FDA.reportPublic FDA data

INSECT STING RELIEF

Product NDC
50814-041
Requested package NDC
50814-041-02
11-digit product format
508140041
Labeler code
50814
Product ID
50814-041_ecf8f4d9-b6c2-3bce-e053-2995a90a66a5
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE, ALCOHOL
Dosage form
SWAB
Route
TOPICAL
Labeler
GFA Production (Xiamen) Co., Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-06-29
Marketing end
0000-00-00
Substance
ALCOHOL; BENZOCAINE
Active strength
600 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50814-04150814-041-02DDiscontinued by firm2026-09-14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
50814-041-02FAK Care4 Bus and School Yellow ORM D0.53 mL in 1 POUCHSWAB0.53 mL600 mg in 1mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-041FAK 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
50814-041INSECT STING RELIEF (BENZOCAINE, ALCOHOL) SWAB [GFA PRODUCTION (XIAMEN) CO., LTD.]5Legacy NDC20241011_925e1d4c-6008-08da-e053-2995a90a6133.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
ndc (package): 50814-041-02
ndc11 (package): 50814004102

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
50814-041-0250814004102.53 mL in 1 POUCH (50814-041-02) 2018-06-290000-00-00NoNoCurrent