Home NDC 71927-019 MEDI-FIRST
Product NDC 71927-019
11-digit product format 719270019
Labeler code 71927
Product ID 71927-019_5abd4200-f481-aca6-e063-6294a90ac4bc
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride, Lidocaine
Dosage form CREAM
Route TOPICAL
Labeler Orazen Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-29
Substance LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength 5; 1.3 mg/g; mg/g
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 · 32 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 product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71927-019-03 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71927-019-02 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 product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71927-019-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71927-019-02 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 product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71927-019-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71927-019-02 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 product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71927-019-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71927-019-02 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 product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71927-019-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71927-019-02 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 product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71927-019-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71927-019-03 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 product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71927-019-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71927-019-03 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 product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71927-019-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71927-019-03 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 5 mg/g BENZALKONIUM CHLORIDE 1.3 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012100 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# NDC, Effective, Indexing SPL table NDC Effective Indexing SPL Related label 71927-019-02 2025-09-03 2cef2736-ac00-d83d-e063-dadaa90ab31f 71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine 71927-019-02 2025-09-03 2cef2736-ac00-d83d-e063-dadaa90ab31f 71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine 71927-019-03 2025-09-03 2cef2736-b243-d83d-e063-dadaa90ab31f 71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine 71927-019-03 2025-09-03 2cef2736-b243-d83d-e063-dadaa90ab31f 71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine 71927-019-02 2025-01-30 2cef2736-ac00-d83d-e063-dadaa90ab31f 71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine 71927-019-02 2025-01-30 2cef2736-ac00-d83d-e063-dadaa90ab31f 71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine 71927-019-03 2025-01-30 2cef2736-b243-d83d-e063-dadaa90ab31f 71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine 71927-019-03 2025-01-30 2cef2736-b243-d83d-e063-dadaa90ab31f 71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71927-019-01 MEDI-FIRST 0.9 g in 1 POUCH CREAM 0.9 2 71927-019-01 MEDI-FIRST 0.9 g in 1 POUCH CREAM 0.9 2 71927-019-02 MEDI-FIRST 25 in 1 BOX CREAM 25 2 71927-019-03 MEDI-FIRST 25 in 1 BOX CREAM 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71927-019 MEDI-FIRST (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [ORAZEN INC] 1 Current NDC, 2 package rows 20230221_f522fb0b-3d86-b228-e053-2a95a90a55e9.zip 71927-019 MEDI-FIRST (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [ORAZEN INC] 1 Current NDC, 2 package rows 20230220_f508434f-5948-7134-e053-2a95a90a03d7.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 81 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MedPride Medicated Body Powder Powder MENTHOL, ZINC OXIDE Shield Line LLC cdb2fa5b-cf04-c876-e053-2a95a90a187c 2025-08-15 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL Troy Manufacturing, Inc. 40df30ba-41ba-42b7-93fe-4183b57bdb00 2025-08-14 Warnings Exact identifier application number: M017 Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 Warnings Exact identifier application number: M017 Lidocaine 3% LIDOCAINE HCL 3% PureTek Corporation 3bc94d52-fe52-9fd6-e063-6294a90a4340 2025-08-12 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. d8c42c8d-6ce0-43bf-b165-41979f3d8f79 2025-08-12 Warnings Exact identifier application number: M017 Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Saje Natural Business Inc. 3c194b8f-cfa5-11e3-e063-6394a90a92de 2025-08-11 Warnings Exact identifier application number: M017 Thera Plus Extra Strength Muscle Rub Topical Analgesic MENTHOL FOURSTAR GROUP USA, INC. 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50 2025-08-11 Warnings Exact identifier application number: M017 EARTHS CARE ARTHRITIS CAPSAICIN DLC Laboratories, Inc. 9460674b-057e-40b9-a0f9-ca3d92068d4f 2025-08-11 Warnings Exact identifier application number: M017 LILAS PERIOD MENTHOL Lilas Wellness, Inc. 5ea53b4b-45e6-48a7-8090-09c3a21e7f63 2025-08-11 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Roll-On LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 31639407-0f11-bde2-e063-6294a90af694 2025-08-10 Warnings Exact identifier application number: M017 Chinese Red Tiger Lidocaine Patches LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 20cd369c-3e98-3d8f-e063-6394a90a0824 2025-08-10 Warnings Exact identifier application number: M017 Treatonic LIDOCAINE PAIN RELIEF LIDOCAINE 4% 100 KARMA INC 3bd66b03-ac82-2d45-e063-6294a90a610a 2025-08-08 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Advanced Rx of Tennessee, LLC 3bdcef94-d06f-9152-e063-6294a90a6072 2025-08-08 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Advanced Rx of Tennessee, LLC 3bdd0c52-29d8-ab67-e063-6294a90a9c45 2025-08-08 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Advanced Rx of Tennessee, LLC 3bdd3015-349a-0fac-e063-6394a90afe41 2025-08-08 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Advanced Rx of Tennessee, LLC 3bdd6b3d-7180-288c-e063-6394a90a1785 2025-08-08 Warnings Exact identifier application number: M017 Good Sense Pain Relief Roll On LIDOCAINE HCL Geiss, Destin & Dunn, Inc 38e76fd6-e5fb-493c-e063-6294a90afed4 2025-08-08 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 71927-019-01 71927001901 0.9 g in 1 POUCH 0.9 g Historical 71927-019-02 71927001902 25 POUCH in 1 BOX (71927-019-02) / .9 g in 1 POUCH (71927-019-01) 25 pouch 2025-08-29 No No Current 71927-019-03 71927001903 25 POUCH in 1 BOX (71927-019-03) / .9 g in 1 POUCH (71927-019-01) 25 pouch 2025-09-03 No No Current