Indications and uses
Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.
DRUG FACTS:
Methyl Salicylate 20.00%
Menthol 5.00%
Capsaicin 0.0375%
Analgesic/Counterirritant
Analgesic/Counterirritant
External Analgesic
Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Consult physician for children under 12.
Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.
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
NDC 68258-3984-04
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2001749 | capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical Ointment | PSN | 2 |
| 2001750 | Medrox 0.038 % / 5 % / 20 % Topical Ointment | PSN | 2 |
| 2001750 | capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical Ointment [Medrox] | SBD | 2 |
| 2001749 | capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Topical Ointment | SCD | 2 |
| 2001749 | capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical Ointment | SY | 2 |
| 2001750 | Medrox (capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG) Topical Ointment | SY | 2 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | PDF417 | SAMPLE*68258398404 | NDC 68258-3984-04------PHARMACEUTICA.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-3984-4 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d8fb-cd31-e053-dbdaa90ab51a | Medrox (Medroxin) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-3984-4 | Medrox | 120 g in 1 BOTTLE | OINTMENT | 120 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-3984 | MEDROX (METHYL SALICYLATE, MENTHOL, CAPSAICIN ) OINTMENT [DISPENSING SOLUTIONS, INC.] | 2 | Legacy NDC, 1 package rows | 20130927_771596d4-58c3-4144-99e5-7c8b3b27d1bf.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68258-3984-4 | GM - Gram | 68258-3984 | 8b9d672d-2f0c-4147-8884-6e40e653c117 | 1 | 2013-10-17 |
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAPSAICIN | ACTIVE INGREDIENT | S07O44R1ZM | 2 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | 2 | |
| CAPSAICIN | ACTIVE MOIETY | S07O44R1ZM | 2 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 2 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PEG-150 DISTEARATE | INACTIVE INGREDIENT | 6F36Q0I0AC | 2 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68258-3984 | 68258-3984-4 |
| 45861-001 |
Every source-derived ingredient row is available through these pages.
| 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 |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPONGE / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING / ORAL | 16 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EFFERVESCENT / ORAL | 1.5 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPONGE / TOPICAL | 11 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, FILM COATED / ORAL | 1.68 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / SUBCUTANEOUS | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TOPICAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAMUSCULAR | 1.62 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TRANSDERMAL | 85 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 77c9d2e7-6ce0-43dd-9537-a01d087e4d2d | 771596d4-58c3-4144-99e5-7c8b3b27d1bf | 2013-09-27 | Warnings | 77c9d2e7-6ce0-43dd-9537-a01d087e4d2d 771596d4-58c3-4144-99e5-7c8b3b27d1bf |
Adverse event summaries are temporarily unavailable. Other product information remains available.