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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65197-830		D	Discontinued by firm		2026-10-12
excluded package	package	65197-830	65197-830-03	D	Discontinued by firm		2026-10-12

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
465dc46e-6435-4569-9516-f648d0fe0f09	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

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 34 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	4a7f92d3-dd35-44a3-e063-6294a90ae004	2026-02-10	Warnings	Exact identifier application number: M017
NICOVITO HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5e24fa-959e-79b4-e063-6294a90a8f68	2026-02-09	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	2e7638c6-e1ce-4e2f-bd50-52fbce5a138e	2026-02-09	Warnings	Exact identifier application number: M017
Tiger Balm Neck and Shoulder Rub	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	2f272d12-7b34-430e-817e-1005f57ed9e9	2026-02-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA CORP	4303fd30-0d35-3671-e063-6394a90a2aee	2026-02-09	Warnings	Exact identifier application number: M017
Pain Relief Lidocaine	LIDOCAINE	Kroger Company	4098756e-3d9f-317a-e063-6394a90af04c	2026-02-09	Warnings	Exact identifier application number: M017
Aquanil HC	HYDROCORTISONE	Person and Covey	4a698246-05a6-d01f-e063-6294a90a3401	2026-02-09	Warnings	Exact identifier application number: M017
Hemorrhoid Master	LIDOCAINE, PHENYLEPHRINE	Ebanel Laboratories, Inc	41292d65-dabe-4bc3-872f-34a3912aa342	2026-02-09	Warnings	Exact identifier application number: M017
DERMFREE NEUROPATHY	ARNICA MONTANA 1X HPUS 7% NEUROPATHY	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5c232d-5d29-2504-e063-6394a90ac9de	2026-02-08	Warnings	Exact identifier application number: M017
ASSIELF NUMBING Topical Anorectal	LIDOCAINE	Shenzhen Yuanbang International Logistics Co., Ltd	4a5cb477-57ef-2a1d-e063-6394a90ac9ed	2026-02-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieve Gel-Patch	PAIN RELIEVE GEL-PATCH	Henan Kangdi Medical Devices Co., Ltd	1e31b950-e990-e255-e063-6394a90a7d23	2026-02-07	Warnings	Exact identifier application number: M017
Herbal Knee Patch	HERBAL KNEE PATCH	Henan Kangdi Medical Devices Co., Ltd	2a009059-b515-8214-e063-6294a90a4ed3	2026-02-07	Warnings	Exact identifier application number: M017
Flocean ANTI-ITCH	BENZOCAINE 5%ANTI-ITCH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a493911-a846-5aa0-e063-6294a90a65ac	2026-02-07	Warnings	Exact identifier application number: M017
daily solutions Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Garcoa, Inc.	4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6	2026-02-06	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Shenzhen Wankelai E-commerce Co., Ltd.	4a22562b-601e-97d7-e063-6394a90a5bca	2026-02-06	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Sportpharm LLC	ee64ad1e-78db-4553-a3cf-b539b770fa26	2026-02-06	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE 4%	Sportpharm LLC	1dd022b9-88ae-4737-88cc-fdb0ce0a83a3	2026-02-06	Warnings	Exact identifier application number: M017
Camphor plus Lidocaine Pain Relief	CAMPHOR, LIDOCAINE	Veridian Healthcare	4a2b73a8-c10c-85f9-e063-6294a90ac52c	2026-02-06	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Retail Business Services, LLC	073c72fe-3171-4a4f-913a-d1b9630a1af3	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M017
HealthWise Soothing Lidocaine Pain Relief	LIDOCAINE HCI 0.5%	Veridian Healthcare	4a2ec73e-7332-6f13-e063-6294a90a8506	2026-02-06	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
98PI200987	LIDOCAINE	137-58-6	Lidocaine

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bactine ® Max Liquid Bandage	WellSpring Pharmaceutical Corporation	2023-12-21	HUMAN OTC DRUG LABEL	3
Bactine ® Max Liquid Bandage	WellSpring Pharmaceutical Corporation	2021-08-19	HUMAN OTC DRUG LABEL	1