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Diclofenac Sodium 10 mg/g Gel — NDC 58602-0609-07 package photo

Diclofenac Sodium 10 mg/g Gel

by Aurohealth LLC · 1 TUBE in 1 CARTON (58602-609-07) / 100 g in 1 TUBE
NDC 58602-0609-07
🏷️ FDA NDC (as labeled) 58602-609-07 billing pads the product segment with a zero
OTC Generic 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 →

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

FDA NDC (as labeled) 58602-609-07
Product NDC 58602-609
11-digit billing NDC 58602060907
RxCUI 855633
UNII QTG126297Q
Application # ANDA204306
SPL Set ID 2a599579-b2b0-4423-8e30-fe04bf815870
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 2023-08-11
Route TOPICAL
Dosage form GEL
Substance DICLOFENAC SODIUM
Why two NDCs? The FDA registers this code as 58602-609-07 — 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 → 58602-0609-07. 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.

🏭 Manufacturer & labeler

LabelerAurohealth LLC
Application holderAUROLIFE PHARMA LLC
FDA applicationANDA204306 (ANDA)
Labeler code58602
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio174 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 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
  • An actinic keratosis — often just called an AK — is a rough, scaly patch on the skin caused by years of sun exposure. These patches are considered precancerous, meaning they could...
  • What exactly is an actinic keratosis, and why do I need a prescription gel for it?
  • The typical treatment course runs 60 to 90 days of twice-daily application — that's a solid commitment, but it's necessary for the gel to do its job. Here's the thing: even after y...
  • How long do I need to use this gel, and how will I know it's working?
📖 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.

💊 What it looks like

Color White
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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statescarbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/58039/2020

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense arthritis pain 10 mg/g 00113-1189-01 L. 1 tube $0.083 — Availability likely —
Good Sense Arthritis Pain 10 mg/g 00113-8175-01 L. 1 tube $0.083 — Availability likely —
Diclofenac Sodium 10 mg/g 45802-0953-01 Padagis 1 tube $0.083 — Availability likely —
Diclofenac Sodium 10 mg/g 68001-0621-45 BluePoint 1 tube $0.083 — Availability likely —
Diclofenac sodium 10 mg/g 69097-0720-44 Cipla 1 tube $0.083 — Availability likely —
Diclofenac sodium 10 mg/g 69238-2053-01 Amneal 1 tube $0.083 — Availability likely —
Diclofenac Sodium 10 mg/g 70512-0106-10 SOLA 1 tube $0.083 — Availability likely —
Arthritis Pain 10 mg/g 70677-1125-01 Strategic 1 tube $0.083 — Availability likely —
Foster And Thrive Arthritis Pain 10 mg/g 70677-1293-01 Strategic 1 tube $0.083 — Availability likely —
Diclofenac Sodium 10 mg/g 76282-0103-39 EXELAN 1 tube $0.083 — Availability likely —
Arthritis Pain Reliever 10 mg/g 83324-0306-01 QUALITY 1 tube $0.083 — Availability likely —
Arthritis Pain Reliever 10 mg/g 46122-0752-37 AmerisourceBergen 1 tube $0.123 — Availability likely —
Diclofenac sodium 10 mg/g 70000-0555-01 CARDINAL 1 tube $0.123 — 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/g 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/gthis 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 — — FDA listed —
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 —
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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.

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

Medicare Part D (outpatient prescription) spending for Diclofenac Sodium — 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. 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 Diclofenac Sodium — the ingredient across all brands.

Top reported reactions

Pain15,671
Fatigue13,844
Arthralgia11,333
Rash10,855
Rheumatoid Arthritis10,744
Abdominal Discomfort9,636
Nausea9,507

Age at onset

Neonate343
Infant33
Child52
Adolescent148
Adult10,813
Elderly5,384

Reporter sex

155,962 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Life-threatening12,256
Disabling11,529
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 20,254 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58602-0609-07 You're viewing this 1 TUBE in 1 CARTON (58602-609-07) / 100 g in 1 TUBE 2023-08-11 Active

🧭 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

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 58602-609-07, 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: 58602-0609-07, written without dashes as 58602060907. 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 58602-0609-07, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0609) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aurohealth LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 53 words ▾

Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, 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 185 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 areas at 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 area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your diclofenac sodium topical gel arthritis pain.

The dosing card is re-usable.

⚠️ Warnings 184 words ▾

Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially 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 day 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.

📦 Storage and Handling 32 words ▾

Other information store at 20° to 25°C (68° to 77°F). Keep from freezing. read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.

🧪 Active Ingredient 16 words ▾

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

🧪 Inactive Ingredients 45 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 Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/58039/2020

🎯 Purpose 4 words ▾

Purpose Arthritis pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58602-0608-01 · Aurohealth 58602-0610-05 · Aurohealth →
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.