Home NDC 65197-830 Bactine Max Bandage
Product NDC 65197-830
11-digit product format 651970830
Labeler code 65197
Product ID 65197-830_ce780255-5bba-4e68-ad28-279f0ca6b187
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form LIQUID
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-31
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100mL
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65197-830-03 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65197-830-03 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 65197-830-03 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 65197-830-03 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 65197-830-03 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 65197-830-03 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 65197-830-03 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 65197-830-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65197-830-03 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65197-830-03 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65197-830-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65197-830-03 557ba5c1ecfa…9c80585c8c6e…
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 Bandage
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100mL
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 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 65197-830-00 Bactine Max Bandage 10 mL in 1 BOTTLE, GLASS LIQUID 10 3 65197-830-00 Bactine Max Bandage 1 in 1 BOX LIQUID 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-830 BACTINE MAX BANDAGE (LIDOCAINE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION] 3 Current NDC, Legacy NDC, 2 package rows 20250110_465dc46e-6435-4569-9516-f648d0fe0f09.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 147 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GeriGentle FrostyHeat Pain Relief Patch Back MENTHOL Geri-Gentle Corporation e442b8ec-a3de-65e8-e053-2995a90af3ec 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 9f948fb4-4275-4a1f-83f8-cd708db4a296 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF PAIN RELIEF MENTHOL BLUE SPRING WELLNESS, L.L.C. b4278b70-e9a6-4d1f-bbad-257fe437b86a 2023-11-10 Warnings Exact identifier application number: M017 BLUE SPRING Foot and Leg Comfort Cream with Pain Relief MENTHOL, CAPSAICIN BLUE SPRING WELLNESS, L.L.C. 2f9cf514-48be-49ec-b424-0b228b4b874a 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 1231ddd2-7661-45b2-ab15-32f7fdc078a8 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE Stuff Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 7779b26b-ae3b-4639-a6b0-826c7ab37a86 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4 2023-11-10 Warnings Exact identifier application number: M017 SUPER BLUE STUFF Pain Relief Cream MENTHOL BLUE SPRING WELLNESS, L.L.C. 066a2106-2e25-4df6-9a8d-4417ba190205 2023-11-10 Warnings Exact identifier application number: M017 INVIGO FLEX Pain Relief Gel MENTHOL WYNNPHARM INC. 909e1d8c-c517-4d6a-8682-894f042c00f8 2023-11-10 Warnings Exact identifier application number: M017 ARNIMAX Penetrating Pain Relief Gel MENTHOL WYNNPHARM INC. 3a31f805-19c6-4036-a663-ebef9b212007 2023-11-10 Warnings Exact identifier application number: M017 KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Exact identifier application number: M017 ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions da004500-5e48-487b-b96f-520a3094096c 2023-11-10 Warnings Exact identifier application number: M017 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING MENTHOL, METHYL SALICYLATE Rexall Sundown, LLC 55c55f1c-d2b3-6363-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 NEUROFLEX Topical Pain Relieving Liquid CAMPHOR (SYNTHETIC), MENTHOL Almark Products Inc 6da3aa84-7a01-4041-8792-a4bbf49e6e4e 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR 60-second Pain Relief CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 3b74b542-202f-469e-8025-4372e95e6b01 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f8b8d1-a20b-54b0-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f92e71-fe2e-16f4-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M017 Teeter Renew Muscles Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC b90dc5b9-c31d-4770-a291-98d036ae8723 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR Foot and Leg Rub CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 57094238-506b-48c1-8eb9-fe904be80df0 2023-11-10 Warnings Exact identifier application number: M017 SKIN A COOL Hydrocortisone Anti-Itch HYDROCORTISONE Ana-Cool, LLC e3ea7406-e494-4038-9b28-8d0a28b4b834 2023-11-10 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65197-830-00 65197083000 1 BOTTLE, GLASS in 1 BOX (65197-830-00) / 10 mL in 1 BOTTLE, GLASS 2024-08-31 No No Current 65197-830-03 65197083003 1 BOTTLE, GLASS in 1 BOX (65197-830-03) > 10 mL in 1 BOTTLE, GLASS 2022-03-15 0000-00-00 No No Current