Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
SALONPAS-HOT CAPSICUM Capsaicin .025 g/100g Patch — NDC 46581-700-03 (Billing 46581-0700-03)
by Hisamitsu Pharmaceutical Co., Inc. · 3 PATCH in 1 POUCH / 4 g in 1 PATCH
This is a package of SALONPAS-HOT CAPSICUM Capsaicin .025 g/100g Patch from Hisamitsu Pharmaceutical Co., Inc., marketed since Nov 1998 and currently FDA-listed.
NDC 46581-0700-03
🏷️ FDA NDC (as labeled)
46581-700-03
billing pads the product segment with a zero
This package
Contains4 g in 1 patch
Pack sizes2 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 46581-700-03 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 46581 labeler · 700 product · 03 package
- Package marketed since
- Dec 1, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 4658170003 9
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
46581-700-03
Product NDC
46581-700
11-digit billing NDC
46581070003
NCPDP billing unit
EA — each (per item)
RxCUI
1043399
UNII
00UK7646FG
Application #
M017
SPL Set ID
ef5373aa-9857-4d01-95af-2d7716e54ae4
Established class (EPC)
Non-Standardized Plant Allergenic Extract; Non-Standardized Food Allergenic Extract
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity
Chemical class
Allergens; Dietary Proteins; Plant Proteins; Vegetable Proteins
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1998-11-26
Route
TOPICAL
Dosage form
PATCH
Substance
CAPSICUM
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90850025005920
GPI class
Salonpas-Hot
GCN Seq No
022813
GCN
33562
HICL code
002577
Ingredient (HICL)
Capsaicin
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
84:92.00.00
AHFS class
Skin And Mucous Membrane Agents, Misc.
FDB label name
SALONPAS-HOT 0.025% PATCH
FDB brand name
Salonpas-Hot
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 022813
- GCN: 33562
- GPI-14 (Medi-Span): 90850025005920
- HICL (First Databank): 002577
- AHFS class code: 84:92.00.00
- RxCUI (RxNorm): 1043399
Why two NDCs?
The FDA registers this code as 46581-700-03 — 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 → 46581-0700-03. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Capsaicin and similar agents class.
Drug family (ATC)
Capsaicin and similar agents, Other local anesthetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name SALONPAS-HOT 0.025% PATCH Ingredient Capsaicin
📖 What it is MedlinePlus · NLM
Capsaicin topical system is used to treat neuropathic pain from postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles) or from diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes). Capsaicin is a substance that is found in chili peppers. Capsaicin topical system is in a class of medications called topical pain relievers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Yes, completely normal — and it actually means the medicine is working. Capsaicin activates the same pain-sensing receptors in your skin that respond to heat and spicy food. That b...
- Why does capsaicin burn when I put it on? Is that normal?
- For most OTC creams and ointments, you can apply up to 3 to 4 times a day. For OTC patches, apply to clean, dry skin and remove after no more than 8 hours — again, up to 3 to 4 tim...
- How often should I apply capsaicin cream or use the patch?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Capsaicin (prescription drug) — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Capsaicin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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:
4 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 46581-0700-01 46581-700-01 Main listing | 1 PATCH in 1 POUCH / 4 g in 1 PATCH | 1998-11-26 | — | Discontinued by firm |
| 46581-0700-03 You're viewing this | 3 PATCH in 1 POUCH / 4 g in 1 PATCH | 2018-12-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 3 patch in 1 pouch / 4 g in 1 patch.
What NDC number is used to bill for this package of SALONPAS-HOT CAPSICUM Capsaicin .025 g/100g Patch?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Neighbor Capsaicin Heat Patch for Back .025 g/100g 46122-0753-55 | Amerisource | 3 patches | $1.117 | — | Availability likely | — |
| Capsaicin Hot Patches .025 g/100g 70000-0556-01 | Cardinal | 2 patches | $1.117 | — | Availability likely | — |
| Capsimide .025 g/100g 70512-0016-10 | Sola | 10 pouches | $1.117 | — | Availability likely | — |
| Walgreens Capsaicin Hot Patch .25 mg/g 00363-6691-03 | Walgreen | 3 patches | — | — | FDA listed | — |
| Capsaicin Heat Patches Back And Large Areas .025 g/100g 00363-9902-03 | Walgreen | 3 patches | — | — | FDA listed | — |
| WellPatch Warming Pain Relief 25 mg 10742-8127-01 | The | 1 patch | — | — | FDA listed | — |
| Capsaicin Heat Patches Pain Relief .025 g/100g 11822-4210-03 | Rite | 3 patches | — | — | FDA listed | — |
| Capsaicin Heat Patches Back And Large Areas .025 g/100g 41250-0842-03 | Meijer | 3 patches | — | — | FDA listed | — |
| Salonpas-Hot Capsicum .025 g/100gthis 46581-0700-03 | Hisamitsu | 3 patches | — | — | FDA listed | — |
| Equate Capsaicin Pain Relieving .25 mg/g 49035-0890-01 | Wal-Mart | 1 patch | — | — | FDA listed | — |
| Satogesic Hot .25 mg 49873-0608-01 | Sato | 5 patches | — | — | FDA listed | — |
| Capsaicin .025 g/100g 50488-2025-01 | Alexso, | 10 patches | — | — | FDA listed | — |
| Capsaicin Heat .025 g/100g 52000-0040-41 | Universal | 2 patches | — | — | FDA listed | — |
| Solstice Capsaicin Patch Hot .025 g/100g 55614-0410-01 | MADISON | 1 patch | — | — | FDA listed | — |
