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Salonpas Diclofenac Sodium 10 mg/g Gel — NDC 55328-801-10 (Billing 55328-0801-10)

by Hisamitsu America, Inc. · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Salonpas Diclofenac Sodium 10 mg/g Gel from Hisamitsu America, Inc., marketed since Mar 2016 and currently FDA-listed. It is this product's only package size.

NDC 55328-0801-10
🏷️ FDA NDC (as labeled) 55328-801-10 billing pads the product segment with a zero
OTC Generic 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

⚠️
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 27, 2026 — Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0342-2026
Class III · Dec 22, 2025 — Failed PH Specifications (Cipla USA, Inc.) · FDA recall D-0291-2026
Class II · Jun 22, 2023 — Defective Delivery System (ALEMBIC PHARMACEUTICALS, INC.) · FDA recall D-0941-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55328-801-10
Product NDC 55328-801
11-digit billing NDC 55328080110
RxCUI 855633
UNII QTG126297Q
Application # ANDA208077
SPL Set ID f439445d-046e-4220-a4a7-13d750ee0949
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-03-21
Route TOPICAL
Dosage form GEL
Substance DICLOFENAC SODIUM
Quick answers
  • RxCUI (RxNorm): 855633
Why two NDCs? The FDA registers this code as 55328-801-10 — 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 → 55328-0801-10. 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.

RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors
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.

Clinical

📖 What it is MedlinePlus · NLM

Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph e...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your produ...
  • Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb,...
  • Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your docto...
  • Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new ra...
📖 Read our full Diclofenac guide →
1
Nutrient depletion considerations

Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diclofenac Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
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
55328-0801-10 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2016-03-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense arthritis pain 10 mg/g 00113-1189-01 L. 1 tube $0.081 — Availability likely —
Good Sense Arthritis Pain 10 mg/g 00113-8175-01 L. 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 45802-0953-01 Padagis 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 68001-0621-45 BluePoint 1 tube $0.081 — Availability likely —
Diclofenac sodium 10 mg/g 69097-0720-44 Cipla 1 tube $0.081 — Availability likely —
Diclofenac sodium 10 mg/g 69238-2053-01 Amneal 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 70512-0106-10 SOLA 1 tube $0.081 — Availability likely —
Arthritis Pain 10 mg/g 70677-1125-01 Strategic 1 tube $0.081 — Availability likely —
Foster And Thrive Arthritis Pain 10 mg/g 70677-1293-01 Strategic 1 tube $0.081 — Availability likely —
Diclofenac Sodium 10 mg/g 76282-0103-39 EXELAN 1 tube $0.081 — Availability likely —
Arthritis Pain Reliever 10 mg/g 83324-0306-01 QUALITY 1 tube $0.081 — Availability likely —
Arthritis Pain Reliever 10 mg/g 46122-0752-37 AmerisourceBergen 1 tube $0.117 — Availability likely —
Diclofenac sodium 10 mg/g 70000-0555-01 CARDINAL 1 tube $0.117 — Availability likely —
Voltaren Arthritis Pain 10 mg/g 00067-8152-01 Haleon 1 tube — — FDA listed —
Voltaren Arthritis Pain 00067-8153-01 Haleon 1 kit — — FDA listed —
Voltaren Arthritis Pain 00067-8154-01 Haleon 1 kit — — FDA listed —
Aleve Arthritis Pain Gel 1 mg/g 00280-0039-01 Bayer 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 00363-1210-17 Walgreens 1 tube — — FDA listed —
Arthritis Pain Relieving 10 mg/g 00363-3003-02 Walgreen 1 tube — — FDA listed —
arthritis pain relieving 10 mg/g 00363-5123-01 Walgreen 1 tube — — Discontinued —
Diclofenac Sodium Topical Gel 1% 10 mg/g 00363-7065-10 Walgreens 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 00536-1294-31 Rugby 1 tube — — FDA listed —
up and up arthritis pain reliever 10 mg/g 11673-0569-01 Target 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 11822-0870-01 Rite 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 21130-0028-10 Safeway, 1 tube — — FDA listed —
signature care arthritis pain 10 mg/g 21130-0313-01 Safeway 1 tube — — Discontinued —
Diclofenac Sodium 10 mg/g 21922-0044-29 Encube 1 tube — — Discontinued —
Diclofenac Sodium Topical Gel 1% 10 mg/g 30142-0025-10 Kroger 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 30142-0277-10 KROGER 1 tube — — FDA listed —
topcare athritis pain reliever 10 mg/g 36800-0526-01 Topco 1 tube — — FDA listed —
arthritis pain reliever 10 mg/g 37808-0087-01 H 1 tube — — FDA listed —
equaline arthritis pain relieving 10 mg/g 41163-0087-01 United 1 tube — — FDA listed —
Aspercreme Arthritis .01 g/g 41167-0571-00 Chattem, 1 tube — — FDA listed —
Aspercreme Arthritis .01 g/g 41167-0573-02 Chattem, 1 tube — — FDA listed —
arthritis pain relieving 10 mg/g 41250-0674-01 Meijer 1 tube — — FDA listed —
CareOne arthritis pain relief 10 mg/g 41520-0788-01 American 1 tube — — FDA listed —
arthritis pain reliever 10 mg/g 42507-0150-01 HyVee 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 43598-0885-10 Dr. 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 43598-0977-05 Dr. 1 tube — — FDA listed —
equate arthritis pain 10 mg/g 49035-0262-01 Wal-Mart 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 49035-0269-17 EQUATE 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 50090-4020-00 A-S 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 50090-4030-00 A-S 1 tube — — FDA listed —
Voltaren Arthritis Pain 10 mg/g 50090-6202-00 A-S 24 tubes — — Discontinued —
Diclofenac Sodium 10 mg/g 50090-6998-00 A-S 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 50090-7243-00 A-S 1 tube — — FDA listed —
good sense arthritis pain 10 mg/g 50090-7250-00 A-S 1 tube — — FDA listed —
Motrin Arthritis Pain 9.3 mg/g 50580-0574-01 Kenvue 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 51316-0012-15 CVS 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 51316-0073-76 CVS 1 tube — — FDA listed —
Diclofenac Sodium Topical 10 mg/g 51316-0804-01 CVS 1 tube — — FDA listed —
Arthritis Pain 10 mg/g 53943-0523-01 Discount 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 55319-0969-17 Family 1 tube — — FDA listed —
Salonpas 10 mg/gthis 55328-0801-10 Hisamitsu 1 tube — — FDA listed —
DG health arthritis pain 10 mg/g 55910-0424-02 Dolgencorp 1 tube — — FDA listed —
Dg Health Arthritis Pain 10 mg/g 55910-0926-50 Dolgencorp 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 56062-0471-02 Publix 1 tube — — FDA listed —
arthritis pain reliever 10 mg/g 56062-0878-01 Publix 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 57483-0185-11 INNOVUS 1 tube — — FDA listed —
