FDA.reportPublic FDA data

CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:49

Label at a glance#

ProductCIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%
Active ingredientIBUPROFEN, CIMETIDINE, SALICYLIC ACID
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

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Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 1047-2 CIMETIDINE USP 5% / IBUPROFEN USP 2% / SALICYLIC ACID USP 17%. Gel 30gm.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CIMETIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1047-22021-01-29C16284748780-1ba0f9c33-452d-a910-e053-dadaa90a0b85CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1047-2CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1047CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190518_891a69a7-e004-c8c5-e053-2995a90ab49e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-104772934-1047-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
CIMETIDINE80061L1WGDACTIB
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

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
891a69a7-e005-c8c5-e053-2995a90ab49e891a69a7-e004-c8c5-e053-2995a90ab49e2019-05-17Adverse reactionsExact identifier
spl id: 891a69a7-e005-c8c5-e053-2995a90ab49e
spl set id: 891a69a7-e004-c8c5-e053-2995a90ab49e

Reported adverse events (FAERS/openFDA)#

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