Medrox-Rx

Product NDC
45861-005
11-digit product format
458610005
Labeler code
45861
Product ID
45861-005_0464d781-fa9d-442a-a7a7-94a3c8cf4786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methyl salicylate, menthol, capsaicin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmaceutica North America, Inc.
Application
part348
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-27
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
24 g/120g; g/120g; g/120g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45861-005DDiscontinued by firm2026-10-12
excluded packagepackage45861-00545861-005-01DDiscontinued by firm2026-10-12

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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45861-005-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45861-005-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45861-005-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45861-005-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45861-005-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45861-005-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45861-005-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45861-005-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45861-005-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45861-005-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45861-005-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45861-005-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45861-005-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45861-005-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45861-005-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45861-005-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage45861-005-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage45861-005-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage45861-005-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45861-005-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45861-005-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage45861-005-01IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45861-005-012025-03-04C16284748780-197449f38-d3f1-f6ea-e053-dbdaa90aa703Medrox-Rx
45861-005-012019-11-13C16284748780-197449f38-d3f1-f6ea-e053-dbdaa90aa703Medrox-Rx

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45861-005-01GM - Gram45861-00580e5a063-7b92-401d-95fd-1233ef5e48f312013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
capsaicinACTIVE INGREDIENTS07O44R1ZMMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
mentholACTIVE INGREDIENTL7T10EIP3AMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
methyl salicylateACTIVE INGREDIENTLAV5U5022YMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
capsaicinACTIVE MOIETYS07O44R1ZMMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
mentholACTIVE MOIETYL7T10EIP3AMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
methyl salicylateACTIVE MOIETYLAV5U5022YMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RMEDROX-RX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) OINTMENT [PHARMACEUTICA NORTH AMERICA, INC.]8