Medrox

Manufacturer: H.J. Harkins Company, Inc.
Effective date: 2012-01-19
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:30:37

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

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

Medrox

(medroxcin)

Effective
Soothing
Long Lasting

Pain Relief Ointment

For Questions or Comments
Please Email:
info@ipnarx.com

120gm (4 fl oz)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2001749	capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical Ointment	PSN	3
2001750	Medrox 0.038 % / 5 % / 20 % Topical Ointment	PSN	3
2001750	capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical Ointment [Medrox]	SBD	3
2001749	capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical Ointment	SCD	3
2001749	capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical Ointment	SY	3
2001750	Medrox (capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG) Topical Ointment	SY	3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-095-02	2019-11-13	C162847	48780-1	97449f38-c194-f6ea-e053-dbdaa90aa703	Medrox (Medroxin)
52959-095-60	2019-11-13	C162847	48780-1	97449f38-c194-f6ea-e053-dbdaa90aa703	Medrox (Medroxin)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-095-02	Medrox	120 g in 1 BOTTLE	OINTMENT	120		3
52959-095-60	Medrox	60 g in 1 BOTTLE	OINTMENT	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-095	MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 2 package rows	20120120_7031eb87-4378-463b-9b00-aa8fdc3dc770.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-095-02	GM - Gram	52959-095	91836058-33bc-473c-8401-5e7f4a0937ec	1	2012-07-24
52959-095-60	GM - Gram	52959-095	f17c79b0-11c7-4bef-b783-9271c5f86d18	1	2012-07-24
45861-001-01	GM - Gram	45861-001	6ddd1867-6c39-488c-8e4f-1057c5756f31	1	2012-07-24
45861-001-60	GM - Gram	45861-001	87e58244-310f-4c45-8f42-efff51f30e93	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	3
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	3
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	3
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

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

Medrox
METHYL SALICYLATE, MENTHOL, CAPSAICIN
METHYL SALICYLATE
SALICYLIC ACID
MENTHOL
CAPSAICIN
WATER
CETYL ALCOHOL
PEG-150 DISTEARATE
ISOPROPYL MYRISTATE
GLYCERIN
SODIUM LAURYL SULFATE
POLYSORBATE 20
TROLAMINE
PROPYLENE GLYCOL
METHYLPARABEN
PROPYLPARABEN
DIAZOLIDINYL UREA
FD&C BLUE NO. 1
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52959-095	52959-095-02, 52959-095-60
45861-001

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
METHYL SALICYLATE	LAV5U5022Y	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
CAPSAICIN	S07O44R1ZM	ACTIB
WATER	059QF0KO0R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
PEG-150 DISTEARATE	6F36Q0I0AC	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
TROLAMINE	9O3K93S3TK	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0806c64e-e77d-4aa8-ad24-67714b5c5148			7031eb87-4378-463b-9b00-aa8fdc3dc770	2012-01-19	Warnings	Exact identifier spl id: 0806c64e-e77d-4aa8-ad24-67714b5c5148 spl set id: 7031eb87-4378-463b-9b00-aa8fdc3dc770

Reported adverse events (FAERS/openFDA)#

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