FAK Care4 Bus and School Yellow ORM D

Product NDC: 50814-042
11-digit product format: 508140042
Labeler code: 50814
Product ID: 50814-042_2c4cbe6c-c27a-15fe-e063-6294a90ac409
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL
Dosage form: KIT
Labeler: GFA Production (Xiamen) Co., Ltd.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-08
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: FAK Care4 Bus and School Yellow ORM D
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204602	Internal RxNorm lookup
797544	Internal RxNorm lookup
1012100	Internal RxNorm lookup
1038558	Internal RxNorm lookup
1046313	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
3b5d07c6-bda2-4bc7-89b8-88280d11ed74	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50814-002-01	FAK Care4 Bus and School Yellow ORM D	0.45 g in 1 POUCH	SWAB	0.45 g	0.13 g in 100g	7
50814-002-01	FAK Care4 Bus and School Yellow ORM D	1 in 1 BOX	SWAB		0.13 g in 100g	7
50814-009-01	FAK Care4 Bus and School Yellow ORM D	0.9 g in 1 PACKAGE	CREAM	0.9 g	1.3 mg in 1g	7
50814-039-01	FAK Care4 Bus and School Yellow ORM D	1 in 1 BOX	SWAB		700 mg in 1g	7
50814-039-01	FAK Care4 Bus and School Yellow ORM D	0.45 g in 1 BAG	SWAB	0.45 g	700 mg in 1g	7
50814-041-02	FAK Care4 Bus and School Yellow ORM D	0.53 mL in 1 POUCH	SWAB	0.53 mL	600 mg in 1mL	7
50814-042-01	FAK Care4 Bus and School Yellow ORM D	1 in 1 KIT	KIT	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50814-042	FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]	7	Current NDC, Legacy NDC, 7 package rows	20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balma Septic Antiseptic Hand Wash	BENZALKONIUM CHLORIDE	Rochester Midland Corporation	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	2025-01-10	Warnings	Exact identifier application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380	CHLOROXYLENOL	ABC Compounding Co., Inc.	efa3938f-64de-77ba-e053-2a95a90ac840	2025-01-10	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	64aa660d-2d69-48e8-bd0d-4876815d89ff	2025-01-08	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Water-Jel Technologies	412928a1-3708-4fa8-99c5-aaa2b079cf6e	2025-01-06	Warnings	Exact identifier application number: M004
AVON HeXashield Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Tai Guk Pharm. Co., Ltd.	8e0cb861-d8aa-1f71-e053-2a95a90aaa88	2025-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA LLC	087694c2-4b1b-e293-e063-6294a90a961f	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	TRIFECTA PHARMACEUTICALS USA LLC	0c017b10-29b6-e30f-e063-6294a90a8a3c	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	0bf08cf6-be3f-f9aa-e063-6294a90a4393	2024-12-31	Warnings	Exact identifier application number: M004
Single Antibiotic with Bacitracin	BACITRACIN ZINC	Randob Labs Ltd.	2a807f1b-986f-a9ea-e063-6394a90aed25	2024-12-30	Warnings	Exact identifier application number: M004
Tripleantibioticapainscaritch	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	935106c6-8a9e-07fa-e053-2a95a90a2484	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	00c52a31-9bfa-a8bf-e063-6294a90ac4d7	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	Trifecta Pharmaceuticals Usa Llc	d04b397c-1608-4fd9-be28-ef7285d6a996	2024-12-20	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	91575333-5268-5d8f-e053-2a95a90a7a89	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Max Strength Antibiotic plus pain relief	PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Pharmacy Value Alliance LLC	9767821e-054b-3bd3-e053-2a95a90a4b0e	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab843664-a1e0-6716-e053-2995a90a2063	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Bacitracin Zinc	BACITRACIN ZINC	Pharmacy Value Alliance LLC	99d789be-aa85-0917-e053-2a95a90acd13	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab863d90-1a8f-3c1f-e053-2a95a90aa0a7	2024-12-20	Warnings	Exact identifier application number: M004
Family Wellness First Aid Antibiotic	FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA, LLC	9157681a-3ed1-096e-e053-2a95a90a05e3	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Original	FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B	Trifecta Pharmaceuticals USA LLC.	915759af-0d4f-6a87-e053-2a95a90acbd6	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Pain Scar Itch	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Trifecta Pharmaceutical USA LLC	9e507ec5-310d-3a21-e053-2a95a90a15a6	2024-12-18	Warnings	Exact identifier application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1046313	benzocaine 6 % / ethanol 60 % Medicated Pad	PSN	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
797544	isopropyl alcohol 70 % Medicated Pad	PSN	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1046313	benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated Pad	SCD	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 0.13 % Topical Cloth	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 0.13 % Topical Swab	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
1046313	benzocaine 6 % / ethanol 60 % Topical Swab	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
797544	isopropyl alcohol 70 % Medicated Pad	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
797544	isopropyl alcohol 70 % Topical Cloth	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7
797544	isopropyl alcohol 70 % Topical Swab	SY	3b5d07c6-bda2-4bc7-89b8-88280d11ed74	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50814-002-01	50814000201	0.45 g in 1 POUCH	0.45 g					Historical
50814-009-01	50814000901	0.9 g in 1 PACKAGE	0.9 g					Historical
50814-039-01	50814003901	1 in 1 BOX						Historical
50814-041-02	50814004102	0.53 mL in 1 POUCH	0.53 ml					Historical
50814-042-01	50814004201	1 KIT in 1 KIT (50814-042-01) * 2 POUCH in 1 KIT / .53 mL in 1 POUCH (50814-041-02) * 2 BAG in 1 KIT / .9 g in 1 BAG (50814-007-01) * 2 PACKAGE in 1 KIT / .9 g in 1 PACKAGE (50814-009-01) * 2 BOX in 1 KIT / 1 POUCH in 1 BOX (50814-002-01) / .45 g in 1 POUCH * 2 BOX in 1 KIT / 1 BAG in 1 BOX (50814-039-01) / .45 g in 1 BAG	1 kit	2018-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FAK Care4 Bus and School Yellow Kit ORM-D	GFA Production (Xiamen) Co., Ltd. \| Lights Medical Manufacture Co., Ltd.	2025-01-22	HUMAN OTC DRUG LABEL	7