HomeNDC LookupIngredientsTrolamine Salicylate › 00225-0360-35
MOBISYL TROLAMINE SALICYLATE 10 g/100g Cream, 226.8 g — NDC 00225-0360-35 package photo

MOBISYL TROLAMINE SALICYLATE 10 g/100g Cream, 226.8 g

by BF ASCHER AND CO INC · 226.8 g in 1 JAR (0225-0360-35)
NDC 00225-0360-35
🏷️ FDA NDC (as labeled) 0225-0360-35 billing pads the labeler segment with a zero
This package
Contains226.8 g Pack sizes2 compare ↓
Also comes in: 100 g 00225-0360-11
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0225-0360-35
Product NDC 0225-0360
11-digit billing NDC 00225036035
NCPDP billing unit GM — per gram (weight)
RxCUI 313518, 1101836
UNII H8O4040BHD
Application # 505G(a)(3)
SPL Set ID 036bff5c-f1f2-23db-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-19
Route TOPICAL
Dosage form CREAM
Substance TROLAMINE SALICYLATE
GPI-14 90800080103720
GPI class Mobisyl
GCN Seq No 006137
GCN 24090
HICL code 002637
Ingredient (HICL) Trolamine Salicylate
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 28:08.04.24
AHFS class Salicylates
FDB label name MOBISYL 10% CREAM
FDB brand name Mobisyl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0225-0360-35 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00225-0360-35. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBF ASCHER AND CO INC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code00225
First marketedSep 2014
Product typeHuman Otc Drug
Portfolio7 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MOBISYL 10% CREAM Ingredient Trolamine Salicylate
🧪 What is this product?

Mobisyl Trolamine Salicylate is a topical cream containing trolamine salicylate, an over-the-counter monograph product marketed under established FDA guidelines for its category. Trolamine salicylate is a salt form of salicylate, a compound commonly used in topical products typically applied to the skin for localized discomfort. This cream is meant for external use only and is not individually reviewed by the FDA but follows the monograph standards for salicylate-containing topical products.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 603P14DHEB
    A synthetic antimicrobial chemical used as a preservative in topical and cosmetic formulations. It prevents bacterial and fungal growth in products to maintain stability and safety during storage and use.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII VTK01UQK3G
    Sodium sulfite is a salt preservative derived from sulfur. It prevents discoloration and microbial growth in medicines, helping keep products stable during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

22 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive 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

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pain Relieving 100 mg/g 70000-0744-01 CARDINAL 1 tube $0.034 Availability likely
Mobisyl 10 g/100gthis 00225-0360-35 BF 226.8 g FDA listed
Walgreens Pain Relieving Plus Turmeric Analgesic 100 mg/g 00363-3630-01 Walgreen 1 tube FDA listed
Aspercreme Pain Relieving 10 g/100g 41167-0570-01 Chattem, 1 tube Discontinued
Meijer Analgesic with Aloe Topical Analgesic 100 mg/g 41250-0418-01 Meijer 1 tube FDA listed
Arthritis Relief GoodSense 10 g/100g 50804-0207-03 Geiss, 1 tube FDA listed
Arthritis Cream 10 g/100g 51316-0990-10 CVS 85 g FDA listed
Jointiva 10 g/100g 57237-0355-85 Rising 1 tube FDA listed
Pain Relief Cream 100 mg/g 62742-4091-01 ALLURE 57 g FDA listed
Blue-Emu Maximum Pain Relief .1 g/g 69993-0300-03 Kingsway 88 g FDA listed
Tommie Copper Pain Relief Maximum Strength 10 g/100g 72562-0103-03 Tommie 85 g FDA listed
Tommie Copper Pain Relief 10 g/100g 72562-0223-25 Tommie 70 g FDA listed
Warrior Arthritis Relief 10 g/100g 72839-0213-03 Derma 1 tube FDA listed
DCH Arthritis Relief 10 g/100g 72839-0214-03 Derma 1 tube FDA listed
Equate Odor-Free Therapy Arthritis Analgesic 100 mg/g 79903-0117-01 Wal-Mart 1 tube FDA listed
Dermachange Arthritis Relief 10 g/100g 83520-0214-03 Private 1 tube FDA listed
Hempvana Maximum Strength Pain Relief - Platinum 10 g/100g 73287-0021-01 TELEBRANDS 1 jar FDA listed
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate 10 g/100g 73287-0032-01 TELEBRANDS 1 jar FDA listed
Hempvana Pain Relief 10 g/100g 73287-0001-01 Telebrands 1 jar FDA listed
Hempvana Maximum Strength Pain Relief 10 g/100g 73287-0022-01 TELEBRANDS 1 applicator FDA listed
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate 10 g/100g 73287-0034-01 TELEBRANDS 1 jar FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for MOBISYL (this brand).

Top reported reactions

Nausea8
Diarrhoea7
Dizziness7
Fatigue7
Death5
Arthritis4
Back Pain4

Age at onset

Adult6
Elderly5

Reporter sex

75 reports
Male · 25%
Female · 75%

Serious outcomes

Hospitalization24
Death6
Life-threatening2
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00225-0360-11 100 g in 1 TUBE (0225-0360-11) 2014-09-19 Active
00225-0360-35 You're viewing this 226.8 g in 1 JAR (0225-0360-35) 2014-09-19 Active

Pack size FAQ

What quantity is in NDC 00225-0360-35?
NDC 00225-0360-35 contains 226.8 g — 226.8 g in 1 jar.
What is the difference between NDC 00225-0360-35 and NDC 00225-0360-11?
Both are MOBISYL TROLAMINE SALICYLATE 10 g/100g Cream — the drug itself is identical. NDC 00225-0360-35 is the 226.8 g package, while NDC 00225-0360-11 is the 100 g package.
What NDC number is used to bill for this package of MOBISYL TROLAMINE SALICYLATE 10 g/100g Cream?
Bill NDC 00225-0360-35 — the 11-digit billing format is 00225036035. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0225-0360-35, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00225-0360-35, written without dashes as 00225036035. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00225-0360-35, the first segment (00225) is the labeler code FDA assigned to BF ASCHER AND CO INC; the middle segment (0360) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (35) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BF ASCHER AND CO INC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 g (00225-0360-11). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
BF ASCHER AND CO INC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 24 words

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

⏱️ Dosage and Administration 34 words

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

⚠️ Warnings 9 words

Warnings For external use only. Use only as directed

📦 Storage and Handling 22 words

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

🧪 Active Ingredient 7 words

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

🧪 Inactive Ingredients 44 words

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

🎯 Purpose 22 words

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.