Home NDC 53145-019 Hongocura Pinceladas
Product NDC 53145-019
11-digit product format 531450019
Labeler code 53145
Product ID 53145-019_3a894902-8af9-0d7b-e063-6294a90a81a9
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid
Dosage form LIQUID
Route TOPICAL
Labeler Menper Distributors, Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-21
Substance UNDECYLENIC ACID
Active strength 200 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 53145-019 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-019 53145-019-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Hongocura Pinceladas
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UNDECYLENIC ACID 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1437295 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-019-01 Hongocura Pinceladas 1 in 1 CARTON LIQUID 1 6 53145-019-01 Hongocura Pinceladas 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 6
DailyMed Socrata Ingredients# 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 40 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-019-01 53145001901 1 BOTTLE, WITH APPLICATOR in 1 CARTON (53145-019-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR 2012-02-21 0000-00-00 No No Current