FDA.reportPublic FDA data

Sore Relief

Manufacturer
ridge properties llc
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:08:28

Label at a glance#

ProductSore Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

dosage and administrationdosage and administration

INACTIVE INGREDIENT SECTION

inactive ingredient sectioninactive ingredient section

INDICATIONS & USAGE SECTION

indications and usageindications and usage

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

OTC - ACTIVE INGREDIENT SECTION

active ingredientsactive ingredients

OTC - PURPOSE SECTION

purposepurpose

WARNINGS SECTION

warnings sectionwarnings section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panelprincipal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN3
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD3
1010077lidocaine hydrochloride 4 % Topical GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
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
69804-077-142021-07-23C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-152021-07-23C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-162021-07-23C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-142020-02-08C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-152020-02-08C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-162020-02-08C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-142020-01-31C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-152020-01-31C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-162020-01-31C16284748780-19d75b9d0-41e9-f424-e053-dadaa90a57ce5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69804-077-14Sore Relief28500 mg in 1 BOTTLE, DISPENSINGGEL285003
69804-077-15Sore Relief56700 mg in 1 BOTTLE, DISPENSINGGEL567003
69804-077-16Sore Relief113400 mg in 1 BOTTLE, DISPENSINGGEL1134003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69804-077SORE RELIEF (LIDOCAINE HCL) GEL [RIDGE PROPERTIES LLC]3Legacy NDC, 3 package rows20200429_5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69804-07769804-077-14, 69804-077-15, 69804-077-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
PIPER METHYSTICUM ROOTBOW48C81XPIACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
COPAIBA OIL64VX45Y68NIACT
BENTONITEA3N5ZCN45CIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT

Source Document#

Source XML · Source PDF

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
a45dfdb4-2c47-3409-e053-2995a90ae8d35df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa2020-06-19WarningsExact identifier
spl id: a45dfdb4-2c47-3409-e053-2995a90ae8d3
spl set id: 5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa

Reported adverse events (FAERS/openFDA)#

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