FDA.reportPublic FDA data

First Aid and Burn

Product NDC
50332-0037
Requested package NDC
50332-0037-4
11-digit product format
503320037
Labeler code
50332
Product ID
50332-0037_94349edb-f001-44cb-82af-6b44cb352d84
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
2000-07-14
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
2026-12-31
Current FDA listing
Yes

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 · 3 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
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50332-003750332-0037-4IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50332-003750332-0037-4IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50332-003750332-0037-4IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
First Aid and Burn
Listing expiration
2026-12-31

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
f5746bba-9d7f-4691-b466-14985473bf14Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50332-0037-12024-02-16FIRST AID & BURN CREAM
50332-0037-22024-02-16FIRST AID & BURN CREAM
50332-0037-42024-02-16FIRST AID & BURN CREAM
50332-0037-62024-02-16FIRST AID & BURN CREAM
50332-0037-12024-01-30FIRST AID & BURN CREAM
50332-0037-22024-01-30FIRST AID & BURN CREAM
50332-0037-42024-01-30FIRST AID & BURN CREAM
50332-0037-62024-01-30FIRST AID & BURN CREAM
50332-0037-12022-11-28FIRST AID & BURN CREAM
50332-0037-22022-11-28FIRST AID & BURN CREAM
50332-0037-42022-11-28FIRST AID & BURN CREAM
50332-0037-62022-11-28FIRST AID & BURN CREAM
50332-0037-12022-01-28FIRST AID & BURN CREAM
50332-0037-22022-01-28FIRST AID & BURN CREAM
50332-0037-42022-01-28FIRST AID & BURN CREAM
50332-0037-62022-01-28FIRST AID & BURN CREAM

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0037FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [HART HEALTH]4Current NDC, Legacy NDC20240217_f5746bba-9d7f-4691-b466-14985473bf14.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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Original Mane n Tail Daily Control 2 in 1 Anti DandruffPYRITHIONE ZINCStraight Arrow Products Inc68ab55d6-b1a9-46c0-87f0-ec12ad3474bc2026-07-09WarningsExact identifier
application number: M
Stool Softener LaxativeDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.c1f588d0-4600-4b97-b2d3-2c08ac351e072026-06-30WarningsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.66ca7a94-378b-4476-8060-d9c6f82f57fc2026-06-12WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Health3d17aba0-220f-42c4-9e26-5c44857847cd2026-05-20Warnings, Adverse reactionsExact identifier
application number: M
IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral RichHOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc2a44a019-0cc0-439b-aaa5-37582ec5492e2026-05-14WarningsExact identifier
application number: M
THORACOLHONEY LEMON COUGH DROPSHART Healthfee9f594-c619-4d77-bb52-632078e0254e2026-04-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Health07d447f1-469c-4e34-b807-ede9a449e6ab2026-04-15WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE CREAMHART Healthc76fb030-cbb5-4773-aa52-d038cb41d0af2026-04-15WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEAmazon.com Services LLC55b0d905-fcc0-40ba-a5dd-331a27a3a2092026-04-07Warnings, Adverse reactionsExact identifier
application number: M
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
application number: M
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
application number: M
ASPIRINASPIRINHART Healtha1c73edf-861d-478b-9d3c-0eddcc6879cc2026-01-14WarningsExact identifier
application number: M
HISTAPRINDIPHENHYDRAMINENorMed38786a65-a12b-4479-b63c-b7c15410da042026-01-14WarningsExact identifier
application number: M
Blood ClottingBENZETHONIUM CHLORIDE AND LIDOCAINEHART Health21668731-8b8a-404f-80ab-962a0a9d5f632026-01-14WarningsExact identifier
application number: M
BandageBENZOCAINE AND BENZETHONIUM CHLORIDEHART Health6de57472-6dd0-43b6-8a82-fe459fa99ddb2026-01-14WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINE, ISOPROPYL ALCOHOLHART Healthc0e7d661-a9c9-4656-a516-57552848ebe82026-01-12WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLHART Health8d01b10b-7916-420e-9d44-ebd3806fe3152026-01-12WarningsExact identifier
application number: M
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNf5746bba-9d7f-4691-b466-14985473bf144
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDf5746bba-9d7f-4691-b466-14985473bf144
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYf5746bba-9d7f-4691-b466-14985473bf144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50332-0037-450332003704144 PACKET in 1 BOX, UNIT-DOSE (50332-0037-4) / .9 g in 1 PACKET144 packet2000-07-140000-00-00NoNoCurrent