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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Proficient Rx LP	949c5b44-ee52-4913-8872-39181d319998	2024-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	Cosette Pharmaceuticals, Inc.	69d911c2-cb89-2241-35f8-c83acfe18249	2023-12-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Cosette Pharmaceuticals, Inc.	39893365-c94f-bc83-67f6-0005d5f2aa24	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Proficient Rx LP	524d65e7-9dc6-47b0-a924-46a765fa1869	2023-12-01	Warnings	Exact identifier application number: M004
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Exact identifier application number: M004
Genuine First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production(Xiamen) Co.,Ltd	0aaee474-cf35-8b39-e063-6294a90a815c	2023-11-21	Warnings	Exact identifier application number: M004
Sheffield Bacitracin Zinc	BACITRACIN ZINC	Sheffield Pharmaceuticals LLC	0f446f48-f55d-4de7-b447-285d7a329c84	2023-11-20	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Sheffield Pharmaceuticals LLC	485a779c-017b-4064-a446-e5073c1bdb07	2023-11-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	BluePoint Laboratories	d914abe1-5e14-5673-e053-2a95a90ac91b	2023-11-17	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVERLIT GLOBAL INC.	e9157891-fc05-41a1-8a86-761a9ae56f8a	2023-11-14	Warnings	Exact identifier application number: M004
CR-371059 Tolnaftate 1%	CR-371059 TOLNAFTATE 1%	A-S Medication Solutions	bb4e4612-850c-4863-954d-7ad0500b9c05	2023-11-01	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	b44b07a0-91ff-476a-ae0a-080fa0191777	2023-10-31	Warnings	Exact identifier application number: M004
Family wellness	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FRONT PHARMACEUTICAL PLC	bd3b8146-6271-488d-bf79-0bb659123b31	2023-10-27	Warnings	Exact identifier application number: M004
Family Wellness	BACITRACIN ZINC	FRONT PHARMACEUTICAL PLC	dfc148c1-d1bb-4230-b8cf-9457b99d4e8a	2023-10-27	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