FDA.reportPublic FDA data

CIMETIDINE 10% / LIDOCAINE 5% / SALICYLIC ACID 40%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-04-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:29

Label at a glance#

ProductCIMETIDINE 10% / LIDOCAINE 5% / SALICYLIC ACID 40%
Active ingredientSALICYLIC ACID, LIDOCAINE, CIMETIDINE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for Use

INSTRUCTIONS FOR USE SECTION

cc

Sincerus Florida, LLC adverse reactions.

ADVERSE REACTIONS SECTION

ss

Active, inactive

COMPONENTS

dd

NDC 72934-2046-2 CIMETIDINE USP 10% / LIDOCAINE USP 5% / SALICYLIC ACID USP 40% Cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ff

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-2046-22021-01-29C16284748780-1ba0f9c33-3aad-a910-e053-dadaa90a0b85CIMETIDINE 10% / LIDOCAINE 5% / SALICYLIC ACID 40%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2046-2CIMETIDINE 10% / LIDOCAINE 5% / SALICYLIC ACID 40%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2046CIMETIDINE 10% / LIDOCAINE 5% / SALICYLIC ACID 40% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_874cd0d1-8711-225c-e053-2995a90af24b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-2046-2GM - Gram72934-2046fc8e6249-6a7e-484c-801d-7042e139a9ba12020-03-10

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
72934-204672934-2046-2

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
SALICYLIC ACIDO414PZ4LPZACTIB
LIDOCAINE98PI200987ACTIB
CIMETIDINE80061L1WGDACTIB

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
874cd0d1-8712-225c-e053-2995a90af24b874cd0d1-8711-225c-e053-2995a90af24b2019-04-24Adverse reactionsExact identifier
spl id: 874cd0d1-8712-225c-e053-2995a90af24b
spl set id: 874cd0d1-8711-225c-e053-2995a90af24b

Reported adverse events (FAERS/openFDA)#

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