ORTHOGEL Menthol 3.5%

Product NDC
71726-007
11-digit product format
717260007
Labeler code
71726
Product ID
71726-007_cea6fae7-e526-454c-81a2-72dea124b5c2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
LiquidCapsule Manufacturing LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-06
Substance
MENTHOL
Active strength
3.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
ORTHOGEL Menthol 3.5%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3.5 g/100g

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
808955Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fd4b7ac-1971-4abe-8fbb-74ab69e12061Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71726-007-02ORTHOGEL Menthol 3.5%113.4 g in 1 TUBEGEL113.42
71726-007-03ORTHOGEL Menthol 3.5%113.4 g in 1 JARGEL113.42
71726-007-04ORTHOGEL Menthol 3.5%453.6 g in 1 BOTTLEGEL453.62
71726-007-05ORTHOGEL Menthol 3.5%907.2 g in 1 BOTTLEGEL907.22
71726-007-06ORTHOGEL Menthol 3.5%3580 g in 1 JUGGEL35802

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 147 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLUE SPRING Foot and Leg ComfortMENTHOLACA MANAGEMENT LLC5f52218d-eea4-4640-b820-84c077ab98ba2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Red Hot Pepper Pain Relief CreamMENTHOL, CAPSAICINACA MANAGEMENT LLC36293885-b2dd-4fba-9748-35a3c9e050782023-11-06WarningsExact identifier
application number: M017
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
application number: M017
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsExact identifier
application number: M017
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsExact identifier
application number: M017
ARTHRO LIFE Instant Pain Relief CreamMENTHOLBIOBEST SERVICES LLC66eb1a78-6861-4693-b68e-bd4a664fc0752023-11-06WarningsExact identifier
application number: M017
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
application number: M017
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
application number: M017
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
application number: M017
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
application number: M017
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
application number: M017
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLC89c80a8f-227d-4ec0-9327-683892e73b6a2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808955menthol 3.5 % Topical GelPSN4fd4b7ac-1971-4abe-8fbb-74ab69e120612
808955menthol 0.035 MG/MG Topical GelSCD4fd4b7ac-1971-4abe-8fbb-74ab69e120612
808955menthol 3.5 % Topical GelSY4fd4b7ac-1971-4abe-8fbb-74ab69e120612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71726-007-0271726000702113.4 g in 1 TUBE (71726-007-02) 113.4 g2025-06-06NoNoCurrent
71726-007-0371726000703113.4 g in 1 JAR (71726-007-03) 113.4 g2025-06-06NoNoCurrent
71726-007-0471726000704453.6 g in 1 BOTTLE (71726-007-04) 453.6 g2025-06-06NoNoCurrent
71726-007-0571726000705907.2 g in 1 BOTTLE (71726-007-05) 907.2 g2025-06-06NoNoCurrent
71726-007-06717260007063580 g in 1 JUG (71726-007-06) 3580 g2025-06-06NoNoCurrent