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 |
|---|---|---|---|---|---|---|
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | ASCLEMED USA INC. | 68dc0231-3364-448b-bde9-f19fa122c765 | 2026-05-05 | Warnings | M017 |
| Lidocaine 4% Patch | LIDOCAINE 4% | SOLA Pharmaceuticals | c31957dd-edea-ce98-e053-2a95a90a9c2d | 2026-05-05 | Warnings | M017 |
| Biofreeze Triple Target Gel | CAMPHOR, CAPSAICIN, MENTHOL | Reckitt Benckiser LLC | 511852c8-7428-3234-e063-6394a90a5bc2 | 2026-05-05 | Warnings | M017 |
| 5Kind DMSO Pain Relieving | CAMPHOR (SYNTHETIC) | 5Kind Trading LTD | 62b55114-47f4-473a-8406-78238c3c1fa2 | 2026-05-04 | Warnings | M017 |
| Zinc Oxide with Menthol and White Petrolatum | MENTHOL, ZINC OXIDE, WHITE PETROLATUM | Aldermed Inc. | f993fc0a-bd80-4345-a948-65ac03f910e2 | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | EVERLIT GLOBAL INC. | d7ec5720-4d1f-4943-ae36-c7d6acbae7d7 | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 5371dae4-ea63-46cc-ac26-5418f359c63e | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a2cf1726-3dc9-4624-b898-ac91fb4cbdb2 | 2026-05-04 | Warnings | M017 |
| FIRSTAR BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 186343c5-2e71-49c4-8d64-5fb3131239fa | 2026-05-04 | Warnings | M017 |
| Feminine Anti Itch Cream | BENZOCAINE,RESORCINOL | TRIFECTA PHARMACEUTICALS USA LLC | 50c3acbf-b873-908a-e063-6294a90a66b7 | 2026-05-01 | Warnings | M017 |
| 24 7 Relief and Recovery Pain Relieving | MENTHOL, UNSPECIFIED FORM | Triplicare Inc | 53ca807b-3ec2-4b5e-aa5a-6dcb756bb423 | 2026-04-30 | Warnings | M017 |
| FIRST AID BURN | LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE | 4 Visions LLC | 50b1351d-72dd-e0c9-e063-6294a90ac743 | 2026-04-30 | Warnings | M017 |
| TheraCare Flexible Pain Relieving | LIDOCAINE | Veridian Healthcare | 4f108002-2cae-0671-e063-6294a90ab6cf | 2026-04-30 | Warnings | M017 |
| Pain Relief Gel Roll On | MENTHOL | Trifecta Pharmaceuticals USA | 50b1a420-d5cd-6d61-e063-6294a90a0451 | 2026-04-30 | Warnings | M017 |
| Dr. Numb | LIDOCAINE AND BENZETHONIUM CHLORIDE CREAM | Shinpharma Inc | d8cdccdb-775b-4970-a6ea-50b62df221d6 | 2026-04-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Padagis Israel Pharmaceuticals Ltd | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 2026-04-29 | Warnings | M017 |
| anti itch | HYDROCORTISONE | HyVee Inc | e1db3641-2e83-4fec-8394-98d0d876ce0d | 2026-04-29 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 50805eee-33b3-86bd-e063-6294a90a77d8 | 2026-04-28 | Warnings | M017 |
| FixMySkin Healing Balm Vanilla Flavor | HYDROCORTISONE | Lovely Skin, Inc. | 52f7a561-a0b5-4562-a588-d74fd874b83a | 2026-04-28 | Warnings | M017 |
| Blue Star Medicated | CAMPHOR | Focus Consumer Healthcare, LLC | 56df008e-a23b-4870-e054-00144ff8d46c | 2026-04-27 | 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 |