MUSCLE

Product NDC
59898-805
11-digit product format
598980805
Labeler code
59898
Product ID
59898-805_32475ac6-c4d4-938d-e063-6294a90a572d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
WATER-JEL TECHNOLOGIES
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-04-19
Substance
MENTHOL
Active strength
3.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59898-80559898-805-10DDiscontinued by firm2026-10-20
excluded packagepackage59898-80559898-805-22DDiscontinued by firm2026-10-20
excluded packagepackage59898-80559898-805-24DDiscontinued by firm2026-10-20
excluded packagepackage59898-80559898-805-25DDiscontinued by firm2026-10-20

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 2 · 62 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559898-805-22d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559898-805-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559898-805-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559898-805-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659898-805-22f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659898-805-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659898-805-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659898-805-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159898-805-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159898-805-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159898-805-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159898-805-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159898-805-222ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159898-805-232ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859898-805-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859898-805-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859898-805-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859898-805-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859898-805-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859898-805-23a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159898-805-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159898-805-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159898-805-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159898-805-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159898-805-22cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159898-805-23cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059898-805-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059898-805-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059898-805-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059898-805-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059898-805-22cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059898-805-23cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159898-805-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159898-805-24302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159898-805-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159898-805-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159898-805-22302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159898-805-23302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059898-805-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059898-805-24ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059898-805-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059898-805-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059898-805-22ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059898-805-23ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059898-805-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059898-805-240efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059898-805-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059898-805-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059898-805-220efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059898-805-230efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0859898-805-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859898-805-24ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859898-805-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859898-805-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859898-805-22ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859898-805-23ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0359898-805-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359898-805-24367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359898-805-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359898-805-25367a005e9d99…383a685ebd0f…

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
MUSCLE
Listing expiration
2026-12-31

Active Ingredients#

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

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
1af399af-07b0-4899-9bcc-1e244b63b1cfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-805-05MUSCLE3.8 mL in 1 PACKETGEL3.87
59898-805-05MUSCLE96 in 1 BOX, UNIT-DOSEGEL967
59898-805-10MUSCLE59 mL in 1 BOTTLE, SPRAYGEL597
59898-805-17MUSCLE3.8 mL in 1 PACKETGEL3.87
59898-805-17MUSCLE1728 in 1 CARTONGEL17287
59898-805-18MUSCLE5 in 1 BOX, UNIT-DOSEGEL57
59898-805-18MUSCLE3.8 mL in 1 PACKETGEL3.87
59898-805-20MUSCLE3.8 mL in 1 PACKETGEL3.87
59898-805-20MUSCLE24 in 1 CARTONGEL247
59898-805-21MUSCLE473 mL in 1 BOTTLE, PUMPGEL4737
59898-805-22MUSCLE80 mL in 1 BOTTLE, DISPENSINGGEL807
59898-805-23MUSCLE946 mL in 1 BOTTLE, PUMPGEL9467
59898-805-24MUSCLE3784 mL in 1 BOTTLE, PUMPGEL37847
59898-805-25MUSCLE118 mL in 1 TUBEGEL1187

