A-Cute Derm B-Kleer

Product NDC: 68605-1040
11-digit product format: 686051040
Labeler code: 68605
Product ID: 68605-1040_3abba027-97ff-4ae6-8fa8-66e544bf9fd0
Type: HUMAN OTC DRUG
Nonproprietary name: Benzethonium Chloride
Dosage form: GEL
Route: CUTANEOUS
Labeler: ABBE Laboratories, Inc.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-01
Substance: BENZETHONIUM CHLORIDE
Active strength: 2 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: A-Cute Derm B-Kleer
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZETHONIUM CHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PH41D05744	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1243889	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
544333fe-6c3a-485b-b899-e029d97ea962	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68605-1040-2	A-Cute Derm B-Kleer	946.35 mL in 1 BOTTLE, PLASTIC	GEL	946.35	3
68605-1040-4	A-Cute Derm B-Kleer	118.29 mL in 1 BOTTLE, PLASTIC	GEL	118.29	3
68605-1040-8	A-Cute Derm B-Kleer	236.59 mL in 1 BOTTLE, PLASTIC	GEL	236.59	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68605-1040	A-CUTE DERM B-KLEER (BENZETHONIUM CHLORIDE) GEL [ABBE LABORATORIES, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20240202_544333fe-6c3a-485b-b899-e029d97ea962.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 16 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACITRACIN	BACITRACIN	CVS Pharmacy	15ea4415-943a-4d0a-ac23-5f37cd2cf206	2024-10-22	Warnings	Exact identifier application number: M004
Tetracyte First Aid and Antibiotic Topical	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	dcb3d96a-41a5-40d8-a47e-56d419bbe6e2	2024-10-21	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	CVS Pharmacy	3ba24e32-7078-45fb-85d1-2ab252fa9cb5	2024-10-16	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	43486da5-6e8b-45c0-bd7e-cc2d8b28c510	2024-10-16	Warnings	Exact identifier application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin Zinc	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production (Xiamen) Co., Ltd.	af08c1fe-fb1a-56d2-e053-2a95a90a67c4	2024-10-15	Warnings	Exact identifier application number: M004
Exchange Select First Aid Triple Anitbiotic Pain Relieving	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Army & Air Force Exchange Service	1c7f1700-69c0-4a71-8bb0-a71e3082efeb	2024-10-14	Warnings	Exact identifier application number: M004
antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	55fa94cb-7e1c-41bc-879a-5618a828f14a	2024-10-14	Warnings	Exact identifier application number: M004
first aid antibiotic and pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer, Inc.	f0892a30-8a88-44e8-ab04-0e87c12f9c44	2024-10-14	Warnings	Exact identifier application number: M004
triple antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	d97a69e8-4058-4c77-b628-ad3e2b97a620	2024-10-14	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	b541f1a9-7e40-4c35-840f-ea1e357b580e	2024-10-14	Warnings	Exact identifier application number: M004
Exchange Select triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Army & Air Force Exchange Service	b7bf899c-44e5-48d6-bf8e-d843fd442432	2024-10-12	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Topco Associates LLC	675665ee-bd0d-4168-81b8-341b1258c102	2024-10-12	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Changjian Medical Products Co., Ltd.	34e8776c-1f36-4e1b-9d71-727591ac904d	2024-10-11	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	H E B	58a4d263-e234-43cd-a3bd-b19a492174d9	2024-10-11	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	5e0fc39b-e6d4-4543-8afc-2881e2f85f9b	2024-10-06	Warnings	Exact identifier application number: M004
Good Sense Triple Antibiotic and Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	c3e9215f-fcef-4938-8208-df4099652289	2024-10-06	Warnings	Exact identifier application number: M004
triple antibiotic plus maximum strength	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	c428b0a3-e80a-493c-ac67-807ebca3ce01	2024-10-06	Warnings	Exact identifier application number: M004
Basic Care First Aid Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amazon.com Services LLC	a9247f69-0366-42dd-ae0d-39a2a6976cdc	2024-10-06	Warnings	Exact identifier application number: M004
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PH41D05744	BENZETHONIUM CHLORIDE	121-54-0	BENZETHONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243889	benzethonium chloride 0.2 % Medicated Liquid Soap	PSN	544333fe-6c3a-485b-b899-e029d97ea962	3
1243889	benzethonium chloride 2 MG/ML Medicated Liquid Soap	SCD	544333fe-6c3a-485b-b899-e029d97ea962	3
1243889	benzethonium chloride 0.2 % Medicated Liquid Soap	SY	544333fe-6c3a-485b-b899-e029d97ea962	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68605-1040-2	68605104002	946.35 mL in 1 BOTTLE, PLASTIC (68605-1040-2)	946.35 ml	2022-05-01	0000-00-00	No	No	Current
68605-1040-4	68605104004	118.29 mL in 1 BOTTLE, PLASTIC (68605-1040-4)	118.29 ml	2022-05-01	0000-00-00	No	No	Current
68605-1040-8	68605104008	236.59 mL in 1 BOTTLE, PLASTIC (68605-1040-8)	236.59 ml	2022-05-01	0000-00-00	No	No	Current
68605-1040-9	68605104009	1 BOTTLE, PLASTIC in 1 BOX (68605-1040-9) > 29.57 mL in 1 BOTTLE, PLASTIC (68605-1040-1)		2022-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
A-Cute Derm B-Kleer - ABBE Laboratories, Inc.	ABBE Laboratories, Inc.	2026-01-24	HUMAN OTC DRUG LABEL	3