Home NDC 52261-5800 Botanimedix OnychoRX Antifungal Nail Gel
Product NDC 52261-5800
11-digit product format 522615800
Labeler code 52261
Product ID 52261-5800_0c4206d2-bb4d-4adc-9546-67081c2f47f9
Type HUMAN OTC DRUG
Nonproprietary name Undecylenic Acid
Dosage form GEL
Route TOPICAL
Labeler Cosco International, Inc.
Application part333C
Marketing category OTC MONOGRAPH FINAL
Marketing start 2020-01-01
Marketing end 0000-00-00
Substance UNDECYLENIC ACID
Active strength 0 kg/kg
NDC exclude flag No
Listing certified through 2021-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52261-5800-0 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52261-5800-0 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52261-5800-0 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52261-5800-0 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52261-5800-0 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52261-5800-0 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52261-5800-0 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52261-5800-0 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52261-5800-0 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 52261-5800-0 Botanimedix OnychoRX Antifungal Nail Gel 1 in 1 CARTON GEL 1 3 52261-5800-1 Botanimedix OnychoRX Antifungal Nail Gel 0.002 kg in 1 BOTTLE, WITH APPLICATOR GEL 0.002 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52261-5800 BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL (UNDECYLENIC ACID) GEL [COSCO INTERNATIONAL, INC.] 3 Legacy NDC, 2 package rows 20200327_16e8a074-905e-41b5-bb46-c7bb3e914f7a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52261-5800-0 52261580000 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52261-5800-0) > .002 kg in 1 BOTTLE, WITH APPLICATOR (52261-5800-1) 2020-01-01 0000-00-00 No No Current 52261-5800-1 52261580001 0.002 kg in 1 BOTTLE, WITH APPLICATOR 0.002 kg Historical