Menthol Pain Relieving Gel

Product NDC
13709-357
Requested package NDC
13709-357-01
11-digit product format
137090357
Labeler code
13709
Product ID
13709-357_513a206c-bbf7-3e51-e063-6294a90adf7a
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Relieving Gel
Dosage form
GEL
Route
TOPICAL
Labeler
NeilMed Pharmaceuticals Inc
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-07
Substance
MENTHOL
Active strength
4.54 g/227g
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
Menthol Pain Relieving Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.54 g/227g

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
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
513a206c-bbf6-3e51-e063-6294a90adf7aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-357-01Menthol Pain Relieving Gel1 in 1 CARTONGEL11
13709-357-01Menthol Pain Relieving Gel227 g in 1 TUBEGEL2271

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 4 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Earwax Removal DropsCARBAMIDE PEROXIDEMeijer Distribution Inc900108c6-0324-644a-e053-2a95a90a3b2b2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal KitCARBAMIDE PEROXIDEWarner Tech-care Products, LLC5851c1f6-c15b-447c-b495-3707e7a12bdb2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal DropsCARBAMIDE PEROXIDEWarner Tech-care Products, LLC1c97783b-dcdf-4f95-8516-0d7f197cbc272025-02-28WarningsExact identifier
application number: M014
TopCare Earwax Removal KitCARBAMIDE PEROXIDETOPCO ASSOCIATES LLC890cc9b6-41a5-480a-bc94-45c8d4fdeef32025-02-28WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal Aid DropsCARBAMIDE PEROXIDEOaktree Products Inc2922dde2-d082-437b-8f51-4a91ced20a582025-02-28WarningsExact identifier
application number: M014
Best Choice Earwax Removal DropsCARBAMIDE PEROXIDEValu Merchandisers Company3ae6255f-f494-412b-af76-3579de08ed232025-02-28WarningsExact identifier
application number: M014
Equaline Earwax Removal DropsCARBAMIDE PEROXIDEUnited Natural Foodsd853567a-ce8d-40a8-be1e-27176802ff642025-02-28WarningsExact identifier
application number: M014
Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDEFamily Dollar Services Inc26ebf208-4710-4af2-aa2d-b2040b85cf852025-02-28WarningsExact identifier
application number: M014
FOSTER AND THRIVE EARWAX REMOVAL DROPSCARBAMIDE PEROXIDEA-S Medication Solutions0a571ae8-237b-447d-b697-02b30692b6b12025-02-24WarningsExact identifier
application number: M014
Pain Be GoneMENTHOLBack to Earth Inc.f49e718b-ef89-b648-e053-2a95a90a96c82025-01-29WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEMedtech Products Inc.43649ba3-75e0-4dcf-9172-23767dbaeda62025-01-27WarningsExact identifier
application number: M014
HylaTearsEYE DROPSHyalogic LLC2b5fc4c4-843c-8d3d-e063-6394a90a5a1b2025-01-10WarningsExact identifier
application number: M014
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
application number: M014
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal Kit Ear wax dropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Servicesc9bd4c1f-b3b8-4bdc-b529-3a98b657e6282024-12-31WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal DropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Services6180835c-d7a7-4bf7-95cb-0fd3c81402532024-12-31WarningsExact identifier
application number: M014
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
application number: M014
ERO Ear Wax Removal KitCARBAMIDE PEROXIDE 6.5%Randob Labsfbf8a6f2-531d-5047-e053-6294a90aaa012024-12-15WarningsExact identifier
application number: M014
Harris Teeter Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Harris Teeter LLCdda4c4bf-425e-4fff-e053-2a95a90a51bc2024-12-15WarningsExact identifier
application number: M014
Isopropyl AlcoholISOPROPYL ALCOHOLMazza Healthcare, LLCee83ba9f-ac65-48b7-9f84-5be6fec9a9092024-11-21WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN513a206c-bbf6-3e51-e063-6294a90adf7a1
311502menthol 0.02 MG/MG Topical GelSCD513a206c-bbf6-3e51-e063-6294a90adf7a1
311502menthol 2 % Topical GelSY513a206c-bbf6-3e51-e063-6294a90adf7a1
311502menthol 2 % topical stickSY513a206c-bbf6-3e51-e063-6294a90adf7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-357-01137090357011 TUBE in 1 CARTON (13709-357-01) / 227 g in 1 TUBE1 tube2026-05-07NoNoCurrent