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Naproxen Sodium 220 mg Capsule, Liquid Filled, 5,000-count — NDC 53345-042-01 (Billing 53345-0042-01)

by Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd · 1 BAG in 1 BOX / 5000 CAPSULE, LIQUID FILLED in 1 BAG

This is a package of 5,000 capsules of Naproxen Sodium 220 mg Capsule, Liquid Filled from Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd, marketed since Mar 2018 and currently FDA-listed. It is this product's only package size.

NDC 53345-0042-01
🏷️ FDA NDC (as labeled) 53345-042-01 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 Naproxen Sodium (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0346-2025
Class II · Nov 7, 2023 — Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0124-2024
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) 53345-042-01
Product NDC 53345-042
11-digit billing NDC 53345004201
RxCUI 1112231
UNII 9TN87S3A3C
Application # ANDA208363
SPL Set ID 1d5981dd-e3f5-48a3-a5f1-ce49689cdfac
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-20
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance NAPROXEN SODIUM
Quick answers
  • RxCUI (RxNorm): 1112231
Why two NDCs? The FDA registers this code as 53345-042-01 — 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 → 53345-0042-01. 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) Propionic acid derivatives, Antiinflammatory products for vaginal administration, 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

📗 Our plain-language guide HelloPharmacist
  • It relieves pain, inflammation and fever. Prescription versions treat arthritis, tendonitis, bursitis, acute gout and painful periods. Over-the-counter versions handle minor aches...
  • Take it by mouth with a full glass of water. Over-the-counter products are taken every 8 to 12 hours while symptoms last, and you should use the smallest dose that works. For presc...
  • Headache, indigestion, heartburn, nausea and swelling are common. Call your doctor if you have black stools, vomit blood, a rash, yellow skin or eyes, or chest pain.
  • Usually not. Combining naproxen with other NSAIDs or aspirin raises bleeding risk with little added benefit. Naproxen can also interfere with low-dose aspirin taken for your heart,...
📖 Read our full Naproxen guide →
1
Nutrient depletion considerations

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

🧪 Full Naproxen 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 mLPer 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
53345-0042-01 You're viewing this Main listing 1 BAG in 1 BOX / 5000 CAPSULE, LIQUID FILLED in 1 BAG 2018-03-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naproxen Sodium 220 mg 46122-0780-64 AMERISOURCE 20 capsules $0.149 — Availability likely —
Naproxen Sodium 220 mg 70677-1148-01 Strategic 40 capsules $0.149 — Availability likely —
Naproxen Sodium 220 mg 62011-0369-01 Strategic 40 capsules $0.156 — Discontinued —
Aleve liquid gels 220 mg 00280-0105-02 Bayer 160 capsules — — FDA listed —
Aleve 220 mg 00280-6080-01 Bayer 120 capsules — — FDA listed —
Aleve Easy Open Arthritis Cap 220 mg 00280-6091-80 Bayer 80 capsules — — FDA listed —
Naproxen Sodium 220 mg 00363-0102-15 WALGREEN 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 00363-0177-11 WALGREEN 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 00363-0748-08 Walgreens 80 capsules — — FDA listed —
Naproxen Sodium 220 mg 11673-0651-78 TARGET 80 capsules — — FDA listed —
Naproxen Sodium 220 mg 11673-0748-18 TARGET 180 capsules — — FDA listed —
Naproxen Sodium 220 mg 11822-0788-04 Rite 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 21130-0748-20 Safeway, 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 21130-0948-11 Albertsons 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 30142-0285-22 KROGER 120 capsules — — FDA listed —
Naproxen Sodium 220 mg 36800-0204-11 TOP 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 37808-0049-15 HEB 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 41163-0079-15 SUPERVALU 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 41250-0225-15 MEIJER 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 41520-0748-20 Care 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 49035-0382-22 Wal-Mart 120 capsules — — FDA listed —
Naproxen Sodium 220 mg 49035-0748-12 EQUATE 120 capsules — — FDA listed —
Naproxen Sodium 220 mg 51013-0137-15 PuraCap 20 capsules — — FDA listed —
Naproxen Sodium 220 mgthis 53345-0042-01 Humanwell 5000 capsules — — FDA listed —
Naproxen Sodium 220 mg 53943-0179-11 DISCOUNT 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 55301-0748-20 AAFES/Your 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 55910-0748-20 Dolgencorp, 20 capsules — — FDA listed —
All Day Relief 220 mg 56062-0748-40 Publix 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 59428-0748-20 Productos 20 capsules — — Discontinued —
Naproxen Sodium 220 mg 59428-0784-20 Productos 20 capsules — — Discontinued —
Naproxen Sodium 220 mg 59726-0174-20 P 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 59726-0751-20 P 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 63868-0830-20 CHAIN 20 capsules — — FDA listed —
Naproxen Sodium 220 mg 63941-0681-16 VALU 50 capsules — — FDA listed —
Naproxen Sodium 220 mg 68016-0056-40 Premier 40 capsules — — FDA listed —
Naproxen Sodium 220 mg 69452-0179-22 Bionpharma 120 capsules — — FDA listed —
naproxen sodium 220 mg 69452-0259-22 Bionpharma 120 capsules — — Discontinued —
naproxen sodium 220 mg 69452-0284-25 Bionpharma 180 capsules — — FDA listed —
Naproxen Sodium 220 mg 69842-0748-08 CVS 80 capsules — — FDA listed —
Naproxen Sodium 220 mg 72288-0312-25 Amazon.com 180 capsules — — FDA listed —
Naproxen Sodium 220 mg 72476-0748-20 Care 20 capsules — — 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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

LabelerHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Application holderPURACAP PHARMACEUTICAL LLC
FDA applicationANDA208363 (ANDA)
Labeler code53345
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio4 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 26 words ▾

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

⏱️ Dosage and Administration 92 words ▾

Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period children under 12 years: ask a doctor

⚠️ Warnings 155 words ▾

Warnings Allergy alert Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.

The chance is 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 take more or for a longer time 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 30 words ▾

Other information each capsule contains: sodium 20 mg store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) read all directions and warnings before use. Keep carton.

🧪 Active Ingredient 16 words ▾

Active ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients FD&C blue#1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide, white ink

🎯 Purpose 8 words ▾

Purposes Pain reliever/fever reducer

Purposes Pain reliever/fever reducer

📄 Do Not Use 23 words ▾

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

📄 Ask a Doctor Before Use If 58 words ▾

Ask a doctor before use if the 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 have problems or serious side effects from taking pain relievers or fever reducers

📄 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 13 words ▾

When using this product take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 103 words ▾

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the capsule is stuck in your throat

🤰 If Pregnant or Breast-Feeding 48 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 7 words ▾

Questions or comments? Call toll free: 1-855-215-8180

📄 Package Label / Principal Display Panel 76 words ▾

PRINCIPAL DISPLAY PANEL - Shipping Label Naproxen Sodium 220 mg Bulk NDC: 53345-042-01 Each softgel contains: Naproxen Sodium 220 mg CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Quantity: 5,000 Capsules MADE IN CHINA IMPORTANT: 1.Inspect immediately upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light.

Do not refrigerate. 4.Store at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F). Shipping Label for Wuhan Shipping Label for PLD

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 Naproxen Sodium — the program that covers self-administered drugs. 4 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 Naproxen 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
$441.8K
Claims incl. refills
15.2K
Beneficiaries
11.4K
Spend / beneficiary
$38.70
Spend / claim
$29.13
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.

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 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 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.
← 53345-0039-02 · Humanwell 53345-0045-01 · Humanwell →
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.