FDA.reportPublic FDA data

Orasep

Product NDC
54859-503
11-digit product format
548590503
Labeler code
54859
Product ID
54859-503_e68250f2-c90d-4555-8d98-55b5906df24b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Menthol, Cetylpyridinium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Llorens Pharmaceutical International Division
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-04-01
Marketing end
0000-00-00
Substance
BENZOCAINE; MENTHOL; CETYLPYRIDINIUM CHLORIDE
Active strength
2 mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct54859-503IInactivated by FDA2026-10-05
excluded packagepackage54859-50354859-503-01IInactivated by FDA2026-10-05

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54859-503-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54859-503-019bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-503-012020-12-23C16284748780-19d75b9cf-cecf-f424-e053-dadaa90a57ceLlorens- Orasep Liquid 503
54859-503-012020-01-31C16284748780-19d75b9cf-cecf-f424-e053-dadaa90a57ceLlorens- Orasep Liquid 503

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-503-01Orasep30 mL in 1 BOTTLELIQUID306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-503-01ML - Milliliter54859-503d583a43f-ce26-4aee-80ce-76af46ca536712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5ORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5ORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3ORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
MENTHOLACTIVE MOIETYL7T10EIP3AORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2
WATERINACTIVE INGREDIENT059QF0KO0RORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-503ORASEP (BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5Legacy NDC, 1 package rows20241222_ed70911b-9da8-4e1d-97fa-66b18d28516a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362704benzocaine 2 % / menthol 0.5 % / cetylpyridinium chloride 0.1 % Mucous Membrane Topical SolutionPSNed70911b-9da8-4e1d-97fa-66b18d28516a6
1547767Orasep (2 % / 0.1 % / 0.5 % ) Mucous Membrane Topical Solution, Reformulated Dec 2013PSNed70911b-9da8-4e1d-97fa-66b18d28516a6
1547767benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucous Membrane Topical Solution [Orasep Reformulated Dec 2013]SBDed70911b-9da8-4e1d-97fa-66b18d28516a6
1362704benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucous Membrane Topical SolutionSCDed70911b-9da8-4e1d-97fa-66b18d28516a6
1362704benzocaine 2 % / cetylpyridinium chloride 0.1 % / menthol 0.5 % Mucous Membrane Topical SolutionSYed70911b-9da8-4e1d-97fa-66b18d28516a6
1547767benzocaine 2 % / cetylpyridinium chloride 0.1 % / menthol 0.5 % Mucous Membrane Topical Solution [Orasep Reformulated Dec 2013]SYed70911b-9da8-4e1d-97fa-66b18d28516a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-503-015485905030130 mL in 1 BOTTLE (54859-503-01) 30 ml2010-04-010000-00-00NoNoCurrent