FDA.reportPublic FDA data

Lidocaine Pain Relief Roll on

Product NDC
13709-360
11-digit product format
137090360
Labeler code
13709
Product ID
13709-360_58ff9d2d-99e7-8f98-e063-6394a90a8de7
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Relief Roll on
Dosage form
LIQUID
Route
TOPICAL
Labeler
NeilMed Pharmaceuticals Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-17
Substance
LIDOCAINE
Active strength
3.4 g/85g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
Lidocaine Pain Relief Roll on
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE3.4 g/85g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2197844Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58ff9d2d-99e6-8f98-e063-6394a90a8de7Available on FDA.report

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 132 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
application number: M017
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJHK Inc5a4ac4cc-015a-48e7-81f8-93a895049afd2024-04-25WarningsExact identifier
application number: M017
Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.ede15818-5d17-477d-a8be-7b36bb0770a62024-04-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONENeilmed Pharmaceuticals Inc.14b4f066-fde4-ac97-e063-6394a90ae64c2024-04-20WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief PatchMENTHOL 5%Walgreens Companye33c90d1-2729-970f-e053-2995a90ad97a2024-04-18WarningsExact identifier
application number: M017
HealthWise Cold Therapy Pain Relief PatchMENTHOLVeridian Healthcare0ce356e0-90a3-ad52-e063-6294a90a404a2024-04-18WarningsExact identifier
application number: M017
Walgreens Scalp Relief External analgesicHYDROCORTISONEWalgreen Companyda0a24c7-9295-4f22-b2c7-40000dad4b812024-04-18WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief PatchCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare164d4d62-00c0-e06d-e063-6294a90abd732024-04-17WarningsExact identifier
application number: M017
TIGER Balm PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.ca601b02-e9be-4d8d-a384-c62553302ceb2024-04-16WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592a40a-a647-34bd-e063-6394a90a0a102024-04-08WarningsExact identifier
application number: M017
MenticamCAMPHOR, MENTHOL, METHYL SALICYLATEPureTek Corporation081837a8-9669-be1f-e063-6394a90a9d202024-04-05WarningsExact identifier
application number: M017
Pain Relieving LinimentCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.97a0c839-0927-4e54-aee2-ded2016ac4a02024-04-02WarningsExact identifier
application number: M017
HealthWise Capsaicin Heat PatchCAPSAICINVeridian Healthcare150c1f09-8aa7-67ea-e063-6294a90a950a2024-04-01WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender ScentLIDOCAINE HCIVeridian Healthcare150d3e54-5c8d-19ef-e063-6394a90a70c22024-04-01WarningsExact identifier
application number: M017
Meijer Pain Relief CreamLIDOCAINEMeijer Distribution07ecee44-387a-cdce-e063-6294a90ab9c92024-03-27WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA141aa2a7-8789-1127-e063-6294a90a2d232024-03-20WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13709-360-01137090360011 BOTTLE, WITH APPLICATOR in 1 CARTON (13709-360-01) / 85 g in 1 BOTTLE, WITH APPLICATOR2026-08-17NoNoCurrent