Bactine Max

Product NDC: 65197-811
11-digit product format: 651970811
Labeler code: 65197
Product ID: 65197-811_ec2ae48c-3497-4a66-a88c-4838a37ad3df
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride and lidocaine hydrochloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: WellSpring Pharmaceutical Corporation
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-06-22
Substance: BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength: .13; 4 g/100mL; 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

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.13 g/100mL
LIDOCAINE HYDROCHLORIDE	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2047877	Internal RxNorm lookup
2047879	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
28e8a311-20a4-45a1-8d5d-ca42b101c275	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
65197-811-14	Bactine Max	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		9
65197-811-15	Bactine Max	148 mL in 1 BOTTLE	LIQUID	148		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65197-811	BACTINE MAX (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]	9	Current NDC, Legacy NDC, 2 package rows	20250110_28e8a311-20a4-45a1-8d5d-ca42b101c275.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 2 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2eff98ba-5736-b07e-e063-6394a90aeea9	2026-09-04	Warnings	Exact identifier application number: M003
Walgreen Alcohol	ISOPROPYL ALCOHOL	Walgreens Company	deeae1ea-3d81-4260-95be-c4f328e3fdef	2026-09-04	Warnings	Exact identifier application number: M003
Dollar General	ISOPROPYL ALCOHOL	Dollar General Corporation	00b2ef34-42d9-523c-e063-6294a90a753d	2026-09-03	Warnings	Exact identifier application number: M003
Signature Select Alcohol Prep Pads	ISOPROPYL ALCOHOL	Better Living Brands LLC	31ce72e3-03a3-1608-e063-6394a90ad850	2026-09-03	Warnings	Exact identifier application number: M003
SurviveX Sting Relief	STING RELIEF WIPE	Changzhou Maokang Medical Products Co., Ltd.	5a83b1f1-c8dc-cf07-e063-6394a90a20ca	2026-09-03	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Kroger Co.	fe604470-917f-4cbd-a1e6-ac1dc7c57ff6	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	Rite Aid Corporation	5104f9ab-0b28-449f-a55a-5438713a24df	2026-09-02	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	UpLift Brands, LLC	5a81b635-d188-0b29-e063-6294a90a1e4b	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	7f518646-c8fe-499a-b5e4-8e5a5a90e01d	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	The Kroger Company	6551187f-5cde-4149-931f-b057bd760750	2026-09-02	Warnings	Exact identifier application number: M003
Unscented NasalGuard Antiseptic Topical	BENZALKONIUM CHLORIDE	TRUTEK CORP.	eb036e11-a28c-fdc0-e053-2a95a90a9cdb	2026-09-02	Warnings	Exact identifier application number: M003
Harris Teeter	ISOPROPYL ALCOHOL	Harris Teeter, LLC	d2bb20bd-ec83-8d80-e053-2a95a90a2bba	2026-09-02	Warnings	Exact identifier application number: M003
School Health	ISOPROPYL ALCOHOL	School Health Corporation	db5d0b22-f2d7-23e5-e053-2a95a90aeb51	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Topco Associates	2642298f-607e-fdca-e063-6394a90a69d9	2026-09-02	Warnings	Exact identifier application number: M003
HUSTLE BUTTER NUMBING	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	H.B.D. DIST. INC.	5b4d0390-dac6-4a71-9fdc-5c31543e7c5a	2026-09-02	Warnings	Exact identifier application number: M003
NasalGuard Antiseptic Topical Cool Menthol	BENZALKONIUM CHLORIDE	TRUTEK CORP.	e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8	2026-09-01	Warnings	Exact identifier application number: M003
Maximum Strength Betadine Clear	BENZALKONIUM CL AND PRAMOXINE HCL	Atlantis Consumer Healthcare, Inc.	31b94a76-1536-47c0-ab03-e487c2625c58	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a28101f-ea8e-6071-e063-6294a90aad91	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a3e62ce-52dc-121b-e063-6294a90a898f	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a49db18-c270-6f46-e063-6294a90afb5d	2026-08-31	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2047879	Bactine MAX 0.13 % / 4 % Topical Spray	PSN	28e8a311-20a4-45a1-8d5d-ca42b101c275	9
2047877	benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical Spray	PSN	28e8a311-20a4-45a1-8d5d-ca42b101c275	9
2047879	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical Spray [Bactine]	SBD	28e8a311-20a4-45a1-8d5d-ca42b101c275	9
2047877	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical Spray	SCD	28e8a311-20a4-45a1-8d5d-ca42b101c275	9
2047879	Bactine (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical Spray	SY	28e8a311-20a4-45a1-8d5d-ca42b101c275	9
2047879	Bactine (benzalkonium chloride 1.3 MG / lidocaine hydrochloride 40 MG) per ML Topical Spray	SY	28e8a311-20a4-45a1-8d5d-ca42b101c275	9
2047877	benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical Spray	SY	28e8a311-20a4-45a1-8d5d-ca42b101c275	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65197-811-14	65197081114	118 mL in 1 BOTTLE, PLASTIC (65197-811-14)	118 ml	2021-01-17	0000-00-00	No	No	Current
65197-811-15	65197081115	148 mL in 1 BOTTLE (65197-811-15)	148 ml	2018-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bactine ® Max Pain Relieving Cleansing Spray	WellSpring Pharmaceutical Corporation	2021-02-24	HUMAN OTC DRUG LABEL	9