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 126 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Anti Itch	HYDROCORTISONE	L. Perrigo Company	ecd6d841-40b9-42c9-825d-d172cd04824d	2024-10-03	Warnings	Exact identifier application number: M017
Gold Bond Medicated Original Strength Body	MENTHOL	Navajo Manufacturing Company Inc.	f71d598c-92c3-d6fd-e053-6394a90a97d7	2024-10-03	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	9e663535-4acc-4b37-acae-8c17517c5a3d	2024-10-03	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	849c60fc-e455-4c50-8adf-ac59c0ee785b	2024-10-03	Warnings	Exact identifier application number: M017
rexall anti itch maximum strength relief	HYDROCORTISONE	Dolgencorp, LLC	894cf9ab-693a-4210-96df-605947f51b63	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	070000d7-7d4d-439b-9a91-851ba7c027e6	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone anti itch	HYDROCORTISONE	H E B	a1a9fed8-4938-48b5-81f1-d3942d534bb8	2024-10-03	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	ef9ea069-9b97-4bf5-aaac-deb85334dbd0	2024-10-03	Warnings	Exact identifier application number: M017
Basic Care Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	7fa13ab4-5f2d-4a48-816f-1b22d5f757b2	2024-10-03	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	fb2beb08-0ad6-a89d-e053-6294a90aa6fe	2024-10-02	Warnings	Exact identifier application number: M017
Geliga Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	da28097f-4b5c-6159-e053-2a95a90a7d96	2024-10-02	Warnings	Exact identifier application number: M017
Circatrix	CAPSAICIN	PureTek Corporation	cd3b1256-2df8-dc26-e053-2a95a90ad049	2024-10-02	Warnings	Exact identifier application number: M017
DermacinRx Penetral Cream	CAPSAICIN	PureTek Corporation	1e343a52-6071-3230-e054-00144ff8d46c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	36abfc2c-d424-4df8-968d-866342c96a56	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Balm	CAMPHOR MENTHOL	Eagle Indo Pharma, PT	87614869-9675-2c76-e053-2a95a90a48a9	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	d9a93daa-4e24-6690-e053-2a95a90a147c	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Extra Strength	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	5e02fbe3-5bc7-430e-b661-3a760ddd8fe0	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	c62a4313-2c07-5f58-e053-2995a90a083a	2024-10-02	Warnings	Exact identifier application number: M017
Eagle Medicated Aromatic	CAMPHOR MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	e272ec90-3cd9-5b70-e053-2a95a90a1df4	2024-10-02	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