FDA.reportPublic FDA data

MEDI-FIRST

Product NDC
71927-019
11-digit product format
719270019
Labeler code
71927
Product ID
71927-019_3ded92ae-b48f-5175-e063-6394a90ae14a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Orazen Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-29
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
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
71927-019-022025-09-03C16284748780-12cef2736-ac00-d83d-e063-dadaa90ab31f71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-032025-09-03C16284748780-12cef2736-b243-d83d-e063-dadaa90ab31f71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine
71927-019-022025-01-30C16284748780-12cef2736-ac00-d83d-e063-dadaa90ab31f71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-032025-01-30C16284748780-12cef2736-b243-d83d-e063-dadaa90ab31f71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-019-01MEDI-FIRST0.9 g in 1 POUCHCREAM0.92
71927-019-01MEDI-FIRST0.9 g in 1 POUCHCREAM0.92
71927-019-02MEDI-FIRST25 in 1 BOXCREAM252
71927-019-03MEDI-FIRST25 in 1 BOXCREAM252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-019MEDI-FIRST (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [ORAZEN INC]1Current NDC, 2 package rows20230221_f522fb0b-3d86-b228-e053-2a95a90a55e9.zip
71927-019MEDI-FIRST (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [ORAZEN INC]1Current NDC, 2 package rows20230220_f508434f-5948-7134-e053-2a95a90a03d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNf508434f-5948-7134-e053-2a95a90a03d72
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNf522fb0b-3d86-b228-e053-2a95a90a55e92
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDf508434f-5948-7134-e053-2a95a90a03d72
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDf522fb0b-3d86-b228-e053-2a95a90a55e92
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYf508434f-5948-7134-e053-2a95a90a03d72
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYf522fb0b-3d86-b228-e053-2a95a90a55e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71927-019-01719270019010.9 g in 1 POUCH0.9 gHistorical
71927-019-027192700190225 POUCH in 1 BOX (71927-019-02) / .9 g in 1 POUCH (71927-019-01) 25 pouch2025-08-29NoNoCurrent
71927-019-037192700190325 POUCH in 1 BOX (71927-019-03) / .9 g in 1 POUCH (71927-019-01) 25 pouch2025-09-03NoNoCurrent