Home NDC 78495-142 MEDI-FIRST Topical Analgesic
Product NDC 78495-142
11-digit product format 784950142
Labeler code 78495
Product ID 78495-142_5aebcb33-8dcd-d9bc-e063-6294a90a555e
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCI
Dosage form SPRAY
Route TOPICAL
Labeler Ultra Distributors Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-19
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 2027-12-31
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 · 14 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 2025-04-01 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 78495-142-01 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 78495-142-01 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 78495-142-01 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 78495-142-01 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 78495-142-01 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 78495-142-01 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 78495-142-01 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 MEDI-FIRST Topical Analgesic
Listing expiration 2027-12-31 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 78495-142-01 MEDI-FIRST Topical Analgesic 59.1 mL in 1 BOTTLE, PUMP SPRAY 59.1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78495-142 MEDI-FIRST TOPICAL ANALGESIC (LIDOCAINE HCI) SPRAY [ULTRA DISTRIBUTORS INC] 2 Current NDC, Legacy NDC, 1 package rows 20250409_b6f288f7-9ae3-215e-e053-2a95a90aedf6.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 102 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Exact identifier application number: M017 myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol MENTHOL Inspec Solutions LLC d4276749-eeff-28f7-e053-2a95a90a593d 2025-01-31 Warnings Exact identifier application number: M017 MyDerm Bite Relief BENZOCAINE Inspec Solutions LLC. 88615668-16b5-7840-e053-2a95a90a9208 2025-01-31 Warnings Exact identifier application number: M017 Maximum Strength Blue Emu Pain Relief Blu Emu TROLAMINE SALICYLATE Kingsway Pharmaceuticals dba NFI, LLC 5e02b820-e53a-42cb-abdb-2925617c29ca 2025-01-31 Warnings Exact identifier application number: M017 Sunset Novelties Herquake NUMBING LUBRICANT SUNSET INTIMATES GROUP INC 2ceeca3e-9197-9166-e063-6394a90ae908 2025-01-30 Warnings Exact identifier application number: M017 Magsoothium CBD Cooling Roll on Relief MENTHOL Ubu/Elements, Inc. 2cf05dcd-6a44-de08-e063-6394a90aaba0 2025-01-30 Warnings Exact identifier application number: M017 Meijer Vagicaine 20% BENZOCAINE AND 3% RESORCINOL CREAM Meijer, Inc. dac73a07-7569-4788-977a-f10d098da75d 2025-01-30 Warnings Exact identifier application number: M017 ZCort Ultra HYDROCORTISONE ACETATE 1% RxDino, LLC b68f8ada-58e8-e8e4-e053-2a95a90ab02d 2025-01-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relieving Gel-Patch LIDOCAINE 4% Noble OTC LLC 12a3ce63-6fce-0993-e063-6294a90a40d5 2025-01-28 Warnings Exact identifier application number: M017 INTIMALE LIDOCAINE DELAY LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 5ddd7d56-bf51-462b-afcd-944861e49781 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Relax Massage CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0eae24e-09cf-0d2d-e053-2a95a90acedc 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebbc0f-9888-b812-e053-2a95a90a5d3d 2025-01-28 Warnings Exact identifier application number: M017 CBDMEDIC Arthritis Aches and Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec7255-bb36-41cd-e053-2a95a90aeac4 2025-01-28 Warnings Exact identifier application number: M017 CBDMEDIC Back and Neck Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec8fc9-c401-5f23-e053-2995a90acb1c 2025-01-28 Warnings Exact identifier application number: M017 Muscle Therapy METHYL SALICYLATE, CAMPHOR Everlaan Organics Inc 0890a683-9a66-fdbd-e063-6294a90ae526 2025-01-27 Warnings Exact identifier application number: M017 Joint Therapy CAMPHOR Everlaan Organics Inc 08904b77-d6db-8b82-e063-6394a90ace4f 2025-01-27 Warnings Exact identifier application number: M017 Warrior Arthritis Relief TROLAMIN SALICYLATE 10% Derma Care Research Labs, LLC 013f48b9-913f-b283-e063-6394a90abd73 2025-01-27 Warnings Exact identifier application number: M017 DCH Cool and Heat MENTHOL 16% Derma Care Research Labs, LLC ff323282-612c-eaf8-e053-6394a90ab779 2025-01-27 Warnings Exact identifier application number: M017 Gerigentle HYDROCORTISONE GERI-GENTLE CORPORATION 0adfa2f0-9758-5c54-e063-6294a90a461f 2025-01-25 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 Marketing end Sample Exclude flag Status 78495-142-01 78495014201 59.1 mL in 1 BOTTLE, PUMP (78495-142-01) 59.1 ml 2020-12-19 0000-00-00 No No Current