FDA.reportPublic FDA data

Pain Relief Roll On

Product NDC
79804-282
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 · 2 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 productproduct79804-282IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
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 139 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
application number: M017
Cool n HeatCOOL N HEATNeilMed Pharmaceuticals, Inc.a24cde17-280b-8358-e053-2a95a90af67d2024-01-11WarningsExact identifier
application number: M017
NeilMed Anti-ItchANTI-ITCH SPRAYNeilMed Pharmaceuticals Inc.b3d34d9e-85d9-df4e-e053-2a95a90ac8d92024-01-11WarningsExact identifier
application number: M017
NeilMed Hot and Cold Pain ReliefPAIN RELIEF SPRAYNeilMed Pharmaceuticals Inc.b3d02111-7499-c2d4-e053-2a95a90ae1de2024-01-11WarningsExact identifier
application number: M017
Cooling Itch ReliefCOOLING ITCH RELIEFNeilMed Pharmaceuticals, Inca24bdea0-18e8-8a5e-e053-2995a90acea22024-01-11WarningsExact identifier
application number: M017
Lightning X BurnLIDOCAINENantong Health & Beyond Hygienic Products Inc.0e69a971-0c6e-6ebe-e063-6394a90a0b332024-01-08WarningsExact identifier
application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for DiabeticsLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.e07f5bf7-5a9a-468c-8c3f-2c6f0b17af292024-01-08WarningsExact identifier
application number: M017
2nd CHANCE MOBILITY Pain ReliefHISTAMINE DIHYDROCHLORIDEALPHA NUTRITION, LLC575097ac-9fc9-4391-99d1-dff9b34817e32024-01-08WarningsExact identifier
application number: M017
Tiger Balm Arthritis RubCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.80932288-4797-40d3-aa8a-6af686fb67ad2024-01-08WarningsExact identifier
application number: M017
OPRAVAMETHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC05552560-e283-5eba-e063-6294a90a65f72024-01-06WarningsExact identifier
application number: M017
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact 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