Crcle Diclofenac Sodium Topical Gel 1% 10 mg/g 57483-0596-01 Innovus 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 57896-0140-01 GERI-CARE 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 57896-0147-01 GERI-CARE 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 58602-0604-07 Aurohealth 1 tube — — FDA listed —
Diclofenac Sodium 58602-0606-21 Aurohealth 1 kit — — FDA listed —
Diclofenac Sodium 10 mg/g 58602-0609-07 Aurohealth 1 tube — — FDA listed —
VennGel One 59088-0709-00 PureTek 1 kit — — FDA listed —
Arthritis Pain Reliever 10 mg/g 59640-0198-01 H 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 59726-0012-50 P 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 62379-0401-02 Simple 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 63187-0753-00 Proficient 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 63868-0730-01 Chain 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 63941-0812-53 Best 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 63981-0112-15 Costco 3 tubes — — Discontinued —
Diclofenac sodium 10 mg/g 63981-0211-15 Costco 3 tubes — — FDA listed —
kirkland signature arthritis pain relief 10 mg/g 63981-0599-05 Costco 3 tubes — — FDA listed —
kirkland signature arthritis pain relief 10 mg/g 63981-0799-05 Costco 3 tubes — — FDA listed —
Diclofenac Sodium 10 mg/g 67296-2155-01 Redpharm 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 68016-0171-00 Chain 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68071-2239-01 NuCare 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68071-3456-01 NuCare 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68071-3665-01 NuCare 1 tube — — FDA listed —
diclofenac sodium 10 mg/g 68071-3671-01 NuCare 1 tube — — FDA listed —
Members Mark Arthritis Pain Reliever 10 mg/g 68196-0523-05 Sam's 3 tubes — — FDA listed —
members mark arthritis pain reliever 10 mg/g 68196-0870-05 Sam's 3 tubes — — FDA listed —
berkley and jensen arthritis pain 68391-0205-00 BJWC 1 kit — — FDA listed —
Diclofenac Sodium 10 mg/g 68788-7772-01 Preferred 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 69842-0729-01 CVS 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 69842-0974-06 CVS 2 tubes — — FDA listed —
Diclofenac Sodium 10 mg/g 71205-0552-00 Proficient 1 tube — — FDA listed —
good sense arthritis pain 10 mg/g 71205-0670-00 Proficient 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 71205-0747-00 Proficient 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 72036-0014-10 Harris 1 tube — — FDA listed —
Gencare-Arthritis Pain Relief .01 g/g 72090-0017-01 Pioneer 1 tube — — FDA listed —
Diclofenac Sodium Gel 10 mg/g 72189-0479-01 Direct_Rx 1 g — — FDA listed —
Amazon Basic Care Arthritis Pain 10 mg/g 72288-0624-03 Amazon.com 1 tube — — FDA listed —
basic care arthritis pain 10 mg/g 72288-0870-01 Amazon.com 1 tube — — FDA listed —
Arthritis Pain Reliever 10 mg/g 72476-0212-17 Care 1 tube — — Discontinued —
Curist Arthritis Relief 1 g/100g 72559-0020-24 Little 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 73469-2053-01 Scholl's 1 tube — — FDA listed —
Diclofenac Sodium Topical 1% 1 mg/100g 73581-0104-15 YYBA 1 tube — — FDA listed —
Diclofenac Sodium Topical Gel, 1% 1 g/100g 73715-0005-01 Mohnark 50 g — — Discontinued —
Topcare Arthritis Pain Reliever 10 mg/g 76162-0804-01 Topco 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 76420-0091-01 Asclemed 100 g — — FDA listed —
Diclofenac Sodium 10 mg/g 76420-0691-01 Asclemed 1 tube — — FDA listed —
Arthritis Pain Relieving 10 mg/g 79481-0499-00 Meijer, 1 tube — — FDA listed —
Equate Arthritis Pain 10 mg/g 79903-0391-01 WALMART 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 80425-0233-01 Advanced 1 tube — — FDA listed —
Up And Up Arthritis Pain Reliever 10 mg/g 82442-0251-01 Target 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 83008-0037-00 Quality 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 84386-0120-01 Aurobindo 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 85766-0136-01 Sportpharm 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 85766-0137-01 Sportpharm 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 85766-0160-01 Sportpharm 1 tube — — FDA listed —
Arthritis Pain Relief 10 mg/g 51316-0517-00 CVS 2 tubes — — FDA listed —
Diclofenac Sodium 10 mg/g 68788-4335-01 Preferred 1 tube — — FDA listed —
Diclofenac sodium 10 mg/g 68071-5307-01 NuCare 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 68788-4135-01 Preferred 1 tube — — FDA listed —
Diclofenac 10 mg/g 73581-0410-01 YYBA 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 11673-0028-10 Target 1 tube — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 America, Inc.
Application holderAMNEAL PHARMACEUTICALS
FDA applicationANDA208077 (ANDA)
Labeler code55328
First marketedMar 2016
Product typeHuman Otc Drug
Portfolio5 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 💬 Medication Guide 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 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 57 words ▾

