LCDO. ORLANDO RIVERA ARTHRITIS Topical Analgesic

Product NDC
65121-495
11-digit product format
651210495
Labeler code
65121
Product ID
65121-495_490f5cfb-7192-6f35-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Pure Source, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-21
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
15 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65121-495DDiscontinued by firm2026-10-05
excluded packagepackage65121-49565121-495-02DDiscontinued by firm2026-10-05

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 1 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65121-495-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65121-495-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65121-495-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65121-495-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65121-495-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65121-495-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65121-495-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65121-495-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65121-495-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65121-495-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65121-495-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65121-495-02557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ALCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ALCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLCDO. ORLANDO RIVERA ARTHRITIS TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PURE SOURCE INC.]1