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		2026-10-15
excluded package	package	65197-830	65197-830-03	D	Discontinued by firm		2026-10-15

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 62 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itch Eraser	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	2204e135-6a23-68a2-e063-6394a90ac019	2025-11-18	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	c8594e10-661f-6ff3-e053-2995a90ab4fc	2025-11-18	Warnings	Exact identifier application number: M017
Mag 5 PT Cooling Formula Recovery Cream	MENTHOL	RENU LABORATORIES, LLC	a45cde67-64ec-643b-e053-2a95a90a10b6	2025-11-18	Warnings	Exact identifier application number: M017
After Ivy Wipe	CAMPHOR	Tender Corporation d/b/a Adventure Ready Brands	21d98018-826a-1d0d-e063-6294a90a0a71	2025-11-17	Warnings	Exact identifier application number: M017
Itch Eraser Gel	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	223c7cfd-6dc5-140a-e063-6394a90a8332	2025-11-17	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Kroger Co.	6b3e7aac-395f-48cf-9c5e-f7e163724aef	2025-11-17	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	HY-VEE, INC	415ecfe9-3145-f23e-e063-6394a90adfd8	2025-11-17	Warnings	Exact identifier application number: M017
AY BENDITO - CBD	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	04b1d605-60aa-56f4-e063-6294a90ae760	2025-11-17	Warnings	Exact identifier application number: M017
AY BENDITO - CBD	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	0f1406fe-3a2f-bf36-e063-6294a90a7e5e	2025-11-17	Warnings	Exact identifier application number: M017
AY BENDITO CBD	MENTHOL, CAMPHOR	AY BENDITO INTERNATIONAL, INC	30a1c6b7-e37e-32c2-e063-6394a90aa354	2025-11-17	Warnings	Exact identifier application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000	MENTHOL, CAMPHOR	Worldwide Cosmetics, Inc	0816cc8f-8d0b-de27-e063-6294a90a8a9d	2025-11-17	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON COOLING	MENTHOL	Just Brands LLC	f6538e3e-4663-679c-e053-2995a90a87b5	2025-11-17	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON WARMING	CAMPHOR	Just Brands LLC	f65455d7-04a9-6217-e053-2995a90a7c90	2025-11-17	Warnings	Exact identifier application number: M017
JUST CBD - CBD AND THC ULTRA RELIEF	MENTHOL, CAMPHOR	Just Brands LLC	f664eb79-8897-3a49-e053-2995a90a37b4	2025-11-17	Warnings	Exact identifier application number: M017
JUST CBD RELIEF SOOTHING	LIDOCAINE HCL	Just Brands LLC	f9aff6e7-5702-f61c-e053-6294a90aa66f	2025-11-17	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING	MENTHOL, CAMPHOR	Just Brands LLC	0abece07-976c-4881-e063-6294a90a5c1b	2025-11-17	Warnings	Exact identifier application number: M017
Blue-Emu Thrive Pain Relief Cream	TRIPELENNAMINE 0.5%	Kingsway Pharmaceuticals dba NFI, LLC	a4ba6787-c99b-4bf2-9f8f-e923ef976212	2025-11-14	Warnings	Exact identifier application number: M017
CVS Cooling Patch	MENTHOL	CVS Pharmacy	42d97e29-f32d-a31b-e063-6394a90a88d8	2025-11-14	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Marlex Pharmaceuticals Inc	4de2bc60-dc4a-4417-984f-eabab0e926a6	2025-11-14	Warnings	Exact identifier application number: M017
EXTREME EMU	MENTHOL, METHYL SALICYLATE	Renu Laboratories, LLC	4393b57b-1e70-b8dd-e063-6294a90ae748	2025-11-14	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