FDA.reportPublic FDA data

Dologesic Roll-On

Manufacturer
Llorens Pharmaceutical International Division, Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:30:23

Label at a glance#

ProductDologesic Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine HCL, USP 4% 

OTC - PURPOSE SECTION

Purpose

Topical Anesthetic

INDICATIONS & USAGE SECTION

Use

Temporarily relieves minor pains

WARNINGS SECTION

Warnings

For external use only

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use.

Stop use and ask doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children over 12 years of age
  • Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 application in a 24 hour period.
  • Not for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

Inactive ingredients

camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.

OTC - QUESTIONS SECTION

Questions

Llorens Pharmaceutical International Division, Inc.

Miami Fl 33147

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DologesicRollOnDologesicRollOn

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN9
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD9
1987647lidocaine hydrochloride 4 % Topical SolutionSY9

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
54859-513-022020-12-23C16284748780-19d75b9d0-7d59-f424-e053-dadaa90a57ceDologesic Roll-On 513
54859-513-022020-01-31C16284748780-19d75b9d0-7d59-f424-e053-dadaa90a57ceDologesic Roll-On 513

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-513-02Dologesic Roll-On60 mL in 1 BOTTLELIQUID609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-513-02ML - Milliliter54859-5130f5660c3-30e0-419e-9de1-7e92b828395812023-08-08

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54859-51354859-513-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Dologesic Roll-OnLIDOCAINE HCLLlorens Pharmaceutical International Division, Inc.81546810-85a8-45fe-b9e6-cdd02cc4c0802025-12-31WarningsExact identifier
ndc (package): 54859-513-02
ndc (product): 54859-513
ndc11 (package): 54859051302
spl id: 47467d33-95dd-c5ae-e063-6294a90a5b84
spl set id: 81546810-85a8-45fe-b9e6-cdd02cc4c080

Reported adverse events (FAERS/openFDA)#

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