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 18 of 153 · 3,057 matching rows.
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