Thera Plus Pain Relief Arthritis and Muscle

Product NDC
80684-138
11-digit product format
806840138
Labeler code
80684
Product ID
80684-138_2f34ac92-f455-28b1-e063-6294a90a6cfc
Type
HUMAN OTC DRUG
Nonproprietary name
CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-28
Substance
CAPSAICIN
Active strength
.25 mg/g
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
Thera Plus Pain Relief Arthritis and Muscle
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dcff0a2d-7190-4b0c-abde-ba009b8ef005Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-138-00Thera Plus Pain Relief Arthritis and Muscle42.5 g in 1 TUBECREAM42.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-138THERA PLUS PAIN RELIEF ARTHRITIS AND MUSCLE (CAPSAICIN) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20250302_dcff0a2d-7190-4b0c-abde-ba009b8ef005.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 98 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d04799f-946d-ac53-e063-6294a90afeb72025-03-11WarningsExact identifier
application number: M017
Muscle and Joint CareLIDOCAINEVege Labs LLC.301966b5-b535-dc04-e063-6394a90aec172025-03-11WarningsExact identifier
application number: M017
Arctic Blast Pain ReleivingMENTHOL, CAMPHOR (SYNTHETIC)Nutriomo Labs Pte, Ltdd5e7d26d-4f63-4b7b-a173-fe3a794c84592025-03-10WarningsExact identifier
application number: M017
Anti ItchWALGREENWalgreens30014ff0-2519-4031-e063-6394a90ae07b2025-03-10WarningsExact identifier
application number: M017
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact identifier
application number: M017
Thunder Fck Male Genital DesensitizerBENZOCAINEPRODUCT MAX GROUP INC93188a42-0d3c-4159-bdc7-bbc5ec5c67442025-03-06WarningsExact identifier
application number: M017
Body Action Climax Guard DelayBENZOCAINEPRODUCT MAX GROUP INCf88e0b42-974e-4f46-a93b-34b06320770a2025-03-06WarningsExact identifier
application number: M017
XENCARE INFLAMAX NATURAL TOPICAL PAINMENTHOL, CAPSAICINXenex Laboratories Inc.25b9621b-3c16-3cb9-e063-6294a90ab5982025-03-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY1cd37b69-2cfb-130d-e063-6394a90af50b2025-03-06WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Co.c22bba5c-bb6f-494e-987a-f6e36c1b48932025-03-06WarningsExact identifier
application number: M017
Redicare Burn GelREDICARE BURN GELRedicare LLC947ac362-acfb-3508-e053-2a95a90a28732025-03-05WarningsExact identifier
application number: M017
Thera Plus Hydrocortisone Maximum StrengthHYDROCORTISONEFOURSTAR GROUP USA, INC.c2bc8f0c-38ea-4124-bc51-bf22e6751a922025-03-04WarningsExact identifier
application number: M017
Thera Plus Eczema Hydrocortisone Anti ItchHYDROCORTISONEFourstar Group USA, Inc.7c72217b-db9a-4573-9f14-4c11528fa4522025-03-04WarningsExact identifier
application number: M017
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.fb89dca6-c0c0-4092-b3f5-e59c956c3d6c2025-03-04WarningsExact identifier
application number: M017
Peppermint soothing creamCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOLHenan Lijitang Medical Technology Co., Ltd.2f6bc332-3006-710d-e063-6394a90acea52025-03-03WarningsExact identifier
application number: M017
Thera Plus Pain Relief Arthritis and MuscleCAPSAICINFOURSTAR GROUP USA, INC.dcff0a2d-7190-4b0c-abde-ba009b8ef0052025-02-28WarningsExact identifier
application number: M017
ndc (product): 80684-138
GoodSense Anti-ItchDIPHENHYDRAMINE HCL, ZINC ACETATEGeiss, Destin & Dunn, Inc2f38bdfc-6135-1b8a-e063-6294a90a67032025-02-28WarningsExact identifier
application number: M017
Capsaicin 0.05% CreamCAPSAICIN 0.05%Puretek Corporation2cf17a28-711f-77bd-e063-6394a90a70612025-02-28WarningsExact identifier
application number: M017
Lidocaine Pain-Relief PatchesLIDOCAINE PATCHMeijer, Inc2f247929-6bff-1e59-e063-6394a90acdba2025-02-27WarningsExact identifier
application number: M017
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSNdcff0a2d-7190-4b0c-abde-ba009b8ef0052
198555capsaicin 0.25 MG/ML Topical CreamSCDdcff0a2d-7190-4b0c-abde-ba009b8ef0052
198555capsaicin 0.025 % Topical CreamSYdcff0a2d-7190-4b0c-abde-ba009b8ef0052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-138-008068401380042.5 g in 1 TUBE (80684-138-00) 42.5 g2025-02-28NoNoCurrent