FDA.reportPublic FDA data

5 Elementum Delay Wipes

Product NDC
87203-001
11-digit product format
872030001
Labeler code
87203
Product ID
87203-001_4a14e481-bab8-8eaf-e063-6394a90afb22
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine Delay Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
MSVenturesGroup O�
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
BENZOCAINE
Active strength
70 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
5 Elementum Delay Wipes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE70 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87203-001-015 Elementum Delay Wipes10 in 1 BOXCLOTH103
87203-001-015 Elementum Delay Wipes1 g in 1 PACKAGECLOTH13
87203-001-025 Elementum Delay Wipes4 in 1 BOXCLOTH43
87203-001-025 Elementum Delay Wipes1 g in 1 PACKAGECLOTH13
87203-001-035 Elementum Delay Wipes1 g in 1 PACKAGECLOTH13
87203-001-035 Elementum Delay Wipes30 in 1 BOXCLOTH303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87203-001-018720300010110 PACKAGE in 1 BOX (87203-001-01) / 1 g in 1 PACKAGE10 package2025-12-01NoNoHistorical
87203-001-02872030001024 PACKAGE in 1 BOX (87203-001-02) / 1 g in 1 PACKAGE4 package2025-12-01NoNoHistorical
87203-001-038720300010330 PACKAGE in 1 BOX (87203-001-03) / 1 g in 1 PACKAGE30 package2025-12-01NoNoHistorical