Medrox

Product NDC
52959-095
11-digit product format
529590095
Labeler code
52959
Product ID
52959-095_0806c64e-e77d-4aa8-ad24-67714b5c5148
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-02-09
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
20 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-095IInactivated by FDA2026-10-12
excluded packagepackage52959-09552959-095-02IInactivated by FDA2026-10-12
excluded packagepackage52959-09552959-095-60IInactivated by FDA2026-10-12

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 · 66 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 packagepackage52959-095-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-095-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-095-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-095-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-095-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-095-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-095-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-095-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-095-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-095-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-095-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-095-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-095-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-095-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-095-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-095-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-095-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-095-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-095-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-095-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-095-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-095-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-095-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-095-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-095-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-095-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-095-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-095-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-095-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-095-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-095-02fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-095-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-095-0286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-095-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-095-02bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-095-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-095-028dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-095-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-095-02e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-095-60e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-095-022019-11-13C16284748780-197449f38-c194-f6ea-e053-dbdaa90aa703Medrox (Medroxin)
52959-095-602019-11-13C16284748780-197449f38-c194-f6ea-e053-dbdaa90aa703Medrox (Medroxin)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-095-02Medrox120 g in 1 BOTTLEOINTMENT1203
52959-095-60Medrox60 g in 1 BOTTLEOINTMENT603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-095-02GM - Gram52959-09591836058-33bc-473c-8401-5e7f4a0937ec12012-07-24
52959-095-60GM - Gram52959-095f17c79b0-11c7-4bef-b783-9271c5f86d1812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
MENTHOLACTIVE INGREDIENTL7T10EIP3AMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
CAPSAICINACTIVE MOIETYS07O44R1ZMMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
MENTHOLACTIVE MOIETYL7T10EIP3AMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RMEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-095MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 2 package rows20120120_7031eb87-4378-463b-9b00-aa8fdc3dc770.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001749capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical OintmentPSN7031eb87-4378-463b-9b00-aa8fdc3dc7703
2001750Medrox 0.038 % / 5 % / 20 % Topical OintmentPSN7031eb87-4378-463b-9b00-aa8fdc3dc7703
2001750capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical Ointment [Medrox]SBD7031eb87-4378-463b-9b00-aa8fdc3dc7703
2001749capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical OintmentSCD7031eb87-4378-463b-9b00-aa8fdc3dc7703
2001749capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical OintmentSY7031eb87-4378-463b-9b00-aa8fdc3dc7703
2001750Medrox (capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG) Topical OintmentSY7031eb87-4378-463b-9b00-aa8fdc3dc7703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-095-0252959009502120 g in 1 BOTTLE120 gHistorical
52959-095-605295900956060 g in 1 BOTTLE60 gHistorical