FDA.reportPublic FDA data

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 2 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
application number: M014
DoloEarCARBAMIDE PEROXIDEPharmadel LLC352df636-0469-c33e-e063-6294a90a22242026-03-26WarningsExact identifier
application number: M014
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
application number: M014
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
application number: M014
Ear Wash Refill CVSCARBAMIDE PEROXIDECVS311c5951-949c-b38b-e063-6294a90aa4a92026-02-27WarningsExact identifier
application number: M014
ProRinse Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Incca82db28-1ef7-41c6-a46b-7bfc7b09281c2026-02-09WarningsExact identifier
application number: M014
Wax Away Earwax Removal AidCARBAMIDE PEROXIDEMcKeon Products Inc8e6c8bf3-d3ec-4605-b8e5-47612f94db892026-02-09WarningsExact identifier
application number: M014
Wax Away Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Inc22c6f7db-814b-4e70-9fbe-bbb86385d0702026-02-09WarningsExact identifier
application number: M014
blue goo FREEZING PAIN RELIEF Topical AnalgesicMENTHOL 4%Garcoa, Inc.e90e35e8-47a7-4f9b-ba8a-1cfd15b439952026-02-06WarningsExact identifier
application number: M014
CaseysDishwashingSoapDISHWASHING DETERGENT JUNIPER FORESTKYNC DESIGN LLCb563af92-606c-7c12-e053-2a95a90abbb72026-01-23WarningsExact identifier
application number: M014
CaseysLavenderCASEYS HAND SOAP LAVENDER SCENTKYNC Design LLCb5bc8770-13ef-36dc-e053-2995a90a3f512026-01-23WarningsExact identifier
application number: M014
Les Coja Organic SPF 30ETHYLHEXYL SALICYLATE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANERNA PHARMA, LLC485d31e4-a2a9-8165-e063-6294a90a14fc2026-01-14WarningsExact identifier
application number: M014
Dri-EarDRI-EARS.S.S. Company12f07636-bb60-5fd4-e063-6294a90a39a82026-01-08WarningsExact identifier
application number: M014
Clinere Ear Wax RemoverCARBAMIDE PEROXIDEQuest Productsd967eac3-0aac-a7ae-e053-2995a90a0e1e2026-01-08WarningsExact identifier
application number: M014
Deluxe Ear Wash systemCARBAMIDE PEROXIDEWalgreens14923bf4-5b4f-a26a-e063-6294a90aa6b52025-12-10WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%GeriCare Pharmaceutical Corp239702af-cf93-43ee-b1af-8e53642395c12025-12-09WarningsExact identifier
application number: M014
EELHOE Whole Body Deodorant Solid BalmGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.45696491-3c41-39c6-e063-6394a90abae32025-12-07WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Peppermint Oil and Aloe ConditionerSALICYLIC ACIDRNA PHARMA, LLC450dff05-9410-5366-e063-6294a90ae0d42025-12-03WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Oil TreatmentSALICYLIC ACIDRNA PHARMA, LLC450ec8ae-2405-8d2f-e063-6394a90a50db2025-12-03WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Peppermint Oil and AloeSALICYLIC ACIDRNA PHARMA, LLC44fa5eed-93e2-cb3a-e063-6294a90a3b042025-12-02WarningsExact 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