Pain Relieving Roll-On

Product NDC
61010-1550
11-digit product format
610101550
Labeler code
61010
Product ID
61010-1550_10a91ff8-4d59-15dd-e063-6394a90a3aad
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, unspecified form
Dosage form
GEL
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-07
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
7 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relieving Roll-On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311509Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80118260-9c88-402d-9a90-ecfe62b4b54fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-1550-12024-02-13C16284748780-11030e365-516c-111a-e063-dadaa90a10e261010-1550-1, Pain Relieving Roll-on
61010-1550-12024-01-30C16284748780-11030e365-516c-111a-e063-dadaa90a10e261010-1550-1, Pain Relieving Roll-on

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-1550-1Pain Relieving Roll-On88 mL in 1 BOTTLEGEL882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-1550PAIN RELIEVING ROLL-ON (MENTHOL, UNSPECIFIED FORM) GEL [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_80118260-9c88-402d-9a90-ecfe62b4b54f.zip

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 86 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone with AloeHYDROCORTISONEAmerisourceBergen0c544792-63d9-400c-9888-207c44fdc75e2025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy HydrocortisoneHYDROCORTISONEAmerisourceBergen58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf2025-07-08WarningsExact identifier
application number: M017
Publix HydroHYDROCORTISONEPublix Super Markets Inc29296b0f-0eed-4bb9-8727-c25c2bcf9fd62025-07-08WarningsExact identifier
application number: M017
Publix hydro plusHYDROCORTISONEPublix Super Markets Inca00d82c1-6b09-424a-be78-2603eee3fb9d2025-07-08WarningsExact identifier
application number: M017
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017
Neutrogena Sun Rescue After Sun Medicated ReliefCAMPHOR (SYNTHETIC)Kenvue Brands LLCc95c5b64-b90f-1143-e053-2a95a90aa03c2025-07-07WarningsExact identifier
application number: M017
sunmark HydrocortisoneHYDROCORTISONEStrategic Sourcing Services LLC210079e9-3d2f-4489-b468-b96b145034ed2025-07-07WarningsExact identifier
application number: M017
Relief GelLIDOCAINE HCLGood Clean Love, Inc.e5fa2265-ccb7-750c-e053-2995a90aa51e2025-07-07WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONESun Pharmaceutical Industries, Inc.09ac2749-a60f-4039-8c80-a0d2eaf50c342025-07-07WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.2ada9ec2-1c28-4da2-8639-07b3193ffb322025-07-03WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESun Pharmaceutical Industries, Inc.caa2fd64-e262-4d7c-ad8a-69f506feba8c2025-07-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311509menthol 7 % Topical GelPSN80118260-9c88-402d-9a90-ecfe62b4b54f2
311509menthol 0.07 MG/MG Topical GelSCD80118260-9c88-402d-9a90-ecfe62b4b54f2
311509menthol 7 % Topical GelSY80118260-9c88-402d-9a90-ecfe62b4b54f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-1550-16101015500188 mL in 1 BOTTLE (61010-1550-1) 88 ml2019-10-070000-00-00NoNoCurrent