FDA.reportPublic FDA data

Trimo-San

Product NDC
0295-5030
11-digit product format
002955030
Labeler code
0295
Product ID
0295-5030_9249c02c-05b5-5fb2-e053-2a95a90a2b2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxyquinoline Sulfate and Sodium Lauryl Sulfate
Dosage form
JELLY
Route
VAGINAL
Labeler
Denison Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-09-16
Marketing end
0000-00-00
Substance
OXYQUINOLINE SULFATE; SODIUM LAURYL SULFATE
Active strength
0 mg/g; mg/g
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 · 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
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct0295-5030YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0295-50300295-5030-18YUnknown FDA exclusion code: Yexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0295-5030-18Trimo-San113.4 g in 1 TUBEJELLY113.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0295-5030TRIMO-SAN (OXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATE) JELLY [DENISON PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20190917_9249da53-e62c-bb0c-e053-2995a90a8d5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999638oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % Vaginal GelPSN9249da53-e62c-bb0c-e053-2995a90a8d5a1
999640TRIMO-SAN 0.025 % / 0.01 % Vaginal GelPSN9249da53-e62c-bb0c-e053-2995a90a8d5a1
999640oxyquinoline sulfate 0.00025 MG/MG / sodium dodecyl sulfate 0.0001 MG/MG Vaginal Gel [Trimo San]SBD9249da53-e62c-bb0c-e053-2995a90a8d5a1
999638oxyquinoline sulfate 0.00025 MG/MG / sodium dodecyl sulfate 0.0001 MG/MG Vaginal GelSCD9249da53-e62c-bb0c-e053-2995a90a8d5a1
999638oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % Vaginal GelSY9249da53-e62c-bb0c-e053-2995a90a8d5a1
999640Trimo San (oxyquinoline sulfate 0.025 % / sodium lauryl sulfate 0.01 % ) Vaginal GelSY9249da53-e62c-bb0c-e053-2995a90a8d5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0295-5030-1800295503018113.4 g in 1 TUBE113.4 gHistorical