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Naproxen Sodium PM 220 mg; 25 mg Tablet, 20-count — NDC 70677-0064-01 package photo

Naproxen Sodium PM 220 mg; 25 mg Tablet, 20-count

by Strategic Sourcing Services LLC · 1 BOTTLE, PLASTIC in 1 BOX (70677-0064-1) / 20 TABLET in 1 BOTTLE, PLASTIC
NDC 70677-0064-01
🏷️ FDA NDC (as labeled) 70677-0064-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Aug 27, 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

FDA NDC (as labeled) 70677-0064-1
Product NDC 70677-0064
11-digit billing NDC 70677006401
NCPDP billing unit EA — each (per item)
RxCUI 1550957
UNII 9TN87S3A3C, TC2D6JAD40
UPC 0010939921444
Application # ANDA209726
SPL Set ID 03a331d8-c957-4949-894f-51d9bd15e0d0
Established class (EPC) Anti-Inflammatory Agents; Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors; Histamine H1 Receptor Antagonists
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-31
Marketing end 2026-12-31
Route ORAL
Dosage form TABLET
Substance NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
GCN Seq No 073286
GCN 37667
HICL code 041669
Ingredient (HICL) Naproxen Sod/Diphenhydramine
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2S
Therapeutic class — specific (HIC3) Analgesic,Nsaid-1St Gen.antihistamine,Sedative Cmb
AHFS code 04:04.04.00
AHFS class Ethanolamine Derivatives
FDB label name SM NAPROXEN PM 220-25 MG CPLT
FDB brand name Naproxen Pm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-0064-1 — a 5-4-1 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 package segment → 70677-0064-01. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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

LabelerStrategic Sourcing Services LLC
Application holderAMNEAL PHARMACEUTICALS CO GMBH
FDA applicationANDA209726 (ANDA)
Labeler code70677
First marketedDec 2018
Product typeHuman Otc Drug
Portfolio316 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

Label name SM NAPROXEN PM 220-25 MG CPLT Ingredient Naproxen Sod/Diphenhydramine
📗 Our plain-language guide HelloPharmacist
  • They're very similar — naproxen sodium is just the salt form of naproxen, and it dissolves in water more quickly. That means your body absorbs naproxen sodium a bit faster, so it t...
  • What's the difference between naproxen and naproxen sodium — are they the same thing?
  • You can take it either way, but taking it with food, milk, or a full glass of water is a good idea because it helps protect your stomach. Naproxen can irritate the lining of your s...
  • Can I take naproxen on an empty stomach, or do I need to eat first?
📖 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.

💊 What it looks like

Color blue
ShapeCapsule
ImprintAC37
Size15 mm
ScoringNot scored
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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statescarnauba wax, FD&C blue #2, aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

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 eachPer 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 naproxen sodium 25 mg/1; 220 mg 00113-8264-58 L. 40 tablets — — Discontinued —
Aleve PM 25 mg/1; 220 mg 00280-1200-01 Bayer 120 tablets — — FDA listed —
All Night Pain Relief Pm 25 mg/1; 220 mg 00363-2264-27 Walgreen 80 tablets — — FDA listed —
up and up naproxen sodium pm 25 mg/1; 220 mg 11673-0687-27 Target 80 tablets — — FDA listed —
Naproxen Sodium and Diphenhydramine HCL 25 mg/1; 220 mg 11673-0819-08 TARGET 80 tablets — — FDA listed —
Naproxen Sodium Pm 25 mg/1; 220 mg 21130-0639-71 Safeway 50 tablets — — FDA listed —
Naproxen Sodium Diphenhydramine Hydrochloride 220 mg/1; 25 mg 21130-0814-05 SAFEWAY 50 tablets — — FDA listed —
naproxen sodium pm 25 mg/1; 220 mg 30142-0383-60 Kroger 20 tablets — — Discontinued —
naproxen sodium pm 25 mg/1; 220 mg 30142-0753-27 Kroger 80 tablets — — FDA listed —
topcare all night pain relief pm 25 mg/1; 220 mg 36800-0264-27 Topco 80 tablets — — FDA listed —
naproxen sodium pm 25 mg/1; 220 mg 37808-0264-27 H 80 tablets — — FDA listed —
equaline naproxen sodium pm 25 mg/1; 220 mg 41163-0593-58 United 40 tablets — — Discontinued —
naproxen sodium pm 25 mg/1; 220 mg 41250-0526-27 Meijer 80 tablets — — FDA listed —
careone naproxen sodium pm 25 mg/1; 220 mg 41520-0264-27 American 80 tablets — — FDA listed —
dg health naproxen sodium pm 25 mg/1; 220 mg 55910-0858-27 Dolgencorp 80 tablets — — FDA listed —
Naproxen Sodium PM 220 mg/1; 25 mg 62011-0396-01 Strategic 20 tablets — — Discontinued —
Naproxen Sodium and Diphenhydramine HCl 220 mg/1; 25 mg 62207-0814-38 Granules 37500 tablets — — FDA listed —
Naproxen Sodium and Diphenhydramine HCl 220 mg/1; 25 mg 69238-1422-02 Amneal 20 tablets — — FDA listed —
Naproxen Sodium Diphenhydramine HCl 220 mg/1; 25 mg 69842-0328-02 CVS 20 tablets — — FDA listed —
Naproxen Sodium PM 220 mg/1; 25 mgthis 70677-0064-01 Strategic 20 tablets — — FDA listed —
basic care naproxen sodium pm 25 mg/1; 220 mg 72288-0310-06 Amazon.com 160 tablets — — FDA listed —
Naproxen Sodium Diphenhydramine HCL 25 mg/1; 220 mg 79903-0204-20 Walmart 20 tablets — — 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
Dec 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.

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

Medicare Part D (outpatient prescription) spending for Naproxen Sodium (matched by generic name) — 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. CMS lists 4 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
$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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70677-0064-01 You're viewing this 1 BOTTLE, PLASTIC in 1 BOX (70677-0064-1) / 20 TABLET in 1 BOTTLE, PLASTIC 2018-12-31 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 70677-0064-1, 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: 70677-0064-01, written without dashes as 70677006401. 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 70677-0064-01, the first segment (70677) is the labeler code FDA assigned to Strategic Sourcing Services LLC; the middle segment (0064) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 it is currently marketed — but Strategic Sourcing Services LLC has reported a marketing end date of 2026-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Strategic Sourcing Services 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

Uses for relief of occasional sleeplessness when associated with minor aches and pains help you fall asleep and stay asleep

⏱️ Dosage and Administration 49 words ▾

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets at bedtime do not take more than 2 tablets in 24 hours if taken with food, this product may take longer to work

⚠️ Warnings 154 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) 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

🧪 Active Ingredient 20 words ▾

Active ingredient (in each caplet) Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients carnauba wax, FD&C blue #2, aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

🎯 Purpose 5 words ▾

Purpose Nighttime sleep-aid Pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70677-0057-01 · Strategic 70677-0078-01 · Strategic →
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.