Home NDC 42637-803-01 Olbas Lozenges
Product NDC 42637-803
Requested package NDC 42637-803-01
11-digit product format 426370803
Labeler code 42637
Product ID 42637-803_69351113-bd7b-d97d-e053-2a91aa0a985b
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LOZENGE
Route ORAL
Labeler Jakemans (Confectioners) Limited
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-04-05
Marketing end 0000-00-00
Substance MENTHOL
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 42637-803 42637-803-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42637-803 OLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED] 8 Legacy NDC 20231102_5816379f-f90c-429f-b00a-dfe5aaca253e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42637-803-01 42637080301 24 LOZENGE in 1 BOX (42637-803-01) 24 lozenge 2010-04-05 0000-00-00 No No Current