FDA.reportPublic FDA data

Pain Relief Roll On

Product NDC
79804-282
Requested package NDC
79804-282-03
11-digit product format
798040282
Labeler code
79804
Product ID
79804-282_485aeef9-80db-6a7b-e063-6394a90a1477
Type
HUMAN OTC DRUG
Nonproprietary name
Topical Analgesic
Dosage form
LIQUID
Route
TOPICAL
Labeler
Eagle Labs Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-07
Substance
MENTHOL; CAMPHOR (SYNTHETIC); CAPSAICIN
Active strength
.06; .05; .00025 g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage79804-28279804-282-03IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 Relief Roll On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.06 g/g
CAMPHOR (SYNTHETIC).05 g/g
CAPSAICIN.00025 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610122Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2380a400-062a-4a8d-a594-a2e097219044Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79804-282-032024-04-16C16284748780-11030e365-4080-111a-e063-dadaa90a10e2Pain Relief Roll On
79804-282-032024-01-30C16284748780-11030e365-4080-111a-e063-dadaa90a10e2Pain Relief Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79804-282-03Pain Relief Roll On87 g in 1 PACKAGELIQUID874

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79804-282PAIN RELIEF ROLL ON (TOPICAL ANALGESIC) LIQUID [EAGLE LABS INC]3Current NDC, Legacy NDC, 1 package rows20240418_2380a400-062a-4a8d-a594-a2e097219044.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 103 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610122camphor 5 % / capsaicin 0.025 % / menthol 6 % Topical SolutionPSN2380a400-062a-4a8d-a594-a2e0972190444
2610122camphor 50 MG/ML / capsaicin 0.25 MG/ML / menthol 60 MG/ML Topical SolutionSCD2380a400-062a-4a8d-a594-a2e0972190444
2610122camphor 5 % / capsaicin 0.025 % / menthol 6 % Topical SolutionSY2380a400-062a-4a8d-a594-a2e0972190444
2610122camphor 5 % / capsaicin 0.025 % / menthol 6 % Topical SolutionPSN26531b44-d066-d31a-e063-6394a90afc081
2610122camphor 50 MG/ML / capsaicin 0.25 MG/ML / menthol 60 MG/ML Topical SolutionSCD26531b44-d066-d31a-e063-6394a90afc081
2610122camphor 5 % / capsaicin 0.025 % / menthol 6 % Topical SolutionSY26531b44-d066-d31a-e063-6394a90afc081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79804-282-037980402820387 g in 1 PACKAGE (79804-282-03) 87 g2022-11-070000-00-00NoNoCurrent