OptimV Anti-Itch

Product NDC
55758-300
11-digit product format
557580300
Labeler code
55758
Product ID
55758-300_e0f46a69-5cea-6eab-e053-2a95a90a8435
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Resorcinol
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmadel
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-06-01
Marketing end
0000-00-00
Substance
BENZOCAINE; RESORCINOL
Active strength
20 g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-300OPTIMV ANTI-ITCH MAXIMUM STRENGTH (BENZOCAINE, RESORCINOL) CREAM [PHARMADEL LLC]4Legacy NDC20241120_e064940f-83d7-85b6-e053-2995a90aec92.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-300-01557580300011 TUBE in 1 CARTON (55758-300-01) > 28 g in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent
55758-300-07557580300071 TUBE in 1 CARTON (55758-300-07) > 20 g in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent