![Arnica Montana 30 [hp_C]/1 Tablet, 250-count — NDC 53499-3571-03 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d96936e2-7356-4404-9617-8c61c87fb5d9&name=21203574_Arnica+montana-30C_05.jpg)
Arnica Montana 30 [hp_C]/1 Tablet, 250-count
by Schwabe North America, Inc. · 250 TABLET in 1 BOTTLE, GLASS (53499-3571-3)
NDC 53499-3571-03
🏷️ FDA NDC (as labeled)
53499-3571-3
billing pads the package segment with a zero
This package
Contains250-count
Pack sizes2 compare ↓
Also comes in:
100 tablets 53499-3571-02
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)
53499-3571-3
Product NDC
53499-3571
11-digit billing NDC
53499357103
UNII
O80TY208ZW
SPL Set ID
d96936e2-7356-4404-9617-8c61c87fb5d9
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2006-01-01
Marketing end
2027-03-31
Route
SUBLINGUAL
Dosage form
TABLET
Substance
ARNICA MONTANA
Why two NDCs?
The FDA registers this code as 53499-3571-3 — a 5-4-1 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 package segment → 53499-3571-03. 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
LabelerSchwabe North America, Inc.
Labeler code53499
First marketedJan 2006
Product typeHuman Otc Drug
Portfolio27 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
🧪 What is this product?
This is a homeopathic tablet taken under the tongue that contains arnica montana. In homeopathic practice, arnica montana is traditionally used to address minor bruising, muscle soreness, and swelling. Homeopathic products are marketed based on traditional use and are not evaluated by the FDA for effectiveness. This product is unapproved by the FDA.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Arnica Montana?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCELLULOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM CROSCARMELLOSE
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 each | 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:
100 tablets
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 |
|---|---|---|---|---|---|---|
| Arnica Montana 30 [hp_C]this 53499-3571-03 | Schwabe | 250 tablets | — | — | FDA listed | — |
| Arnica Montana 30C 30 [hp_C] 61727-0111-10 | Homeocare | 100 tablets | — | — | FDA listed | — |
| Arnica 30C 30 [hp_C] 76472-1129-01 | SEVENE | 80 pellets | — | — | FDA listed | — |
| Arnica Montana 30C - 3-Pack 30 [hp_C] 76472-5000-02 | SEVENE | 3 cylinders | — | — | 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
🏛️
2006
On the market since
Jan 2006
📍
2026
Currently FDA-listed
20 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 53499-3571-02 | 100 TABLET in 1 BOTTLE, GLASS (53499-3571-2) | 2006-01-01 | Active |
| 53499-3571-03 You're viewing this | 250 TABLET in 1 BOTTLE, GLASS (53499-3571-3) | 2006-01-01 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 53499-3571-03?
NDC 53499-3571-03 is a 250-count package — 250 tablet in 1 bottle, glass.
What is the difference between NDC 53499-3571-03 and NDC 53499-3571-02?
Both are Arnica Montana 30 [hp_C]/1 Tablet — the drug itself is identical. NDC 53499-3571-03 is the 250-count package, while NDC 53499-3571-02 is the 100 tablets package.
What NDC number is used to bill for this package of Arnica Montana 30 [hp_C]/1 Tablet?
Bill NDC 53499-3571-03 — the 11-digit billing format is 53499357103. 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
Homeopathic listing
About homeopathic listings
Arnica Montana 30 [hp_C]/1 TABLET is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.
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 "Unapproved Homeopathic". 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 53499-3571-3, 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: 53499-3571-03, written without dashes as 53499357103. 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 53499-3571-03, the first segment (53499) is the labeler code FDA assigned to Schwabe North America, Inc.; the middle segment (3571) 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 it is currently marketed — but Schwabe North America, Inc. has reported a marketing end date of 2027-03-31, after which this package is expected to stop being marketed. 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 tablets (53499-3571-02). 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?
Schwabe North America, 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
⏱️ Dosage and Administration
⚠️ Warnings
🆘 Overdosage
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Indications and Usage Temporarily relieves minor muscle or joint aches and pains from strains, sprains, bruises, backache, over extertion.
⏱️ Dosage and Administration ▾
Dosage and Administration Adults or children over 2 years: Take 3 tablets 1 to 3 times per day. Allow to dissolve under tongue. Indications and Usage Temporarily relieves minor muscle or joint aches and pains from strains, sprains, bruises, backache, over extertion. Purpose For the temporary relief of minor muscle or joint aches and pains from strains, sprains, bruises, backache and over exertion.
⚠️ Warnings ▾
Warnings Do not use this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor.
🆘 Overdosage ▾
Overdose In case of overdose, seek medical help or contact a Posion Control Center immediately.
🧪 Active Ingredient ▾
Active Ingredient Arnica Montana 30C Inactive Ingredients CELLULOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM CROSCARMELLOSE
🧪 Inactive Ingredients ▾
Inactive Ingredients CELLULOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM CROSCARMELLOSE
🎯 Purpose ▾
Purpose For the temporary relief of minor muscle or joint aches and pains from strains, sprains, bruises, backache and over exertion.
No label section mentions that — try another word, or open the full label on DailyMed below.
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.