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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55758-300DDiscontinued by firm2026-08-11
excluded packagepackage55758-30055758-300-01DDiscontinued by firm2026-08-11
excluded packagepackage55758-30055758-300-07DDiscontinued by firm2026-08-11

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55758-300-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55758-300-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55758-300-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55758-300-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55758-300-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55758-300-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55758-300-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55758-300-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55758-300-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55758-300-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55758-300-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55758-300-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55758-300-07557ba5c1ecfa…9c80585c8c6e…

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