FDA.reportPublic FDA data

Lidocaine Pain Relief Roll-On

Manufacturer
CVS Pharmacy | Pharma Nobis, LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:46

Label at a glance#

ProductLidocaine Pain Relief Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

WARNINGS SECTION

For External Use Only.

When using this product:

use only as directed

do not bandage tightly or use with a heating pad

avoid contact with eyes

do not apply to wounds or damaged skin

do not use in large quantities

partifcularly over raw surfaces or blistered areas

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE SECTION

For temporarily relief of pain and itching.

OTC - PURPOSE SECTION

Topical analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Lidocaine LBLCVS Lidocaine LBLCVS Lidocaine IFCCVS Lidocaine IFCCVS Lidocaine CartonCVS Lidocaine CartonCVGSLido.jpgCVGSLido.jpglidolido

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN6
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD6
1987647lidocaine hydrochloride 4 % Topical SolutionSY6

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-029-97Lidocaine Pain Relief Roll-On1 in 1 CARTONLIQUID16
69842-029-97Lidocaine Pain Relief Roll-On74 mL in 1 BOTTLE, WITH APPLICATORLIQUID746

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-029LIDOCAINE PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [CVS PHARMACY]6Current NDC, Legacy NDC, 2 package rows20241220_8a9757e3-0bfc-a1e2-e053-2a95a90a6da3.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-02969842-029-97

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
STEARETH-2153J3F32P58IACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CETETH-20 PHOSPHATE921FTA1500IACT

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
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%CVS Pharmacy8a9757e3-0bfc-a1e2-e053-2a95a90a6da32024-12-18WarningsExact identifier
ndc (package): 69842-029-97
ndc (product): 69842-029
ndc11 (package): 69842002997
spl id: 29941e32-b0c2-0fdd-e063-6394a90a5440
spl set id: 8a9757e3-0bfc-a1e2-e053-2a95a90a6da3

Reported adverse events (FAERS/openFDA)#

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