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		2026-10-16
excluded package	package	65197-830	65197-830-03	D	Discontinued by firm		2026-10-16

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 143 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoidal Pain Relief Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	WALGREENS	03bbe146-f185-bcfa-e063-6394a90a85bf	2023-12-04	Warnings	Exact identifier application number: M017
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Exact identifier application number: M017
TACT	DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL	Sato Pharmaceutical Inc., Ltd.	b6e2ee24-69de-4dfd-9081-b9537b7a7bad	2023-12-04	Warnings	Exact identifier application number: M017
Overnight Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	2cbd0966-4cf9-4271-bd53-6672b1ed2a99	2023-12-04	Warnings	Exact identifier application number: M017
Prolayed Lidocaine Male Genital Desensitizer	LIDOCAINE	ViaDerma Distribution, Inc.	9c5ad0d0-ca7a-4321-9334-f06f3f6be18f	2023-12-02	Warnings	Exact identifier application number: M017
Liberdol Topical Analgesic	METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)	ViaDerma Distribution, Inc	ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8	2023-12-01	Warnings	Exact identifier application number: M017
Prolayed	LIDOCAINE	MATRIX MIXOLOGY, INC	ae317876-adb1-6d13-e053-2995a90a74af	2023-12-01	Warnings	Exact identifier application number: M017
Tact Cool Jelly	DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL	Sato Pharmaceutical Co., Ltd.	f34872c9-91b9-49db-8e41-5b54a069284a	2023-12-01	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	348fde05-2797-4410-a1b2-99e64187c4fe	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Proficient Rx LP	85a7809e-c43f-4138-a85b-44e1b586def5	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	66681906-c5f5-4c57-bb43-9c83cccc0062	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Patch	LIDOCAINE, MENTHOL	Proficient Rx LP	c0df4b8b-2679-4652-9144-a8db916a186b	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	7c300dec-cefd-4b79-a948-a917b7708a04	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	2adf3c4d-636f-4e02-b501-946b4df5f5d6	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE, MENTHOL	Proficient Rx LP	488d665c-a4fe-4a69-bab3-34b2347f4b05	2023-12-01	Warnings	Exact identifier application number: M017
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	Warnings	Exact identifier application number: M017
Thera Plus Cool and Heat Pain Relieving Gel Menthol	MENTHOL	Fourstar Group USA, Inc.	0a225714-ccb1-4676-e063-6294a90aeeb2	2023-11-30	Warnings	Exact identifier application number: M017
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Exact identifier application number: M017
Ice Quake	MENTHOL	Southern Sales & Service, Inc.	7a05832f-49ac-4013-b240-4405501e45cd	2023-11-29	Warnings	Exact identifier application number: M017
ICE MUSCLE RUB Leon M.C	MENTHOL	Southern Sales & Service, Inc.	4efaf347-7406-4690-8005-e7cf2e3d4222	2023-11-29	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