FDA.reportPublic FDA data

Olbas Lozenges

Product NDC
42637-803
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42637-803DDiscontinued by firm2026-10-12
excluded packagepackage42637-80342637-803-01DDiscontinued by firm2026-10-12

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct42637-803DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42637-80342637-803-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AOLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]6
LevomentholACTIVE MOIETYBZ1R15MTK7OLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]6
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0ROLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]6
Citric AcidINACTIVE INGREDIENT2968PHW8QPOLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]6
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662OLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]6
WaterINACTIVE INGREDIENT059QF0KO0ROLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42637-803OLBAS LOZENGES MAXIMUN STRENGTH (MENTHOL) LOZENGE [JAKEMANS (CONFECTIONERS) LIMITED]8Legacy NDC20231102_5816379f-f90c-429f-b00a-dfe5aaca253e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42637-803-014263708030124 LOZENGE in 1 BOX (42637-803-01) 24 lozenge2010-04-050000-00-00NoNoCurrent