO., LIMITED | 550c8d2d-e0d7-1531-e063-6394a90a374d | 2026-06-25 | Warnings | M017 |
| Marie Originals Medicated Outdoor Anti Itch | HYDROCORTISONE SPRAY | Marie's Original Formulas, LLC | 5517ee5f-1c51-cfd6-e063-6294a90af56f | 2026-06-25 | Warnings | M017 |
| Marie Originals Medicated Outdoor Anti Itch | HYDROCORTISONE SPRAY | Marie's Original Formulas LLC | 55188ede-68cd-fcc6-e063-6394a90a5c58 | 2026-06-25 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | NuCare Pharmaceuticals, Inc. | 54f07a23-213f-ca46-e063-6394a90a0034 | 2026-06-24 | Warnings | M017 |
| Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | MENTHOL,PRAMOXINE HYDROCHLORIDE | Rida LLC | b62d09e4-7ced-49a9-8c83-3a8ef580f25a | 2026-06-23 | Warnings | M017 |
| Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | PRAMOXINE HYDROCHLORIDE | Rida LLC | 5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2 | 2026-06-23 | Warnings | M017 |
| Pain Relieving cleansing spary | BENZALKONIUM CHLORIDE AND LIDOCAINE HCI | Trifecta Pharmaceuticals USA, LLC. | 48edbb8d-0c35-91d8-e063-6394a90a71b8 | 2026-06-19 | Warnings | M017 |
| Pain Relief | MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 493ab515-5cda-7b5a-e063-6294a90a295b | 2026-06-19 | Warnings | M017 |
| Tiger Balm Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 011fc383-10bc-44cf-a67c-4be45fef33e0 | 2026-06-19 | Warnings | M017 |
| CVS Health Scalp Relief | SALICYLIC ACID | CVS Health | 8de46015-817c-4cd9-95f8-293424f2a5c4 | 2026-06-19 | Warnings | M017 |
| Careland Kinesiology Dual Action Pain Relieving Tape | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 67e0b3c5-e88e-4c48-a1e8-39f502ac249d | 2026-06-18 | Warnings | M017 |
| Zensa | LIDOCAINE | Alera Skin Care Products Inc. | 549348ec-2eb2-3781-e063-6294a90a2f4a | 2026-06-18 | Warnings | M017 |
| SprayPain Away | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | c603e999-2316-496a-e053-2995a90ab4ed | 2026-06-17 | Warnings | M017 |
| SprayPain Away Lavender | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | 547e2167-ade0-ac7e-e063-6294a90a18ea | 2026-06-17 | 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 |