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
MENTHOLACTIVE MOIETYL7T10EIP3AMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
ANGELICA ARCHANGELICA ROOTINACTIVE INGREDIENTDTN01M69SNMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
ASIAN GINSENGINACTIVE INGREDIENTCUQ3A77YXIMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941MUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-805MUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]7Current NDC, Legacy NDC, 14 package rows20250410_1af399af-07b0-4899-9bcc-1e244b63b1cf.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 63 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4x Medicated Toothache and Gum CreamBENZOCAINEKrogera8c5090a-24f9-4e73-e053-2a95a90acca02025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINECVS0a5a8cd0-d680-8a0f-e063-6294a90aa65c2025-11-14WarningsExact identifier
application number: M017
PM Toothache ReliefBENZOCAINEWalgreense816f742-fba9-3c12-e053-2a95a90a192f2025-11-14WarningsExact identifier
application number: M017
4x Medicated Toothache and Gum CreamBENZOCAINEWalgreensa71c2092-4ece-b82e-e053-2995a90ac9332025-11-14WarningsExact identifier
application number: M017
After Bite OutdoorDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands22b891a9-6386-dee1-e063-6394a90a5c2f2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
application number: M017
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger3f881349-fcdd-e276-e063-6394a90ae49e2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434cb8b2-a996-5360-e063-6394a90ada032025-11-13WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED4360e3ec-7a4b-b28e-e063-6294a90a0bd62025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED4360e3be-0ec4-cd57-e063-6394a90aca632025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED43616ad7-58bb-e5ad-e063-6394a90a192b2025-11-13WarningsExact identifier
application number: M017
4x Medicated Severe Toothache and Gum GelBENZALKONIUM CHLORIDEMeijer97ce7890-5093-1763-e053-2a95a90afae72025-11-13WarningsExact identifier
application number: M017
Pain RelieverCAMPHOR, MENTHOLKool 'N Fit Inc.2253f6bd-5707-b993-e063-6394a90aa74a2025-11-13WarningsExact identifier
application number: M017
Rapid ReliefPLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED4360e0d1-46cd-ab4b-e063-6394a90a55e12025-11-12WarningsExact identifier
application number: M017
CVS Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECVS8723e097-296f-784a-e053-2991aa0a552e2025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154d8821-3e76-b0e2-e063-6294a90ae0772025-11-12WarningsExact identifier
application number: M017
Good neighbor Pharmacy Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEAMERISOURCEBERGEN DRUG CORPORATION87395273-380c-7cef-e053-2991aa0a54c62025-11-12WarningsExact identifier
application number: M017
Quality Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEChain Drug Marketing Association8735b298-83f3-0b5d-e053-2a91aa0a82922025-11-12WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.1550e794-b3c0-4769-e063-6294a90a8c2d2025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808955menthol 3.5 % Topical GelPSN1af399af-07b0-4899-9bcc-1e244b63b1cf7
808955menthol 0.035 MG/MG Topical GelSCD1af399af-07b0-4899-9bcc-1e244b63b1cf7
808955menthol 3.5 % Topical GelSY1af399af-07b0-4899-9bcc-1e244b63b1cf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-805-055989808050596 PACKET in 1 BOX, UNIT-DOSE (59898-805-05) / 3.8 mL in 1 PACKET96 packet2010-04-190000-00-00NoNoCurrent
59898-805-105989808051059 mL in 1 BOTTLE, SPRAY (59898-805-10) 59 ml2013-03-170000-00-00NoNoCurrent
59898-805-17598980805171728 PACKET in 1 CARTON (59898-805-17) / 3.8 mL in 1 PACKET1728 packet2010-04-190000-00-00NoNoCurrent
59898-805-18598980805185 PACKET in 1 BOX, UNIT-DOSE (59898-805-18) / 3.8 mL in 1 PACKET5 packet2010-04-190000-00-00NoNoCurrent
59898-805-205989808052024 PACKET in 1 CARTON (59898-805-20) / 3.8 mL in 1 PACKET24 packet2010-04-190000-00-00NoNoCurrent
59898-805-2159898080521473 mL in 1 BOTTLE, PUMP (59898-805-21) 473 ml2010-04-190000-00-00NoNoCurrent
59898-805-225989808052280 mL in 1 BOTTLE, DISPENSING (59898-805-22) 80 ml2010-04-190000-00-00NoNoCurrent
59898-805-2359898080523946 mL in 1 BOTTLE, PUMP (59898-805-23) 946 ml2010-04-190000-00-00NoNoCurrent
59898-805-24598980805243784 mL in 1 BOTTLE, PUMP (59898-805-24) 3784 ml2010-04-190000-00-00NoNoCurrent
59898-805-2559898080525118 mL in 1 TUBE (59898-805-25) 118 ml2010-04-190000-00-00NoNoCurrent