FDA.reportPublic FDA data

Medi-First Burn with Lidocaine

Product NDC
47682-984
11-digit product format
476820984
Labeler code
47682
Product ID
47682-984_3e5d69c8-f6d1-40cd-e063-6294a90a7b14
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Unifirst First Aid Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-01
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
Medi-First Burn with Lidocaine
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
UniiV13007Z41A, F5UM2KM3W7
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
47682-984-73Medi-First Burn with Lidocaine25 in 1 BOXCREAM253
47682-984-73Medi-First Burn with Lidocaine0.9 g in 1 PACKETCREAM0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-984MEDI-FIRST PLUS BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM MEDI-FIRST BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [UNIFIRST FIRST AID CORPORATION]2Current NDC, 2 package rows20241120_f2b7e1c4-6369-9efa-e053-2a95a90a8212.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNf2b7e1c4-6369-9efa-e053-2a95a90a82123
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDf2b7e1c4-6369-9efa-e053-2a95a90a82123
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYf2b7e1c4-6369-9efa-e053-2a95a90a82123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
47682-984-734768209847325 PACKET in 1 BOX (47682-984-73) / .9 g in 1 PACKET25 packet2023-04-01NoNoCurrent