Balma Septic Antiseptic Hand Wash

Product NDC: 59503-6265
11-digit product format: 595036265
Labeler code: 59503
Product ID: 59503-6265_2b5e378a-fb99-e8b5-e063-6294a90a0baa
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: SOAP
Route: TOPICAL
Labeler: Rochester Midland Corporation
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-05-09
Substance: BENZALKONIUM CHLORIDE
Active strength: 25 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	59503-6265		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59503-6265	59503-6265-6	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59503-6265	59503-6265-2	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: Balma Septic Antiseptic Hand Wash
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1046529	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
1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59503-6265-2	Balma Septic Antiseptic Hand Wash	3785 mL in 1 BOTTLE, PLASTIC	SOAP	3785		5
59503-6265-6	Balma Septic Antiseptic Hand Wash	2500 mL in 1 BOTTLE, PLASTIC	SOAP	2500		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59503-6265	BALMA SEPTIC ANTISEPTIC HAND WASH (BENZALKONIUM CHLORIDE) SOAP [ROCHESTER MIDLAND CORPORATION]	5	Current NDC, Legacy NDC, 2 package rows	20250112_1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528.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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Kroger Company	e31c8d92-bf9f-4b7f-8f81-54199745cd20	2024-10-06	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	American Sales Company	9df0c4c2-f045-4f25-878e-4d55a99b8df4	2024-10-06	Warnings	Exact identifier application number: M004
DG Health Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	0a04da51-d169-4eff-b70c-352913ce3966	2024-10-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	8d5bac6b-98b6-4fc4-983a-ca5292b4c361	2024-10-06	Warnings	Exact identifier application number: M004
antibiotic plus pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Kroger Company	91828614-d0d1-472f-802f-43f473860125	2024-09-26	Warnings	Exact identifier application number: M004
DG Health Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp Inc	efaf3ea5-0a2f-414f-96eb-7e8cfba9e901	2024-09-26	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	29c223ff-3cb7-4578-a326-08516e89cd47	2024-09-26	Warnings	Exact identifier application number: M004
Signature Care First Aid Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	78ecfb28-f4c4-4f70-90c9-d6d7bf920fb5	2024-09-26	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amerisource Bergen	3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40	2024-09-26	Warnings	Exact identifier application number: M004
Rexall Antibiotic	BACITRACIN	Dolgencorp, LLC	7ad42602-6e42-47c8-91a8-e4785fa8d24b	2024-09-23	Warnings	Exact identifier application number: M004
bacitracin	BACITRACIN	H E B	0a5eeef0-309b-4edd-a664-3d9c1c74a6e9	2024-09-23	Warnings	Exact identifier application number: M004
signature care first aid antibiotic	BACITRACIN	Safeway	38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1	2024-09-23	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN	Topco Associates LLC	3267a695-9e53-42f2-b30a-022653a0b8bb	2024-09-23	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Kroger Company	4490cece-0635-4ea7-91ab-324a971fef63	2024-09-23	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Padagis Israel Pharmaceuticals Ltd	28fff253-ddd4-4669-aa90-b4caf48c905f	2024-09-22	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Safeway	044aff98-f398-40f5-8c18-2751b4ab4384	2024-09-18	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	American Sales Company	09a0b0b9-1806-4ff9-80fa-448dabbf2cc7	2024-09-18	Warnings	Exact identifier application number: M004
equaline first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	United Natural Foods, Inc. dba UNFI	022e009e-0192-4089-86f3-4d63448e0f88	2024-09-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Kroger Company	c531bac4-ab15-4fde-99a7-19e20ce10387	2024-09-17	Warnings	Exact identifier application number: M004
basic care first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Amazon.com Services LLC	c159b18d-0d6e-409f-8b2b-e8f28cd85633	2024-09-17	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046529	benzalkonium chloride 2.5 % Medicated Liquid Soap	PSN	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	5
1046529	benzalkonium chloride 25 MG/ML Medicated Liquid Soap	SCD	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	5
1046529	benzalkonium chloride 2.5 % Medicated Liquid Soap	SY	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59503-6265-2	59503626502	3785 mL in 1 BOTTLE, PLASTIC (59503-6265-2)	3785 ml	2017-05-09	0000-00-00	No	No	Current
59503-6265-6	59503626506	2500 mL in 1 BOTTLE, PLASTIC (59503-6265-6)	2500 ml	2017-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Balma Septic Antiseptic Hand Wash 6265 Drug Facts and Label	Rochester Midland Corporation \| ABC Compounding Co., Inc.	2025-01-10	HUMAN OTC DRUG LABEL	5