Diclofenac Sodium 10 mg/g Gel — NDC 68001-0621-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Diclofenac Sodium 10 mg/g Gel — NDC 68001-621-45 (Billing 68001-0621-45)

by BluePoint Laboratories · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Diclofenac Sodium 10 mg/g Gel from BluePoint Laboratories, marketed since May 2025 and currently FDA-listed; retail pharmacies pay about $0.0813 per g (NADAC). It is this product's only package size.

NDC 68001-0621-45
🏷️ FDA NDC (as labeled) 68001-621-45 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68001-621-45
Product NDC 68001-621
11-digit billing NDC 68001062145
NCPDP billing unit GM — per gram (weight)
RxCUI 855633
UNII QTG126297Q
Application # ANDA210986
SPL Set ID 274543d2-a9a6-1e37-e063-6394a90ae3f1
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 2025-05-17
Route TOPICAL
Dosage form GEL
Substance DICLOFENAC SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90210030304020
GCN Seq No 018293
GCN 45680
HICL code 003733
Ingredient (HICL) Diclofenac Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5E
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory, Nsaids
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name DICLOFENAC SODIUM 1% GEL
FDB brand name Diclofenac Sodium
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 018293
  • GCN: 45680
  • GPI-14 (Medi-Span): 90210030304020
  • HICL (First Databank): 003733
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 855633
Why two NDCs? The FDA registers this code as 68001-621-45 — 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 → 68001-0621-45. 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

Label name DICLOFENAC SODIUM 1% GEL Ingredient Diclofenac Sodium
📖 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 →
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 $0.081 $8.13 / 100 g
Medicaid paysCMS SDUD · 12 mo $0.1531 $15.31 / 100 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.095 $0.081
▼ Down 15% over the last 10 months.
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
68001-0621-45 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2025-05-17 — 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/gthis 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 +44%
Diclofenac sodium 10 mg/g 70000-0555-01 CARDINAL 1 tube $0.117 — Availability likely +44%
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/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 — — 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 —
Diclofenac Sodium 10 mg/g 68071-3483-01 NuCare 1 tube — — FDA listed —
Dolo-NeuroBion Arthritis Pain 10 mg/g 55959-0123-50 BENARD 1 tube — — FDA listed —
Diclofenac Sodium 10 mg/g 71085-0084-03 IPG 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

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

💡 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 statesInactive ingredients: carbomer homopolymer Type C, coco-caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBluePoint Laboratories
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA210986 (ANDA)
Labeler code68001
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio347 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 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 183 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, 1%.

The dosing card is re-usable.

⚠️ Warnings 191 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 non-prescription 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 59 words ▾

Other information Store at 20-25 o C (68°F - 77°F). Keep from freezing. Read all product information before using. Keep the dosing card, the carton and accompanying User Guide for important information. Inactive ingredients Carbomer homopolymer Type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution. Question and comments 1-888-375-3784

🧪 Active Ingredient 13 words ▾

Active ingredient Diclofenac Sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti‑inflammatory drug

🧪 Inactive Ingredients 24 words ▾

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

🎯 Purpose 4 words ▾

Purpose Arthritis Pain Reliever

📄 Do Not Use 63 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 80 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 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 22 words ▾

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

📄 When Using This Product 19 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 93 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 or side of body slurred speech

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in 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 20 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Package Label / Principal Display Panel 126 words ▾

PRINCIPAL DISPLAY PANEL Carton Label - NDC 68001-621-45 Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever For external use only For daily Treatment of Arthritis Pain Anti-Inflammatory Net Wt 3.53 oz (100g) Rev: 10/24 Container Label - NDC 68001-621-45 Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever For external use only For Daily Treatment of Arthritis Pain, Anti-Inflammatory Net Wt 3.53 oz (100g) Rev: 10/24 Dosing Card Use Enclosed Dosing Card to Measure a Dose How to Use •For arthritis pain only •Use 4 times a day •May take up to 7 days to work for your arthritis pain •for use on no more than 2 body areas •Use up to 21 days unless directed by your doctor Carton Label Container Label Dosing Card

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
83.2K
Units reimbursed last 4 qtrs
10.3M
Gross reimbursed last 4 qtrs
$1.57M
Avg / prescription
$18.86
Avg / unit
$0.1531
Latest quarter Q1 2026
20.4KRx
Medicaid pays / g
$0.1531
gross reimbursed
vs
NADAC / g
$0.0813
acquisition cost
=
Spread
+$0.0718
+88% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
62% FFS 38% MCO
Fee-for-service · 51,331 Rx Managed care · 31,891 Rx
State Medicaid map
Alaska: 3,200 units · 437 per 100k residents AK Maine: 130,600 units · 9,362 per 100k residents ME Washington: no data reported WA Idaho: 33,600 units · 1,711 per 100k residents ID Montana: 10,100 units · 892 per 100k residents MT North Dakota: no data reported ND Minnesota: 232,402 units · 4,051 per 100k residents MN Wisconsin: 101,950 units · 1,725 per 100k residents WI Michigan: 277,780 units · 2,768 per 100k residents MI New York: 1,330,700 units · 6,799 per 100k residents NY Vermont: no data reported VT New Hampshire: 7,700 units · 549 per 100k residents NH Oregon: 184,920 units · 4,369 per 100k residents OR Nevada: 127,200 units · 3,982 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 1,575 units · 23.0 per 100k residents IN Ohio: 598,600 units · 5,079 per 100k residents OH Pennsylvania: 1,574,696 units · 12,149 per 100k residents PA New Jersey: 273,450 units · 2,943 per 100k residents NJ Massachusetts: 111,301 units · 1,590 per 100k residents MA California: 3,416,452 units · 8,768 per 100k residents CA Utah: 16,800 units · 492 per 100k residents UT Colorado: 106,600 units · 1,814 per 100k residents CO Nebraska: 113,000 units · 5,713 per 100k residents NE Missouri: 271,800 units · 4,387 per 100k residents MO Kentucky: 689,907 units · 15,243 per 100k residents KY West Virginia: no data reported WV Virginia: 202,550 units · 2,324 per 100k residents VA Maryland: 27,400 units · 443 per 100k residents MD Connecticut: 155,300 units · 4,294 per 100k residents CT Rhode Island: 12,200 units · 1,114 per 100k residents RI Arizona: 46,200 units · 622 per 100k residents AZ New Mexico: 46,800 units · 2,214 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 266 units · 3.7 per 100k residents TN North Carolina: no data reported NC South Carolina: 46,800 units · 871 per 100k residents SC Delaware: 34,700 units · 3,366 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 7,900 units · 71.6 per 100k residents GA D.C.: 13,100 units · 1,929 per 100k residents DC Hawaii: 35,700 units · 2,488 per 100k residents HI Texas: no data reported TX Florida: 10,400 units · 46.0 per 100k residents FL
Units reimbursed · per 100k residents
3.715,243
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 15,243 /100k
2 Pennsylvania 12,149 /100k
3 Maine 9,362 /100k
4 California 8,768 /100k
5 New York 6,799 /100k
6 Nebraska 5,713 /100k
7 Ohio 5,079 /100k
8 Missouri 4,387 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
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.