Home NDC 65197-827 Bactine Max Antibiotic and Lidocaine Max Pain Relief
Product NDC 65197-827
11-digit product format 651970827
Labeler code 65197
Product ID 65197-827_4b43197b-b1f7-44b3-a750-7b10c685fa9a
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form OINTMENT
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-15
Substance LIDOCAINE HYDROCHLORIDE; BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength .04; 500; 10000 g/g; U/g; U/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Bactine Max Antibiotic and Lidocaine Max Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE .04 g/g BACITRACIN ZINC 500 U/g POLYMYXIN B SULFATE 10000 U/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup 89Y4M234ES Internal UNII lookup 19371312D4 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65197-827-05 Bactine Max Antibiotic and Lidocaine Max Pain Relief 14.2 g in 1 TUBE OINTMENT 14.2 3 65197-827-05 Bactine Max Antibiotic and Lidocaine Max Pain Relief 1 in 1 BOX OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-827 BACTINE MAX ANTIBIOTIC AND LIDOCAINE MAX PAIN RELIEF (LIDOCAINE) OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION] 3 Current NDC, 2 package rows 20250110_71300df9-6113-4f25-93ca-28ad7e7f79de.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 98 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d04799f-946d-ac53-e063-6294a90afeb7 2025-03-11 Warnings Exact identifier application number: M017 Muscle and Joint Care LIDOCAINE Vege Labs LLC. 301966b5-b535-dc04-e063-6394a90aec17 2025-03-11 Warnings Exact identifier application number: M017 Arctic Blast Pain Releiving MENTHOL, CAMPHOR (SYNTHETIC) Nutriomo Labs Pte, Ltd d5e7d26d-4f63-4b7b-a173-fe3a794c8459 2025-03-10 Warnings Exact identifier application number: M017 Anti Itch WALGREEN Walgreens 30014ff0-2519-4031-e063-6394a90ae07b 2025-03-10 Warnings Exact identifier application number: M017 Anti Itch ANTI ITCH Neilmed Pharmaceuticals Inc. 2fa74baf-e3d2-e099-e063-6394a90a1bae 2025-03-06 Warnings Exact identifier application number: M017 Thunder Fck Male Genital Desensitizer BENZOCAINE PRODUCT MAX GROUP INC 93188a42-0d3c-4159-bdc7-bbc5ec5c6744 2025-03-06 Warnings Exact identifier application number: M017 Body Action Climax Guard Delay BENZOCAINE PRODUCT MAX GROUP INC f88e0b42-974e-4f46-a93b-34b06320770a 2025-03-06 Warnings Exact identifier application number: M017 XENCARE INFLAMAX NATURAL TOPICAL PAIN MENTHOL, CAPSAICIN Xenex Laboratories Inc. 25b9621b-3c16-3cb9-e063-6294a90ab598 2025-03-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL PAIN WIZARD LIMITED LIABILITY COMPANY 1cd37b69-2cfb-130d-e063-6394a90af50b 2025-03-06 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Walgreens Co. c22bba5c-bb6f-494e-987a-f6e36c1b4893 2025-03-06 Warnings Exact identifier application number: M017 Redicare Burn Gel REDICARE BURN GEL Redicare LLC 947ac362-acfb-3508-e053-2a95a90a2873 2025-03-05 Warnings Exact identifier application number: M017 Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Exact identifier application number: M017 Peppermint soothing cream CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOL Henan Lijitang Medical Technology Co., Ltd. 2f6bc332-3006-710d-e063-6394a90acea5 2025-03-03 Warnings Exact identifier application number: M017 Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN FOURSTAR GROUP USA, INC. dcff0a2d-7190-4b0c-abde-ba009b8ef005 2025-02-28 Warnings Exact identifier application number: M017 GoodSense Anti-Itch DIPHENHYDRAMINE HCL, ZINC ACETATE Geiss, Destin & Dunn, Inc 2f38bdfc-6135-1b8a-e063-6294a90a6703 2025-02-28 Warnings Exact identifier application number: M017 Capsaicin 0.05% Cream CAPSAICIN 0.05% Puretek Corporation 2cf17a28-711f-77bd-e063-6394a90a7061 2025-02-28 Warnings Exact identifier application number: M017 Lidocaine Pain-Relief Patches LIDOCAINE PATCH Meijer, Inc 2f247929-6bff-1e59-e063-6394a90acdba 2025-02-27 Warnings Exact identifier application number: M017 Lightning Products BURN RELIEF LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 555ac696-e761-4a5a-bed8-945dc64d5be5 2025-02-27 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-827-05 65197082705 1 TUBE in 1 BOX (65197-827-05) / 14.2 g in 1 TUBE 1 tube 2024-01-15 No No Current