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 |
|---|---|---|---|---|---|---|
| OWELL NATURALS NEUROPATHY MAXIMUM STRENGTH | MENTHOL | OWELL NATURAL 8 LLC | 56b8d0cc-2f35-7d38-e063-6294a90ad06d | 2026-07-16 | Warnings | M017 |
| ANTIPHLAMINE | L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE | Masaem Company | 56b93c89-295b-f33a-e063-6294a90a5fe4 | 2026-07-16 | Warnings | M017 |
| Meriwether Skin Pain Relief | MENTHOL, UNSPECIFIED FORM | Meriwether Skin LLC | f6e155be-5879-4176-bb0e-e364f2e5cdf9 | 2026-07-16 | Warnings | M017 |
| Medi-First Muscle Rub Cream | MENTHOL, METHYL SALICYLATE | Unifirst First Aid Corporation | 56a6b8b2-7ab0-9854-e063-6294a90ab5ba | 2026-07-15 | Warnings | M017 |
| Painsil Pain Relief Roll-On | LIDOCAINE HYDROCHLORIDE | Painsil LLC | dee39dff-5749-4ef2-a9ed-182f25e01f67 | 2026-07-14 | Warnings | M017 |
| VARICOSE VEINS MAXIMUM STRENGTH | MENTHOL | OWELL NATURAL & LLC | 5692914f-1b14-e3e3-e063-6394a90a94bf | 2026-07-14 | Warnings | M017 |
| ZyloRelief | LIDOCAINE HYDROCHLORIDE | Highmark Pharma LLC | 635f5b98-f74c-495f-a537-686fcba9ccad | 2026-07-14 | Warnings | M017 |
| ENOKON PAIN RELIEF Spray. | PAIN RELIEF SPRAY. | Henan Enokon Medical Instrument Co., Ltd. | 5675ec21-b947-2206-e063-6294a90aa509 | 2026-07-12 | Warnings | M017 |
| Topcare Pain Relief Patch | PAIN RELIEF PATCH MEDICATED 5% MENTHOL | 76162 | 4f00d0b8-d2f4-843b-e063-6294a90a332b | 2026-07-12 | Warnings | M017 |
| Penetral Roll-on | CAPSAICIN 0.025% | PureTek Corporation | 56204c03-8b15-a8b5-e063-6394a90a8189 | 2026-07-10 | Warnings | M017 |
| Intensive Healing Itch Relief | ITCH RELIEF CREAM | NeilMed Pharmaceuticals Inc | 563ef1d5-2180-bc45-e063-6294a90a813d | 2026-07-10 | Warnings | M017 |
| AVON Foot Works Arthritis Achy Foot and Muscle | METHYL SALICYLATE | COSMAX USA, CORPORATION | 56440d3f-bc93-cebb-e063-6294a90a5f79 | 2026-07-10 | Warnings | M017 |
| CHEONG KUN PAIN RELIEVING | CAMPHOR | CHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED | 557d5cb3-2a05-4f45-e063-6394a90a9b12 | 2026-07-10 | Warnings | M017 |
| Biofreeze Professional | MENTHOL | Reckitt Benckiser LLC | 485c8208-c93b-5b84-e063-6394a90ab77a | 2026-07-10 | Warnings | M017 |
| Fit Mist Pain Relief | MENTHOL | Aroma Sensations Inc | f5a98544-8bd7-42dc-a594-5559e3920e29 | 2026-07-09 | Warnings | M017 |
| Nuturna Sciatica | MENTHOL | Micelle Laboratories, Incorporated | ff200864-bedf-4138-bdec-2b23701406dd | 2026-07-09 | Warnings | M017 |
| Lidocaine cream | DRS LIDOCAINE 5% CREAM | OL PHARMA TECH LLC. (Drs. Pharmacy) | 372fe018-1e5a-9ec4-e063-6294a90a1500 | 2026-07-09 | Warnings | M017 |
| Nupharmisto 4% Lidocaine Numbing cream | LIDOCAINE 4% | EveryMarket Inc | 5615e49d-e03b-f915-e063-6294a90a1786 | 2026-07-08 | Warnings | M017 |
| CAREALL Musle and Joint | MENTHOL | New World Imports, Inc | 561cc103-ae88-8f30-e063-6294a90a05c4 | 2026-07-08 | Warnings | M017 |
| HealthWise Medicated Cold Hot | MENTHOL | Veridian Healthcare, LLC | 561e1409-d1d8-e35d-e063-6394a90a4d8f | 2026-07-08 | 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 |