Use(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body areas)  this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

⏱️ Dosage and Administration 182 words ▾

Directions Use up to 21 days unless directed by your doctor. Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.

Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areasat the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle, or knee) Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same areas as any other product do not apply with external heat such as a heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%.

The dosing card is re-usable.

⚠️ Warnings ~3 min read ▾

Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reacction, expecially in people allergic to aspirin. Symptoms may include:  hives  asthma (wheezing)  skin reddening  blisters  facial swelling  shock  rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac.

Liver damage may occur if you apply:  more or for a longer time than directed  when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you:  are age 60 or older  have had stomach ulcers or bleeding problems  take a blood thinning (anticoagulant) or steroid drug  take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)  have 3 or more alcoholic drinks every dday while using this product  apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use  if you have ever had an allergic reaction to any other pain reliever or to a fever reducer  for strains, sprains, bruises or sports injuries.

This product has not been shown to work for these types of injuries.  right before or after heart surgery  on more than 2 body areas at the same time  in the eyes, nose or mouth Ask a doctor before use if  you have problems or serious side effects from taking pain relievers or fever reducers  stomach bleeding warning applies to you  you have a history of stomach problems, such as heartburn  you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke  you are taking a diuretic  you are under the age of 18 years.

It is not known if this drug works or is safe in children under the age of 18 years. Ask a doctor or pharmacist before use if  under a doctor’s care for any serious condition  taking any other drug When using this product  avoid contact with eyes, nose, or mouth  if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if  pain gets worse or lasts more than 21 days  redness or swelling is present in the painful area  fever occurs  skin irritation occurs  any new symptoms appear. These could be signs of a serious condition.  you experience any of the following signs of stomach bleeding:  feel faint  have bloody or black stools  vomit blood  have stomach pain that does not get better  you have symptoms of heart problems or stroke:  chest pain  trouble breathing  leg swelling  weakness in one part of side of body  slurred speech Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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.

📦 Storage and Handling 13 words ▾

Storage  store at 20˚ to 25˚C (68˚ to 77˚F). Keep from freezing.

🧪 Active Ingredient 13 words ▾

Active ingredient(s) Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

🎯 Purpose 4 words ▾

Purpose Arthritis pain reliever

💬 Medication Guide ~3 min read ▾

Diclofenac sodium topical gel, 1% (NSAID) - arthritis pain reliever Salonpas Arthritis Pain Relief Gel Diclofenac Sodium Topical Gel, 1% (NSAID) Arthritis Pain Reliever User Guide How to use diclofenac sodium topical gel, with answers to frequently asked questions Quick Start How to get started right away with diclofenac sodium topical gel Unserstanding diclofenac sodium topical gel Diclofenac sodium topical gel, 1% ( NSAID ) - arthritis pain reliever is an arthritis pain relief medication that you apply to your skin.

Before You Use Diclofenac Sodium Topical Gel Read the Drug Facts Label, which appears on the carton. Remove the dosing card from the inside of the carton. You should always use the dosing card to measure out the correct dose of diclofenac sodium topical gel.

The first time you use a tube of diclofenac sodium topical gel: 1. Take the cap off the tube. Open the foil seal that covers the tube opening by using the spiked top of the cap.

2. Firmly press the cap to remove the safety seal. Do not open the safety seal with the scissors or other sharp objects.

3. After use, put the cap back on the end of the tube. Using diclofenac sodium topical gel How often to use diclofenac sodium topical gel Use 4 times a day for best results.

For example: Where to apply diclofenac sodium topical gel Diclofenac sodium topical gel can be used on up to 2 body areas from the following list: a hand, a wrist, an elbow, a foot, an ankle, a knee. Do not use on more than 2 body areas at once. Some examples include: Measuring the correct amount using the dosing card For each upper body area (a hand, a wrist, or an elbow): Squeeze gel from the tube equal to the length shown on the upper body section of the dosing card (2.25 inches).

