FDA.reportPublic FDA data

Rinol-STroche

Product NDC
72988-0041
11-digit product format
729880041
Labeler code
72988
Product ID
72988-0041_25d0c38a-ec56-896f-e063-6294a90ad247
Type
HUMAN OTC DRUG
Nonproprietary name
flubiprofen
Dosage form
TROCHE
Route
ORAL
Labeler
Lydia Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-11-01
Substance
FLURBIPROFEN
Active strength
8.75 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rinol-STroche
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURBIPROFEN8.75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5GRO578KLPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
389247Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25d0bfab-3dd1-c34b-e063-6294a90ab2d1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
4de25cad-9156-ffae-eb2b-85736b333948Product name220201015
4d57173b-5512-6c00-533c-5ed2a40fc5b8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0041-1Rinol-STroche12 in 1 PACKAGETROCHE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0041RINOL-STROCHE (FLUBIPROFEN) TROCHE [LYDIA CO., LTD.]1Current NDC, 1 package rows20241102_25d0bfab-3dd1-c34b-e063-6294a90ab2d1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rinol-STrocheFLUBIPROFENLydia Co., Ltd.25d0bfab-3dd1-c34b-e063-6294a90ab2d12024-10-31WarningsExact identifier
ndc (product): 72988-0041

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
389247flurbiprofen 8.75 MG Oral LozengePSN25d0bfab-3dd1-c34b-e063-6294a90ab2d11
389247flurbiprofen 8.75 MG Oral LozengeSCD25d0bfab-3dd1-c34b-e063-6294a90ab2d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72988-0041-17298800410112 TROCHE in 1 PACKAGE (72988-0041-1) 12 troche2024-11-01NoNoCurrent