| CVS Medicated Heat 1 ct .025 g/g 59779-0770-01 | CVS | 1 g | — | — | FDA listed | — |
| Best Choice Targeted Warming Capsaicin Heat Patch .025 g/100g 63941-0691-03 | Valu | 3 patches | — | — | FDA listed | — |
| Coralite Medicated Heat 249 mg 65923-0123-01 | United | 1 patch | — | — | FDA listed | — |
| Coralite Capsaicin Heat Patch 2ct 249 mg/g 65923-0809-02 | United | 1 patch | — | — | FDA listed | — |
| Capsaicin Pain Relief .702 mg 67510-0303-01 | Kareway | 1 patch | — | — | FDA listed | — |
| Capsaicin .025 g/100g 69420-7025-01 | SA3, | 10 patches | — | — | FDA listed | — |
| Capsaicin .025 g/100g 71436-3025-01 | ARI | 10 patches | — | — | FDA listed | — |
| Pain Relieving Gel-Patch .00025 g/g 73557-0180-05 | Shanghai | 5 patches | — | — | FDA listed | — |
| BonicaEaseX Hot Capsicum Pain Relieving .25 mg 75568-0042-00 | Planet | 24 patches | — | — | FDA listed | — |
| Meijer Capsaicin Heat Patch .025 g/100g 79481-0064-03 | Meijer | 3 patches | — | — | FDA listed | — |
| Capsaicin .025 g/100g 79643-0002-01 | PHARMACURE | 10 patches | — | — | FDA listed | — |
| Capsaicin 0.025% 2.5 mg/10g 80425-0541-01 | Advanced | 30 patches | — | — | FDA listed | — |
| CAPSAICIN HEAT Patch .025 g/1001 83559-0013-01 | Henan | 48 patches | — | — | FDA listed | — |
| Rapid Relief .00025 g/g 83569-0018-06 | RAPID | 6 patches | — | — | FDA listed | — |
| Honest Med Capsaicin Patch .025 g/100g 84097-0003-24 | Proper | 24 patches | — | — | FDA listed | — |
| Capsaicin 0.025% 2.5 mg/10g 85096-0401-30 | Marcella | 30 patches | — | — | FDA listed | — |
| 0.025% Capsaicin Pain relief Patch .025 g/100g 85323-0001-00 | Xuzhou | 5 patches | — | — | FDA listed | — |
| 0.025% Capsaicin Pain relief Patch .025 g/100g 85323-0005-01 | Xuzhou | 48 patches | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
1998
On the market since
Nov 1998
📍
2026
Currently FDA-listed
28 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 2LQ0UUW8IN
A natural rubber material derived from the rubber tree. It's used as a coating or component in capsule shells and drug delivery devices to provide structure, flexibility, and controlled release of the medication.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
UNII SOI2LOH54Z
Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbutylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerHisamitsu Pharmaceutical Co., Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code46581
First marketedNov 1998
Product typeHuman Otc Drug
Portfolio11 products on file
More NDCs from Hisamitsu Pharmaceutical Co., Inc. labeler code 46581
- Salonpas Camphor, Menthol, Methyl salicylate 86.24 mg; 166.92 mg; 278.2 mg Patch NDC 46581-210-06
- Salonpas pain relieving JET Menthol, Methyl salicylate 3 g/100g; 10 g/100g Aerosol, Spray NDC 46581-440-04
- Salonpas Pain Relief Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch NDC 46581-670-01
- Salonpas Pain Relief Menthol, Methyl Salicylate 63 mg; 210 mg Patch NDC 46581-675-01
- Salonpas Arthritis Pain Menthol, Methyl Salicylate 31.5 mg; 105 mg Patch NDC 46581-680-01
- Salonpas Arthritis Pain Menthol, Methyl Salicylate 63 mg; 210 mg Patch NDC 46581-685-09
- Salonpas LIDOCAINE Pain Relieving 560 mg Patch NDC 46581-830-01
- Salonpas Pain Relieving LIDOCAINE 4% FLEX 42 mg Patch NDC 46581-840-07
- Salonpas pain relieving hot Capsaicin, Menthol .025 g/100g; 1.25 g/100g Patch NDC 46581-871-06
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years of age and over: clean and dry affected area remove patch from film apply to affected area not more than 3 to 4 times daily remove patch from the skin after at most 8 hours' application Children under 12 years of age: consult a doctor
⚠️ Warnings ▾
Warnings For external use only Do not use on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower Stop use and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days 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 ▾
Other information Avoid storing product in direct sunlight Protect product from excessive moisture
🧪 Active Ingredient ▾
Active ingredient Capsicum extract 0.025% as Capsaicin
🧪 Inactive Ingredients ▾
Inactive ingredients butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide
🎯 Purpose ▾
Purpose Topical analgesic
📄 Do Not Use ▾
Do not use on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower
📄 When Using This Product ▾
When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? Toll free 1-800-826-8861 www.salonpas.us
📄 Package Label / Principal Display Panel ▾
Principal Display Panel 3 LARGE FOLDED PATCHES 5.12" X 7.09"(13 cm X 18 cm) OTC topical analgesics in patch category* WORLD'S BRAND NO.1 Hisamitsu NDC#46581-700-03 for temporary relief of minor aches and pains of muscles and joints associated with Simple backache Arthritis Strains Bruises Sprains Salonpas-HOT CAPSICUM Patch Topical Analgesic 3 FOLDED PATCHES 5.12" X 7.09" (13cm X 18cm) MADE IN JAPAN image description
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 ↗
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 SALONPAS-HOT CAPSICUM (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 43%
Female · 56%
Unknown · 0%
Serious outcomes
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.
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 Hisamitsu Pharmaceutical 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 1 patch (46581-0700-01). 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?
Hisamitsu Pharmaceutical 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.
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.