For each lower body area (a foot, an ankle, or a knee): Squeeze gel from the tube equal to the length shown on the lower body section of the dosing card (4.5 inches). Lost Your Dosing Card” Don’t worry! Call 1-800-826-8861 to get a free replacement.

Applying diclofenac sodium topical gel Gently rub diclofenac sodium topical gel into the skin using your hand. Apply 4 times a day for best results. Do not use on more than 2 body areas at once.

Apply only to clean, dry skin that doesn’t have any cuts, open wounds, infections or rashes. Do not apply in the same area as any other medicines or products that are applied to the skin. After You Use diclofenac sodium topical gel Wash your hands after applying diclofenac sodium topical gel.

If the treated area is the hands wait up to 1 hour to wash the hands. Wash the dosing card with water. Store dosing card with your diclofenac sodium topical gel and keep out of reach of children.

Wait ten minutes before covering the treated areas with clothes or gloves. Avoid: showering or bathing for at least 1 hour after use exposing the treated area to sunlight or artificial light (such as tanning booths) use in the same area as other products applied to the skin applying a bandage over the treated area eye, nose, or mouth contact if eye contact occurs, rinse thoroughly with water Facts you need to know Important information about diclofenac sodium topical gel Do not use diclofenac sodium topical gel… if you have ever had an allergic reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries.

This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in the eyes, nose or mouth Ask a doctor before use is… you have problems or side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you are under age 18 years.

It is not known if this drug works or is safe in children under age 18 years. Ask a doctor or pharmacist before use if… you ar… [Excerpted — this section continues on DailyMed.]

📄 Do Not Use 68 words ▾

Do not use  if you have ever had an allergic reaction to any other pain reliever or to a fever reducer  for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.  right before or after heart surgery  on more than 2 body areas at the same time  in the eyes, nose or mouth

📄 Ask a Doctor Before Use If 90 words ▾

Ask a doctor before use if  you have problems or serious side effects from taking pain relievers or fever reducers  stomach bleeding warning applies to you  you have a history of stomach problems, such as heartburn  you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke  you are taking a diuretic  you are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if  under a doctor’s care for any serious condition  taking any other drug

📄 When Using This Product 21 words ▾

When using this product  avoid contact with eyes, nose, or mouth  if eye contact occurs, rinse thoroughly with water

📄 Stop Use and Ask a Doctor If 109 words ▾

Stop use and ask a doctor if  pain gets worse or lasts more than 21 days  redness or swelling is present in the painful area  fever occurs  skin irritation occurs  any new symptoms appear. These could be signs of a serious condition.  you experience any of the following signs of stomach bleeding:  feel faint  have bloody or black stools  vomit blood  have stomach pain that does not get better  you have symptoms of heart problems or stroke:  chest pain  trouble breathing  leg swelling  weakness in one part of side of body  slurred speech

🤰 If Pregnant or Breast-Feeding 49 words ▾

Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 25 words ▾

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 6 words ▾

Questions or Comments? Call 1-800-826-8861 (www.salonpas.us)

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel 1 salonpas-ifc

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diclofenac Sodium (matched by generic name) — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diclofenac Sodium. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$30M
Claims incl. refills
804.1K
Beneficiaries
539.2K
Spend / beneficiary
$55.63
Spend / claim
$37.30
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 (this brand).

Top reported reactions

Pain7,443
Fatigue7,024
Rheumatoid Arthritis6,411
Rash6,130
Abdominal Discomfort6,034
Systemic Lupus Erythematosus5,897
Alopecia5,794

Age at onset

Neonate109
Infant6
Child12
Adolescent29
Adult3,858
Elderly1,379

Reporter sex

35,533 reports
Male · 26%
Female · 74%
Unknown · 0%

Serious outcomes

Hospitalization13,394
Disabling7,224
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 4,908 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

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 America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hisamitsu 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.
← 55328-0100-01 · Hisamitsu 55328-0900-02 · Hisamitsu →
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.