FDA.reportPublic FDA data

Burn Cream

Product NDC
69396-146
11-digit product format
693960146
Labeler code
69396
Product ID
69396-146_130896d1-aaca-5932-e063-6394a90aba9f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine HCI
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-06
Substance
LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
.005; .0013 g/g; g/g
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

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
Burn Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE.005 g/g
BENZALKONIUM CHLORIDE.0013 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
F5UM2KM3W7Internal 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
1308ce91-2858-310a-e063-6394a90a6810Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-146-10Burn Cream0.9 g in 1 PACKETCREAM0.91
69396-146-10Burn Cream10 in 1 CARTONCREAM101
69396-146-25Burn Cream0.9 g in 1 PACKETCREAM0.91
69396-146-25Burn Cream25 in 1 CARTONCREAM251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-146BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]1Current NDC, 4 package rows20240308_1308ce91-2858-310a-e063-6394a90a6810.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 30 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLTrifecta Pharmaceuticals USA0ba469a8-53f3-eb8e-e063-6294a90a1efc2026-03-04WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCa6d2068f-705d-4341-b1c8-81e1b563ab9a2026-03-04WarningsExact identifier
application number: M003
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
application number: M003
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
application number: M003
Medicated Apricot ScrubSALICYLIC ACIDOld East Main Co.7c9c430b-30d8-4642-85bd-d028a9aa748a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsExact identifier
application number: M003
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEOld East Main Co.3c823b47-2ab7-4002-9b6f-abf0a3176b442026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
American Red Cross 6oz, 3% Hydrogen PeroxideAMERICAN RED CROSS 6 OZ, 3% HYDROGEN PEROXIDE SPRAYMY IMPORTS USA LLC29299c46-a929-0d92-e063-6294a90a42182026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEChain Drug Marketing Association31e7063e-0ba1-434f-b404-0ec42df634a32026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
Iodine TinctureIODINE TINCTUREThe Kroger Co.c70a718f-d51a-455a-9785-ab41c1b1f8b02026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
MedPride SterileBENZALKONIUM CHLORIDEShield Line LLC02f63d50-e4ff-49b6-9f8c-fddceefe65f32026-02-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalmart Inc.c8fa5ed3-0497-4a23-934b-c72ff02c94ae2026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFI4eee73dd-039e-44a5-b380-21ff32efee222026-02-26Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN1308ce91-2858-310a-e063-6394a90a68101
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD1308ce91-2858-310a-e063-6394a90a68101
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY1308ce91-2858-310a-e063-6394a90a68101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-146-106939601461010 PACKET in 1 CARTON (69396-146-10) / .9 g in 1 PACKET10 packet2024-03-06NoNoCurrent
69396-146-256939601462525 PACKET in 1 CARTON (69396-146-25) / .9 g in 1 PACKET25 packet2024-03-06NoNoCurrent