FDA.reportPublic FDA data

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
IdentifierFDA.report destination
204602Internal RxNorm lookup
797544Internal RxNorm lookup
1012100Internal RxNorm lookup
1038558Internal RxNorm lookup
1046313Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b5d07c6-bda2-4bc7-89b8-88280d11ed74Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50814-002-01FAK Care4 Bus and School Yellow ORM D0.45 g in 1 POUCHSWAB0.45 g0.13 g in 100g7
50814-002-01FAK Care4 Bus and School Yellow ORM D1 in 1 BOXSWAB0.13 g in 100g7
50814-009-01FAK Care4 Bus and School Yellow ORM D0.9 g in 1 PACKAGECREAM0.9 g1.3 mg in 1g7
50814-039-01FAK Care4 Bus and School Yellow ORM D1 in 1 BOXSWAB700 mg in 1g7
50814-039-01FAK Care4 Bus and School Yellow ORM D0.45 g in 1 BAGSWAB0.45 g700 mg in 1g7
50814-041-02FAK Care4 Bus and School Yellow ORM D0.53 mL in 1 POUCHSWAB0.53 mL600 mg in 1mL7
50814-042-01FAK Care4 Bus and School Yellow ORM D1 in 1 KITKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-042FAK 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.]7Current NDC, Legacy NDC, 7 package rows20250123_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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 0.13 % Medicated PadPSN3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1046313benzocaine 6 % / ethanol 60 % Medicated PadPSN3b5d07c6-bda2-4bc7-89b8-88280d11ed747
797544isopropyl alcohol 70 % Medicated PadPSN3b5d07c6-bda2-4bc7-89b8-88280d11ed747
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1046313benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated PadSCD3b5d07c6-bda2-4bc7-89b8-88280d11ed747
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD3b5d07c6-bda2-4bc7-89b8-88280d11ed747
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 0.13 % Topical ClothSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 0.13 % Topical SwabSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
1046313benzocaine 6 % / ethanol 60 % Topical SwabSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
797544isopropyl alcohol 70 % Medicated PadSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
797544isopropyl alcohol 70 % Topical ClothSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747
797544isopropyl alcohol 70 % Topical SwabSY3b5d07c6-bda2-4bc7-89b8-88280d11ed747

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50814-002-01508140002010.45 g in 1 POUCH0.45 gHistorical
50814-009-01508140009010.9 g in 1 PACKAGE0.9 gHistorical
50814-039-01508140039011 in 1 BOXHistorical
50814-041-02508140041020.53 mL in 1 POUCH0.53 mlHistorical
50814-042-01508140042011 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 BAG1 kit2018-02-080000-00-00NoNoCurrent