FDA.reportPublic FDA data

First Aid Antibiotic

Product NDC
50814-007
11-digit product format
508140007
Labeler code
50814
Product ID
50814-007_82ccece0-7013-a6d8-e053-2991aa0a4a9c
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
GFA Production (Xiamen) Co., Ltd.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [iU]/g; mg/g; [iU]/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-007FAK 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.]10Legacy NDC20250102_64c767ba-7788-1d31-e053-2991aa0a48da.zip
50814-007FAK 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.]7Legacy NDC20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip
50814-007FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Legacy NDC20250123_9f970b62-310b-42a4-883a-43641ccb8516.zip

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50814-007-0150814000701.9 g in 1 BAG (50814-007-01) 2016-07-010000-00-00NoNoCurrent