Home NDC 49314-0002 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.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1010769 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 131 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Feminine Anti-itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 19fe7c3b-58e2-6c16-e063-6394a90a612a 2024-06-03 Warnings Exact identifier application number: M017 THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE SCALP TECH INC 184be4cc-b0b9-7882-e063-6394a90a8e7e 2024-05-25 Warnings Exact identifier application number: M017 Methyl Salicylate 25 Percent METHYL SALICYLATE Alexso, Inc d8b8b0ba-69e9-4965-bf9b-6db21db69b34 2024-05-23 Warnings Exact identifier application number: M017 Meijer Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Meijer Distribution 07ecc6a7-bbe3-35cf-e063-6394a90a2180 2024-05-22 Warnings Exact identifier application number: M017 TheraCare Hydrocortisone Cream HYDROCORTISONE Veridian Healthcare 01cb7b47-2c3c-707d-e063-6294a90a5d97 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare c808aa05-9d49-cc9f-e053-2a95a90a50f3 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine and 1% Menthol Cream MENTHOL AND LIDOCAINE Veridian Healthcare c80ba251-91a5-0858-e053-2995a90a9cff 2024-05-21 Warnings Exact identifier application number: M017 HealthWise Menthol Roll-On MENTHOL Veridian Healthcare 102d57a5-6449-f825-e063-6294a90a8844 2024-05-21 Warnings Exact identifier application number: M017 SAFLY Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 3aca2568-d10f-4b14-861b-6c741c106829 2024-05-17 Warnings Exact identifier application number: M017 HealthWise Menthol 4% Roll-On MENTHOL Veridian Healthcare 1894ef00-ba05-0e02-e063-6394a90ab982 2024-05-16 Warnings Exact identifier application number: M017 Leader Poison Ivy Wash PRAMOXINE HYDROCHLORIDE LOTION Cardinal Health, 110 dba Leader 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c 2024-05-13 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Aromatic CAMPHOR, MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 0e808f89-62dc-3790-e063-6394a90a2351 2024-05-13 Warnings Exact identifier application number: M017 Walgreens Lidocaine Plus Cream BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE Walgreens Company e33e0097-31d6-8083-e053-2a95a90af5d2 2024-05-09 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Pain Relieving Cold Gel CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1794c512-5f42-4ec3-e063-6394a90a87cd 2024-05-03 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro MENTHOL AND CAMPHOR ACTIVE AND INNOVATIVE, LLC 17961a84-6bee-c75f-e063-6394a90af576 2024-05-03 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Pain Relieving Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd 2024-05-01 Warnings Exact identifier application number: M017 Lidocaine HCl 4 Percent LIDOCAINE HYDROCHLORIDE ARI BRANDS, LLC 81aff5c5-91c0-4173-a432-d20115613580 2024-04-30 Warnings Exact identifier application number: M017 HealthWise 3x Medicated Pain Relief Patch 120 Bulk CAMPHOR,MENTHOL, METHYL SALICYLATE Veridian Healthcare 17545078-05e1-9338-e063-6394a90a678c 2024-04-30 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Roll-on CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1755ec89-c404-1c17-e063-6394a90ab9fb 2024-04-30 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Roll On MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bc2a14-6bda-428c-e053-2995a90a4ced 2024-04-29 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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