FDA.reportPublic FDA data

Be Smart Get Prepared Burn Cream

Product NDC
55550-521
11-digit product format
555500521
Labeler code
55550
Product ID
55550-521_bbda118e-c339-4e2a-bb88-6e2aec6d3209
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride Anhydrous
Dosage form
CREAM
Route
TOPICAL
Labeler
Total Resources International, Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-16
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
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

Additional Listing Data#

Finished product
Yes
Brand name base
Be Smart Get Prepared Burn Cream
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, EC2CNF7XFP
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
55550-521-01Be Smart Get Prepared Burn Cream0.9 g in 1 POUCHCREAM0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-521BE SMART GET PREPARED BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS) CREAM [TOTAL RESOURCES INTERNATIONAL, INC]1Current NDC, 1 package rows20240823_eacb5138-4af8-4550-b883-5603ad96ed7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNeacb5138-4af8-4550-b883-5603ad96ed7d1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDeacb5138-4af8-4550-b883-5603ad96ed7d1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYeacb5138-4af8-4550-b883-5603ad96ed7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55550-521-0155550052101.9 g in 1 POUCH (55550-521-01) 2024-08-16NoNoCurrent