FDA.reportPublic FDA data

First Aid and Burn

Product NDC
50332-0091
11-digit product format
503320091
Labeler code
50332
Product ID
50332-0091_98a02c61-1ac2-4788-93e9-a3b574960c9e
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
HART Health
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-18
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE
Active strength
.13; .5 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
First Aid and Burn
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
LIDOCAINE.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012100Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07d447f1-469c-4e34-b807-ede9a449e6abAvailable 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
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
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

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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
application number: M
NUTRALOXCALCIUM CARBONATEHART Health3941b84e-3b4b-46eb-851b-979bac1ae9972025-12-31WarningsExact identifier
application number: M
PVP IodinePOVIDONE-IODINEHART Health06b085dd-934d-40e9-aa0d-2dd9cdccd5352025-12-31WarningsExact identifier
application number: M
WOUND WIPESBENZALKONIUM CHLORIDEHART Health4942195e-2941-4111-8ab7-2891c316bd272025-12-31WarningsExact identifier
application number: M
MG DermaGel 62ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.e6b2cc57-11a6-4808-a30f-8118a8de9fc62025-12-29WarningsExact identifier
application number: M
MG FoamSanBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.c5311836-674a-400b-a0d3-92f959d926822025-12-29WarningsExact identifier
application number: M
CETAFEN EXTRAACETAMINOPHENHART Health38db0b09-37f8-4fed-903e-81e89486b39b2025-12-24WarningsExact identifier
application number: M
CETAFENACETAMINOPHENHART Healthc1162bab-377d-4e17-9417-ccd20d29148b2025-12-24WarningsExact identifier
application number: M
CETAFEN COUGH and COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,HART Health44da0d8c-4a12-4122-99da-781e2809e1a82025-12-24WarningsExact identifier
application number: M
Adult Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.4522f745-b88d-4021-a5dc-0161f1967dc92025-12-24WarningsExact identifier
application number: M
MG DermaFoamBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.4a43a605-f333-4c76-a476-476a9cc2e13a2025-12-23WarningsExact identifier
application number: M
MG DermaGel 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.56ac723b-3ede-4c94-bf4a-0572a7b42b592025-12-23WarningsExact identifier
application number: M
MG DermaSan 72ISOPROPYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.cccdefbc-09ef-417f-9b7a-1b254ae6e4382025-12-23WarningsExact identifier
application number: M
MG FoamSan 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.11fc23dd-80e1-4df1-8c19-f759ecb34f1a2025-12-23WarningsExact identifier
application number: M
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
application number: M
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
application number: M
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
application number: M
Antibacterial Liquid HandBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.ea0a5970-e95f-4090-bbe3-7df9e04393b52025-12-23WarningsExact identifier
application number: M
MG DermaCleanN/AMorgan Gallacher Inc.ed3d983e-0a6e-4de4-832a-0020f77110112025-12-23WarningsExact identifier
application number: M
MG DermaSanN/AMorgan Gallacher Inc.d4c0de39-8570-4a05-a5e3-3752545ed95f2025-12-23WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN07d447f1-469c-4e34-b807-ede9a449e6ab3
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD07d447f1-469c-4e34-b807-ede9a449e6ab3
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY07d447f1-469c-4e34-b807-ede9a449e6ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0091-1503320091016 PACKET in 1 BOX, UNIT-DOSE (50332-0091-1) / .9 g in 1 PACKET6 packet2025-09-18NoNoCurrent
50332-0091-25033200910225 PACKET in 1 BOX, UNIT-DOSE (50332-0091-2) / .9 g in 1 PACKET25 packet2025-09-18NoNoCurrent
50332-0091-450332009104144 PACKET in 1 BOX, UNIT-DOSE (50332-0091-4) / .9 g in 1 PACKET144 packet2025-09-18NoNoCurrent
50332-0091-65033200910610 PACKET in 1 BOX, UNIT-DOSE (50332-0091-6) / .9 g in 1 PACKET10 packet2025-09-18NoNoCurrent
50332-0091-9503320091092000 PACKET in 1 BOX, UNIT-DOSE (50332-0091-9) / .9 g in 1 PACKET2000 packet2025-09-18NoNoCurrent