Home NDC 54723-007 Ombre Men overtime wipes
Product NDC 54723-007
11-digit product format 547230007
Labeler code 54723
Product ID 54723-007_40923488-6a65-15ce-e063-6294a90a6e36
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form CLOTH
Route TOPICAL
Labeler Sambria Pharmaceuticals, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-01
Substance BENZOCAINE
Active strength 7 g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ombre Men overtime wipes
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 7 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54723-007-01 Ombre Men overtime wipes 3 mL in 1 PACKET CLOTH 3 3 54723-007-01 Ombre Men overtime wipes 10 in 1 PACKAGE CLOTH 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54723-007 OMBRE MEN OVERTIME WIPES (BENZOCAINE) CLOTH [SAMBRIA PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240126_405f23ca-99c1-4db4-aba1-2fd7f93f55ee.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 109 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54723-007-01 54723000701 10 PACKET in 1 PACKAGE (54723-007-01) / 3 mL in 1 PACKET 10 packet 2022-01-01 0000-00-00 No No Current