FDA.reportPublic FDA data

MOBISYL

Product NDC
0225-0360
Requested package NDC
0225-0360-11
11-digit product format
002250360
Labeler code
0225
Product ID
0225-0360_2888aeb6-cb43-3cec-e063-6294a90af425
Type
HUMAN OTC DRUG
Nonproprietary name
TROLAMINE SALICYLATE
Dosage form
CREAM
Route
TOPICAL
Labeler
BF ASCHER AND CO INC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-19
Substance
TROLAMINE SALICYLATE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MOBISYL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROLAMINE SALICYLATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H8O4040BHDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313518Internal RxNorm lookup
1101836Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
036bff5c-f1f2-23db-e054-00144ff8d46cAvailable on FDA.report

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 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROLAMINE SALICYLATEACTIVE INGREDIENTH8O4040BHDMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
ALOEINACTIVE INGREDIENTV5VD430YW9MOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMOBISYL (TROLAMINE SALICYLATE) CREAM [BF ASCHER AND CO INC]2

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

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): 0225-0360-11
ndc (product): 0225-0360
ndc11 (package): 00225036011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101836Mobisyl 10 % Topical CreamPSN036bff5c-f1f2-23db-e054-00144ff8d46c6
313518trolamine salicylate 10 % Topical CreamPSN036bff5c-f1f2-23db-e054-00144ff8d46c6
1101836trolamine salicylate 100 MG/ML Topical Cream [Mobisyl]SBD036bff5c-f1f2-23db-e054-00144ff8d46c6
313518trolamine salicylate 100 MG/ML Topical CreamSCD036bff5c-f1f2-23db-e054-00144ff8d46c6
1101836Mobisyl 10 % Topical CreamSY036bff5c-f1f2-23db-e054-00144ff8d46c6
1101836Mobisyl 100 MG/ML Topical CreamSY036bff5c-f1f2-23db-e054-00144ff8d46c6
313518trolamine salicylate 10 % Topical CreamSY036bff5c-f1f2-23db-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0225-0360-1100225036011100 g in 1 TUBE (0225-0360-11) 100 g2014-09-190000-00-00NoNoCurrent