FDA.reportPublic FDA data

MOBISYL

Manufacturer
BF ASCHER AND CO INC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:44

Label at a glance#

ProductMOBISYL
Active ingredientTROLAMINE SALICYLATE
Label structure13 sections

Storage and handling

Other information store tightly capped at 59°- 86° F (15°- 30° C) mfd. in the USA for B.F. Ascher & Co., Inc.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient ...............................Purpose
Trolamine salicylate 10%.....................Topical analgesic

INDICATIONS & USAGE SECTION

Use

For temporarily relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains

OTC - PURPOSE SECTION

Use

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains.

WARNINGS SECTION

Warnings
For external use only.
Use only as directed

OTC - DO NOT USE SECTION

Do not use

  • on or near the eyes
  • on broken, damaged, or irritated skin

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and older: massage a liberal amount into the affected area three or four times a day, especially before retiring
  • children under 12 years of age: consult your doctor

STORAGE AND HANDLING SECTION

Other information

  • store tightly capped at 59°- 86° F (15°- 30° C)
  • mfd. in the USA for B.F. Ascher & Co., Inc.

INACTIVE INGREDIENT SECTION

Inactive ingredients: allantoin, aloe vera gel, carbomer, cetyl alcohol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl palmitate, lecithin, mineral oil, potassium sorbate, propylene glycol, sodium benzoate, sodium dehydroacetate, sodium hydroxide, sodium sulfite, stearic acid, sweet almond oil, tetrasodium EDTA, and water

OTC - QUESTIONS SECTION

Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit www.bfascher.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mobisyl 8oz PDPMobisyl 8oz PDPMobisyl 8oz PDP

Mobisyl 3.5oz PDP

Mobisyl 3.5oz PDPMobisyl 3.5oz PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101836Mobisyl 10 % Topical CreamPSN6
313518trolamine salicylate 10 % Topical CreamPSN6
1101836trolamine salicylate 100 MG/ML Topical Cream [Mobisyl]SBD6
313518trolamine salicylate 100 MG/ML Topical CreamSCD6
1101836Mobisyl 10 % Topical CreamSY6
1101836Mobisyl 100 MG/ML Topical CreamSY6
313518trolamine salicylate 10 % Topical CreamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0225-0360-11MOBISYL100 g in 1 TUBECREAM1006
0225-0360-35MOBISYL226.8 g in 1 JARCREAM226.86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0225-0360MOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]6Current NDC, Legacy NDC, 2 package rows20241208_036bff5c-f1f2-23db-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0225-0360-11GM - Gram0225-036011d1b0f0-d6c5-4faa-b64d-709c9520aa5312014-10-03
0225-0360-35GM - Gram0225-0360d3a45252-ecab-401c-8686-b7d665bfb37912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TROLAMINE SALICYLATEACTIVE INGREDIENTH8O4040BHD2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
ALOEINACTIVE INGREDIENTV5VD430YW92
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0225-03600225-0360-35, 0225-0360-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
ALMOND OIL66YXD4DKO9IACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFITEVTK01UQK3GIACT
ALLANTOIN344S277G0ZIACT
CARBOMER 9404Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
STEARIC ACID4ELV7Z65APIACT
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE SALICYLATEH8O4040BHDACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SODIUM BENZOATEOJ245FE5EUIACT

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 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 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
MOBISYLTROLAMINE SALICYLATEBF ASCHER AND CO INC036bff5c-f1f2-23db-e054-00144ff8d46c2024-12-05WarningsExact identifier
ndc (package): 0225-0360-35
ndc (package): 0225-0360-11
ndc (product): 0225-0360
ndc11 (package): 00225036011
ndc11 (package): 00225036035
spl id: 2888aeb6-cb43-3cec-e063-6294a90af425
spl set id: 036bff5c-f1f2-23db-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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