FDA.reportPublic FDA data

Burn Cream

Product NDC
55550-902
11-digit product format
555500902
Labeler code
55550
Product ID
55550-902_cbe13d07-34ab-4156-a8cd-ab055385fc6d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Total Resources International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-14
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 5 mg/g; mg/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

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g
LIDOCAINE HYDROCHLORIDE5 mg/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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-902-212025-04-21C16284748780-1d6a99b39-37ca-a426-e053-dadaa90af4c2Drug Facts
55550-902-212022-01-28C16284748780-1d6a99b39-37ca-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-902-21Burn Cream0.9 g in 1 POUCHCREAM0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-902BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [TOTAL RESOURCES INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20250507_b971cc41-fe23-4be3-9564-e46d55df1d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNb971cc41-fe23-4be3-9564-e46d55df1d683
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDb971cc41-fe23-4be3-9564-e46d55df1d683
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYb971cc41-fe23-4be3-9564-e46d55df1d683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55550-902-2155550090221.9 g in 1 POUCH (55550-902-21) 2020-01-140000-00-00NoNoCurrent