FDA.reportPublic FDA data

Diabetic First Aid Gel

Product NDC
71521-390
11-digit product format
715210390
Labeler code
71521
Product ID
71521-390_4df3c46f-fde3-1c53-e063-6294a90ab613
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Lavior Pharma Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diabetic First Aid Gel
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui2535510

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
71521-390-152026-01-29C16284748780-149896155-ba3c-586f-e063-e6dba90add90bda875e6-06bd-930f-e053-2995a90ab197
71521-390-302026-01-29C16284748780-149896155-ba3c-586f-e063-e6dba90add90bda875e6-06bd-930f-e053-2995a90ab197
71521-390-502026-01-29C16284748780-149896155-ba3c-586f-e063-e6dba90add90bda875e6-06bd-930f-e053-2995a90ab197

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71521-390-15Diabetic First Aid Gel15 g in 1 TUBEGEL1510
71521-390-30Diabetic First Aid Gel30 g in 1 TUBEGEL3010
71521-390-50Diabetic First Aid Gel50 g in 1 BOTTLE, PUMPGEL5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71521-390-30ML - Milliliter71521-390b8ae663e-c92f-40b9-b96d-0924222d6a2112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-390DIABETIC FIRST AID GEL (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [LAVIOR PHARMA INC.]9Current NDC, Legacy NDC, 3 package rows20241024_bda875e6-06bd-930f-e053-2995a90ab197.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2535510benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical GelPSNbda875e6-06bd-930f-e053-2995a90ab19710
2535510benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.005 MG/MG Topical GelSCDbda875e6-06bd-930f-e053-2995a90ab19710
2535510benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical GelSYbda875e6-06bd-930f-e053-2995a90ab19710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71521-390-157152103901515 g in 1 TUBE (71521-390-15) 15 g2022-03-170000-00-00NoNoCurrent
71521-390-307152103903030 g in 1 TUBE (71521-390-30) 30 g2023-04-01NoNoHistorical
71521-390-507152103905050 g in 1 BOTTLE, PUMP (71521-390-50) 50 g2021-03-310000-00-00NoNoCurrent