FDA.reportPublic FDA data

Burn Cream

Product NDC
69396-105
11-digit product format
693960105
Labeler code
69396
Product ID
69396-105_4c3655ec-9140-7789-e063-6394a90addc0
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
2022-09-27
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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-105-09Burn Cream144 in 1 CARTONCREAM1444
69396-105-09Burn Cream0.9 g in 1 PACKETCREAM0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-105BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, Legacy NDC, 2 package rows20240713_e9a9fc7c-31da-ea3f-e053-2a95a90a0eab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNe9a9fc7c-31da-ea3f-e053-2a95a90a0eab4
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDe9a9fc7c-31da-ea3f-e053-2a95a90a0eab4
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYe9a9fc7c-31da-ea3f-e053-2a95a90a0eab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-105-0969396010509144 PACKET in 1 CARTON (69396-105-09) / .9 g in 1 PACKET144 packet2022-09-270000-00-00NoNoCurrent