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Equaline congestion relief Ibuprofen, phenylephrine HCl 200 mg; 10 mg Tablet, Film Coated — NDC 41163-0158-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Equaline congestion relief Ibuprofen, phenylephrine HCl 200 mg; 10 mg Tablet, Film Coated — NDC 41163-158-60 (Billing 41163-0158-60)

by United Natural Foods, Inc. dba UNFI · 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Equaline congestion relief Ibuprofen, phenylephrine HCl 200 mg; 10 mg Tablet, Film Coated from United Natural Foods, Inc. dba UNFI, marketed since Jul 2015 and currently FDA-listed.

NDC 41163-0158-60
🏷️ FDA NDC (as labeled) 41163-158-60 billing pads the product segment with a zero
This package
Contains1 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Product page 41163-0158-46 Also comes in: 1 tablet 41163-158-46
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

NDC database record

One package, one record: these facts belong to NDC 41163-158-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
41163 labeler · 158 product · 60 package
Package marketed since
Mar 8, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4116315860 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41163-158-60
Product NDC 41163-158
11-digit billing NDC 41163015860
RxCUI 1369775
UNII WK2XYI10QM, 04JA59TNSJ
Application # ANDA203200
SPL Set ID 06dcece5-0fdc-4ff1-a8b1-fadb503a9f50
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43991002400320
GPI class EQL Congestion Relief
GCN Seq No 072215
GCN 36337
HICL code 036618
Ingredient (HICL) Ibuprofen/Phenylephrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B5
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.2)
HIC3 code B5G
Therapeutic class — specific (HIC3) Decongestant-Nsaid, Cox Non-Spec Comb.
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name EQL CONGEST RLF 200-10 MG TAB
FDB brand name Congestion Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 072215
  • GCN: 36337
  • GPI-14 (Medi-Span): 43991002400320
  • HICL (First Databank): 036618
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1369775
Why two NDCs? The FDA registers this code as 41163-158-60 — 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 → 41163-0158-60. 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 cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
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 EQL CONGEST RLF 200-10 MG TAB Ingredient Ibuprofen/Phenylephrine Hcl
📖 What it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It gives short-term relief of cold and flu symptoms. That includes headache, fever, sinus pressure, nasal congestion and minor aches and pains. It also reduces nasal swelling so yo...
  • Adults and children 12 and older take 1 tablet about every 4 hours while symptoms last. Don’t go over 6 in 24 hours unless your doctor says so. If it upsets your stomach, take it w...
  • Some people feel nervous, dizzy or have trouble sleeping, and stomach upset can happen. Stop the medicine and call your doctor if these show up. Get help right away for black or bl...
  • Not always, so check with me first. Don’t use it with a prescription MAOI or within 2 weeks of stopping one. Blood thinners, steroids and other NSAIDs raise stomach bleeding risk,...
📖 Read our full Ibuprofen / Phenylephrine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 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.
Try another pack size: 1 tablet
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
41163-0158-46 41163-158-46 Main listing 10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK 2015-07-17 — Discontinued by firm
41163-0158-60 You're viewing this 20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK 2021-03-08 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 20 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Equaline congestion relief Ibuprofen, phenylephrine HCl 200 mg; 10 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Advil Sinus Congestion And Pain 200 mg/1; 10 mg 00573-0199-01 Haleon 1 tablet — — FDA listed —
Congestion Relief 200 mg/1; 10 mg 37808-0158-60 H 1 tablet — — Discontinued —
Equaline congestion relief 200 mg/1; 10 mgthis 41163-0158-60 United 1 tablet — — FDA listed —
Congestion Relief 200 mg/1; 10 mg 41250-0158-60 Meijer 1 tablet — — FDA listed —
Sudafed PE Head Congestion Plus Pain 200 mg/1; 10 mg 50580-0436-01 Kenvue 10 tablets — — FDA listed —
Advil Sinus Congestion and Pain Relief 200 mg/1; 10 mg 67751-0150-01 Navajo 1 tablet — — 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 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.

What it looks like

Color Brown
ShapeOval
ImprintL158
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.

🧪 Avoiding an ingredient? See Ibuprofen / Phenylephrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesacesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, 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.

Manufacturer & labeler

LabelerUnited Natural Foods, Inc. dba UNFI
Application holderPERRIGO R AND D CO
FDA applicationANDA203200 (ANDA)
Labeler code41163
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio211 products on file

More NDCs from United Natural Foods, Inc. dba UNFI labeler code 41163

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 44 words ▾

Uses • temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 67 words ▾

Directions • do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist. • do not use more than 6 tablets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age

⚠️ Warnings ~3 min read ▾

Warnings Allergy alert: Ibuprofen 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.

Do not use • in children under 12 years of age because this product contains too much medication for children under this age • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke • you are taking a diuretic Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other product that contains phenylephrine or any other nasal decongestant • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs 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 7 days • fever gets worse or lasts more than 3 days • nasal congestion lasts for more than 7 days • symptoms continue or get worse • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use ibuprofen 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📦 Storage and Handling 23 words ▾

Other information • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). • read all warnings and directions before use. Keep carton.

🧪 Active Ingredient 16 words ▾

Active ingredients (in each tablet) Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

🎯 Purpose 6 words ▾

Purposes Pain reliever/fever reducer Nasal decongestant

📄 Do Not Use 98 words ▾

Do not use • in children under 12 years of age because this product contains too much medication for children under this age • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

📄 Ask a Doctor Before Use If 74 words ▾

Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke • you are taking a diuretic

📄 Ask a Doctor or Pharmacist Before Use If 53 words ▾

Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other product that contains phenylephrine or any other nasal decongestant • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug

📄 When Using This Product 14 words ▾

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

📄 Stop Use and Ask a Doctor If 126 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 7 days • fever gets worse or lasts more than 3 days • nasal congestion lasts for more than 7 days • symptoms continue or get worse • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • any new symptoms appear

🤰 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 ibuprofen 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 22 words ▾

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

📄 Questions or Comments 4 words ▾

Questions or comments? 1-855-423-2630

📄 Package Label / Principal Display Panel 57 words ▾

Principal Display Panel EQUALINE ® compare to Advil ® Sinus Congestion & Pain active ingredients congestion relief ibuprofen 200 mg pain reliever/fever reducer (NSAID) phenylephrine hydrochloride 10 mg nasal decongestant tablets sinus congestion & pain Nasal Congestion Headache Sinus Pressure Fever Nasal Swelling Body Aches NON-DROWSY actual size 20 coated tablets ONE TABLET DOSE congestion relief image

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

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 Equaline congestion relief (this brand).

Top reported reactions

Covid-191
Disease Recurrence1
Inflammation1
Peripheral Swelling1
Rheumatoid Arthritis1
Weight Increased1

Reporter sex

3 reports
Male · 67%
Female · 33%
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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 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 United Natural Foods, Inc. dba UNFI. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tablet (41163-0158-46). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
United Natural Foods, Inc. dba UNFI 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.
← 41163-0157-12 · United 41163-0166-26 · United →
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.