NDC 57896-0116-03 — Analgesic Balm Menthol 10%, Methyl Salicylate

🆔 Identity & classification

FDA NDC (as labeled) 57896-116-03

Product NDC 57896-116

11-digit billing NDC 57896011603

NCPDP billing unit GM — per gram (weight)

RxCUI 311498

UNII L7T10EIP3A, LAV5U5022Y

Application # M017

SPL Set ID ab9bf09d-bc8c-6d17-e053-2995a90a6c36

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-08-05

Route TOPICAL

Dosage form CREAM

Substance MENTHOL; METHYL SALICYLATE

GPI-14 90809902603700

GPI class Analgesic Balm

GCN Seq No 061801

GCN 97586

HICL code 002583

Ingredient (HICL) Methyl Salicylate/Menthol

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 ANALGESIC BALM 15%-10% CREAM

FDB brand name Analgesic Balm

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 57896-116-03 — a 5-3-2 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 product segment → 57896-0116-03. 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

LabelerGeri-Care Pharmaceuticals, Corp

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code57896

First marketedAug 2020

Product typeHuman Otc Drug

Portfolio47 products on file

🔎 All NDCs from Geri-Care Pharmaceuticals, Corp

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 ANALGESIC BALM 15%-10% CREAM Ingredient Methyl Salicylate/Menthol

📗 Our plain-language guide HelloPharmacist

These products are designed for temporary relief of mild to moderate muscle and joint pain — things like arthritis, a sore back, sprains, strains, bruises, and cramps. Medistik Dua...
What kinds of pain does this actually help with?
A mild burning or warming sensation right after you apply it is completely normal and is actually expected. It usually fades within a few days of regular use. What you should NOT i...
I feel a burning sensation after I put it on — is that normal?

📖 Read our full Menthol / Methyl Salicylate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 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 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 A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety 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 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
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.

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

The official label also statesCarbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

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 DailyMed — ingredient 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 system	Per g	Per 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: 28 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 00536-1349-57	Rugby	1 tube	$0.036	—	Availability likely	—
Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g 11527-0057-40	Sheffield	1 tube	—	—	FDA listed	—
Arthritis Hot 10 g/100g; 15 g/100g 41167-0600-03	Chattem,	1 tube	—	—	FDA listed	—
CVS Muscle Rub 150 mg/g; 100 mg/g 51316-0994-03	CVS	85 g	—	—	FDA listed	—
CAREALL Muscle Rub Ultra Strength 100 mg/g; 150 mg/g 51824-0007-03	New	85 g	—	—	FDA listed	—
CAREALL Muscle Rub Ultra Strength 100 mg/g; 150 mg/g 51824-0105-03	New	85 g	—	—	FDA listed	—
Analgesic Balm 10 g/100g; 15 g/100gthis 57896-0116-03	Geri-Care	1 tube	—	—	FDA listed	—
DynaRub 10 g/100g; 15 g/100g 67777-0113-50	Dynarex	72 tubes	—	—	FDA listed	—
Dr Sheffield Muscle Rub Cream 100 mg/g; 150 mg/g 68071-1624-05	NuCare	35 g	—	—	FDA listed	—
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 68071-3789-03	NuCare	1 tube	—	—	FDA listed	—
Muscle Rub Cream 10 g/100g; 15 g/100g 68788-8544-08	Preferred	1 tube	—	—	FDA listed	—
Rugby Muscle Rub Cream 100 mg/g; 150 mg/g 68788-8729-08	Preferred	1 tube	—	—	FDA listed	—
Muscle Rub Cream .1 g/100g; .15 g/100g 69396-0024-05	Trifecta	1 tube	—	—	FDA listed	—
Muscle Rub Cream 10 g/100g; 15 g/100g 69396-0110-30	Trifecta	1 tube	—	—	FDA listed	—
Pain Reliever Cream 10 g/100g; 15 g/100g 69396-0151-01	Trifecta	1 tube	—	—	FDA listed	—
TheraCare Muscle and Join Pain Relieving Cream 100 mg/g; 150 mg/g 71101-0012-01	Veridian	1 tube	—	—	FDA listed	—
AsperFlex 100 mg/g; 150 mg/g 71399-6854-03	Akron	85 g	—	—	FDA listed	—
Calypxo HP Pain Relief 15 g/100g; 10 g/100g 76420-0999-01	Asclemed	113 g	—	—	FDA listed	—
Muscle Rub 10 g/100g; 15 g/100g 87236-0005-01	Aldermed	1 tube	—	—	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

🏛️

2020

On the market since

Aug 2020

📍

2026

Currently FDA-listed

6 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 Analgesic Balm (this brand).

Top reported reactions

Difficulty In Walking2

Vision Blurred2

Weight Decreased2

Abdominal Discomfort1

Abdominal Pain Upper1

Alanine Aminotransferase Increased1

Anorexia1

Reporter sex

Male · 44%

Female · 56%

Serious outcomes

Hospitalization4

Life-threatening1

Disabling1

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
57896-0116-01	1 TUBE in 1 BOX (57896-116-01) / 28 g in 1 TUBE	2020-08-05	Active
57896-0116-03 You're viewing this	1 TUBE in 1 BOX (57896-116-03) / 85 g in 1 TUBE	2021-08-02	Active

Pack size FAQ

What quantity is in NDC 57896-0116-03?

NDC 57896-0116-03 is listed by the FDA — 1 tube in 1 box / 85 g in 1 tube.

What NDC number is used to bill for this package of Analgesic Balm Menthol 10%, Methyl Salicylate 15% 10 g/100g; 15 g/100g Cream?

Bill NDC 57896-0116-03 — the 11-digit billing format is 57896011603. 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 57896-116-03, 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: 57896-0116-03, written without dashes as 57896011603. 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 57896-0116-03, the first segment (57896) is the labeler code FDA assigned to Geri-Care Pharmaceuticals, Corp; the middle segment (0116) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Geri-Care Pharmaceuticals, Corp. 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 1 tube (57896-0116-01). 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?

Geri-Care Pharmaceuticals, Corp 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 22 words ▾

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

⏱️ Dosage and Administration 45 words ▾

Directions Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age. consult a doctor Unless treating hands, wash hands thoroughly with soap and water immediately after use.

⚠️ Warnings 59 words ▾

Warnings For external use only Do not use: On wounds or damaged, broken or irritated skin On a child under 12 years of age with arthritis-like conditions With a heating pad Ask a doctor before use if you have redness over the affected area. When using this product Avoid contact with eyes or mucous membrane Do not bandage tightly

📦 Storage and Handling 13 words ▾

Other Information Store at controlled room temperature 20º-25ºC (68º-77ºF) Questions ? Call 1-800-540-3765

🧪 Active Ingredient 9 words ▾

Active Ingredient Menthol 10%

Active Ingredient Methyl Salicylate 15%

🧪 Inactive Ingredients 18 words ▾

Inactive Ingredients Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

🎯 Purpose 2 words ▾

Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Menthol 10%, Methyl Salicylate 15% NDCsSame ingredient 🏭 All Geri-Care labeler NDCsLabeler code 57896

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Irritants/Counter-Irritants.

Coal Tar 00096-0736-08 Eucalyptus/Me-Sal/Men/Camp/Ipa 00219-0203-80 Capsaicin 00536-1118-25 Capsaicin/Me-Salicylate/Menth 27495-0014-02 Methyl Salicylate/Menth/Camph 46122-0392-58 Eucalypt/Men/Camph/Turp/Wh.pet 49348-0398-96 Balsam Peru/Zinc Oxide 54323-0215-02 Cantharidin 71349-0070-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.