Home › NDC Lookup › Ingredients › Camphor Menthol Methyl Salicylate › 53554-0010-03
Amrutanjan Relief Pain Balm Camphor , Menthol, Methyl Salicylate .1 g/g; .08 g/g; .14 g/g Ointment — NDC 53554-0010-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amrutanjan Relief Pain Balm Camphor , Menthol, Methyl Salicylate .1 g/g; .08 g/g; .14 g/g Ointment — NDC 53554-010-03 (Billing 53554-0010-03)

by AMRUTANJAN HEALTH CARE LIMITED · 1 JAR in 1 BLISTER PACK / 9 g in 1 JAR

This is a package of Amrutanjan Relief Pain Balm Camphor , Menthol, Methyl Salicylate .1 g/g; .08 g/g; .14 g/g Ointment from AMRUTANJAN HEALTH CARE LIMITED, marketed since Jul 2025 and currently FDA-listed. It is the main listing for this product, which comes in 5 package sizes.

NDC 53554-0010-03
🏷️ FDA NDC (as labeled) 53554-010-03 billing pads the product segment with a zero
This package
Contains9 g in 1 jar Pack sizes5 compare ↓
Main listing for product 53554-010 · Also comes in: 30 g 53554-010-05 30 g 53554-010-06 50 g 53554-010-10 50 g 53554-010-11
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53554-010-03
Product NDC 53554-010
11-digit billing NDC 53554001003
RxCUI 1648512
UNII 5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Application # M017
SPL Set ID ddee6714-8b18-4d87-944b-8467fda22e6b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-22
Route TOPICAL
Dosage form OINTMENT
Substance CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Quick answers
  • RxCUI (RxNorm): 1648512
Why two NDCs? The FDA registers this code as 53554-010-03 — 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 → 53554-0010-03. 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.

Clinical

🧪 What is this product?

Amrutanjan Relief Pain Balm is a topical ointment containing camphor, menthol, and methyl salicylate. This is an over-the-counter monograph product, meaning it is marketed under FDA's established category rules for topical pain-relief preparations. The three active ingredients are commonly used together in balms and rubs to create a warming and cooling sensation on the skin, and are typically applied to the surface over areas of minor muscle or joint discomfort.

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.

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: 30 g 30 g 50 g 50 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
53554-0010-03 You're viewing this Main listing 1 JAR in 1 BLISTER PACK / 9 g in 1 JAR 2025-07-22 — Active
53554-0010-05 53554-010-05 1 JAR in 1 CARTON / 30 g in 1 JAR 2025-07-22 — Active
53554-0010-06 53554-010-06 1 BOTTLE, GLASS in 1 CARTON / 30 g in 1 BOTTLE, GLASS 2025-07-22 — Active
53554-0010-10 53554-010-10 1 JAR in 1 CARTON / 50 g in 1 JAR 2025-07-22 — Active
53554-0010-11 53554-010-11 1 BOTTLE, GLASS in 1 CARTON / 50 g in 1 BOTTLE, GLASS 2025-07-22 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 blister pack / 9 g in 1 jar.
What NDC number is used to bill for this package of Amrutanjan Relief Pain Balm Camphor , Menthol, Methyl Salicylate .1 g/g; .08 g/g; .14 g/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amrutanjan Relief Pain Balm .1 g/g; .08 g/g; .14 g/gthis 53554-0010-03 AMRUTANJAN 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII S92U8SQ71V
    A natural oil extracted from cinnamon leaves used as a flavoring agent and fragrance in medicines. It provides taste and aroma to make the product more pleasant to take.
  • UNII QYO8Q067D0
    Citronella oil is a natural plant-derived oil used as a fragrance and flavoring agent in medicines. It provides taste and aroma to make medications more palatable for patients.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 44F3HYL954
    A synthetic yellow dye used to color medicines and supplements. It helps make tablets and capsules visually distinctive for identification and product branding purposes.
  • UNII UP0M8M3VZW
    A fragrant essential oil extracted from lemongrass plants, used primarily as a flavoring and fragrance agent to improve taste and aroma in oral medications.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

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

The official label also statesbutylated hydroxytoluene, cinnamon leaf oil, citronella oil, clove oil, D&C yellow no. 11, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, white petrolatum

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.

Manufacturer & labeler

LabelerAMRUTANJAN HEALTH CARE LIMITED
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code53554
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio2 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.

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

⏱️ Dosage and Administration 71 words ▾

Directions • adults and children over 12 years: Apply gently to the affected area 2-3 times daily, or as directed by a doctor. Do not use more than 3 times daily. • children under 12 years of age: do not use, consult a doctor • this product may cause an allergic reaction in a few individuals. Test on a small area before use • see important warning "When using this product"

⚠️ Warnings 150 words ▾

Warnings For external use only Do not use • on wounds or damaged skin, mucous membranes, broken or irritated skin • near an open flame • otherwise than as directed When using this product • avoid contact with the eyes • do not bandage tightly or use with heating pad • do not microwave • do not heat • do not add to hot water or any container where water is heating. May cause splattering and result in burns. Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches • redness or irritation develops If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 20 words ▾

Other information • store at room temperature • tamper evident: do not purchase if carton seal is broken or tampered

🧪 Active Ingredient 12 words ▾

Active ingredients Camphor 10% w/w Menthol 8% w/w Methyl salicylate 14% w/w

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients butylated hydroxytoluene, cinnamon leaf oil, citronella oil, clove oil, D&C yellow no. 11, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, white petrolatum

🎯 Purpose 3 words ▾

Purpose Pain reliever

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 19 words ▾

Questions? +1-866-799-6929 You may also report serious side effects to this phone number. Mon-Fri 8:00 A.M. - 6:00 P.M.

📄 Package Label / Principal Display Panel 3 words ▾

Packaging Relief Painbalm

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

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 CAMPHOR , MENTHOL, METHYL SALICYLATE — the ingredient across all brands.

Top reported reactions

Application Site Burn6
Application Site Pain6
Chemical Injury4
Erythema3
Malaise3
Pain3
Rash3

Reporter sex

49 reports

Serious outcomes

Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 AMRUTANJAN HEALTH CARE LIMITED. 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 4 other package presentations of this same product, including 1 jar (53554-0010-05), 1 bottle (53554-0010-06), 1 jar (53554-0010-10). 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?
AMRUTANJAN HEALTH CARE LIMITED 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.
← 53511-0004-01 · Volunteer 53554-0020-05 · AMRUTANJAN →
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.