Medrox

Manufacturer
Dispensing Solutions, Inc. | PSS World Medical, Inc.
Effective date
2013-09-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:37:01

Label at a glance#

ProductMedrox
Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN
Label structure9 sections

Indications and uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Dosage and administration

Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate      20.00%

Menthol                     5.00%

Capsaicin                  0.0375%

PURPOSE

OTC - PURPOSE SECTION

Analgesic/Counterirritant

Analgesic/Counterirritant

External Analgesic

USES

INDICATIONS & USAGE SECTION

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

WARNINGS

WARNINGS SECTION

  • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Deionized Water, Cetyl Alcohol, PEG-150 Distearate, Isopropyl Myristate, Glycerin, Sodium Lauryl Sulfate, Polysorbate-20, Triethanolamine, Acrylates Copolymer, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, FD and C Blue 1, D and C Yellow 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 68258-3984-04

NDC 68258-3984-04NDC 68258-3984-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2001749capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical OintmentPSN2
2001750Medrox 0.038 % / 5 % / 20 % Topical OintmentPSN2
2001750capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical Ointment [Medrox]SBD2
2001749capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical OintmentSCD2
2001749capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical OintmentSY2
2001750Medrox (capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG) Topical OintmentSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codePDF417SAMPLE*68258398404NDC 68258-3984-04------PHARMACEUTICA.jpg

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
68258-3984-42019-11-27C16284748780-19855d018-d8fb-cd31-e053-dbdaa90ab51aMedrox (Medroxin)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3984-4Medrox120 g in 1 BOTTLEOINTMENT1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3984MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20130927_771596d4-58c3-4144-99e5-7c8b3b27d1bf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-3984-4GM - Gram68258-39848b9d672d-2f0c-4147-8884-6e40e653c11712013-10-17
45861-001-01GM - Gram45861-0016ddd1867-6c39-488c-8e4f-1057c5756f3112012-07-24
45861-001-60GM - Gram45861-00187e58244-310f-4c45-8f42-efff51f30e9312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
CAPSAICINACTIVE MOIETYS07O44R1ZM2
MENTHOLACTIVE MOIETYL7T10EIP3A2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW42
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0AC2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68258-398468258-3984-4
45861-001

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 495 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / NASAL14 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING / ORAL16 mgExact identifier — unii candidate
42 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii candidate
42 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, FILM COATED / ORAL1.68 mgExact identifier — unii candidate
22 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL / TOPICAL9.3 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FOR SUSPENSION / ORAL264 mgExact identifier — unii candidate
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / TOPICAL213 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / SUBCUTANEOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / VAGINAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAMUSCULAR1.62 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JINSERT / VAGINAL15 mgExact identifier — unii candidate
42 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
77c9d2e7-6ce0-43dd-9537-a01d087e4d2d771596d4-58c3-4144-99e5-7c8b3b27d1bf2013-09-27WarningsExact identifier
spl id: 77c9d2e7-6ce0-43dd-9537-a01d087e4d2d
spl set id: 771596d4-58c3-4144-99e5-7c8b3b27d1bf

Reported adverse events (FAERS/openFDA)#

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