Home NDC 55758-300-01 OptimV Anti-Itch
Product NDC 55758-300
Requested package NDC 55758-300-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55758-300 55758-300-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-300 OPTIMV ANTI-ITCH MAXIMUM STRENGTH (BENZOCAINE, RESORCINOL) CREAM [PHARMADEL LLC] 4 Legacy NDC 20241120_e064940f-83d7-85b6-e053-2995a90aec92.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55758-300-01 55758030001 1 TUBE in 1 CARTON (55758-300-01) > 28 g in 1 TUBE 1 tube 2022-06-01 0000-00-00 No No Current