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 132 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Genuine First Aid Alcohol Cleansing Pad	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	c39c4d80-9718-459f-8ae4-ada043bba5b7	2024-06-26	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bd5cf69-9a08-5e2e-e063-6394a90a03cd	2024-06-26	Warnings	Exact identifier application number: M017
Solarcaine Burn Pain Relief 4oz	SOLARCAINE BURN PAIN RELIEF 4OZ	WellSpring Pharmaceutical Corporation	2c0389db-ceb2-422b-9575-bdb8fe649a1e	2024-06-26	Warnings	Exact identifier application number: M017
astonea	HYDROCORTISONE	ASTONEA LABS PRIVATE LIMITED	de09e859-c5fd-0cc5-e053-2a95a90a147e	2024-06-25	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	0190196d-5f78-042b-e063-6294a90a3714	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bc1bf83-91ee-ec9d-e063-6394a90a3daf	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1bc2f688-d0c4-690e-e063-6294a90abc38	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1b9fdac0-9fb0-e669-e063-6394a90aece9	2024-06-24	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Asclemed USA, Inc.	97d506bd-3215-4e2e-9914-af1c174dd4ab	2024-06-20	Warnings	Exact identifier application number: M017
ABREVA Rapid Pain Relief	GLYCERIN, LIDOCAINE	Haleon US Holdings LLC	65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d	2024-06-20	Warnings	Exact identifier application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain Reliever	CAPSAICIN	WHY ENTERPRISES LLC	e32acb5f-5bc3-4228-b037-6315d080f556	2024-06-17	Warnings	Exact identifier application number: M017
PUREGEN LABS Pain Relief 4 Lidocaine	LIDOCAINE	Advanced Rx LLC	9dff40d8-8d7e-4629-bea5-987f5e68477d	2024-06-11	Warnings	Exact identifier application number: M017
SMOOTH GATOR Head-Ezz Analgesic	MENTHOL	Smooth Gator LLC	02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	2024-06-10	Warnings	Exact identifier application number: M017
FIRST AID BURN	LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE	Epic Medical Supply Corp	bd1b1873-e900-45eb-96a0-28f782b5a7cd	2024-06-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	1c834ba0-86b6-8e61-e063-6394a90a192d	2024-06-04	Warnings	Exact identifier application number: M017
HealthWise Feminine Anti-itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	19fe7c3b-58e2-6c16-e063-6394a90a612a	2024-06-03	Warnings	Exact identifier application number: M017
THE SOLUTION NUMBING	LIDOCAINE HYDROCHLORIDE	SCALP TECH INC	184be4cc-b0b9-7882-e063-6394a90a8e7e	2024-05-25	Warnings	Exact identifier application number: M017
Methyl Salicylate 25 Percent	METHYL SALICYLATE	Alexso, Inc	d8b8b0ba-69e9-4965-bf9b-6db21db69b34	2024-05-23	Warnings	Exact identifier application number: M017
Meijer Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Meijer Distribution	07ecc6a7-bbe3-35cf-e063-6394a90a2180	2024-05-22	Warnings	Exact identifier application number: M017
TheraCare Hydrocortisone Cream	HYDROCORTISONE	Veridian Healthcare	01cb7b47-2c3c-707d-e063-6294a90a5d97	2024-05-21	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