FDA.reportPublic FDA data

First Aid Antiseptic Pain Relieving

Product NDC
50814-009
Requested package NDC
50814-009-01
11-digit product format
508140009
Labeler code
50814
Product ID
50814-009_cb67bf50-e2b6-8fc2-e053-2a95a90a05c6
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
GFA Production (Xiamen) Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage50814-00950814-009-01DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

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

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50814-00950814-009-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
50814-009-01FAK Care4 Bus and School Yellow ORM D0.9 g in 1 PACKAGECREAM0.9 g1.3 mg in 1g7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-009FAK 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
50814-009FIRST AID ANTISEPTIC PAIN RELIEVING (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [GFA PRODUCTION (XIAMEN) CO., LTD.]10Legacy NDC20250502_f61ee175-440d-4234-a181-675ba9ddb03a.zip
50814-009FAK 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

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): 50814-009-01
ndc11 (package): 50814000901

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
50814-009-0150814000901.9 g in 1 PACKAGE (50814-009-01) 2016-07-010000-00-00NoNoCurrent