FDA.reportPublic FDA data

Burn Cream

Product NDC
69396-136
11-digit product format
693960136
Labeler code
69396
Product ID
69396-136_4af5a82b-f212-7f5c-e063-6394a90a6852
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
2023-10-23
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.0013; .005 g/g; g/g
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

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Cream
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1012100

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
69396-136-10Burn Cream0.9 g in 1 PACKETCREAM0.94
69396-136-10Burn Cream10 in 1 CARTONCREAM104
69396-136-25Burn Cream0.9 g in 1 PACKETCREAM0.94
69396-136-25Burn Cream25 in 1 CARTONCREAM254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-136BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, 4 package rows20250101_087ac43c-1076-d1e2-e063-6294a90a5859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN087ac43c-1076-d1e2-e063-6294a90a58594
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD087ac43c-1076-d1e2-e063-6294a90a58594
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY087ac43c-1076-d1e2-e063-6294a90a58594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-136-106939601361010 PACKET in 1 CARTON (69396-136-10) / .9 g in 1 PACKET10 packet2023-10-23NoNoHistorical
69396-136-256939601362525 PACKET in 1 CARTON (69396-136-25) / .9 g in 1 PACKET25 packet2023-10-23NoNoHistorical