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Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride 325 mg; 2 mg; 5 mg Tablet, 20-count — NDC 76095-0011-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride 325 mg; 2 mg; 5 mg Tablet, 20-count — NDC 76095-011-20 (Billing 76095-0011-20)

by Midway Importing, Inc. · 2 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK

This is a package of 20 tablets of Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride 325 mg; 2 mg; 5 mg Tablet from Midway Importing, Inc., marketed since Jun 2022 and currently FDA-listed. It is this product's only package size.

NDC 76095-0011-20
🏷️ FDA NDC (as labeled) 76095-011-20 billing pads the product segment with a zero
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76095-011-20
Product NDC 76095-011
11-digit billing NDC 76095001120
RxCUI 1046781
UNII 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
UPC 0645981000214
Application # M012
SPL Set ID e41b9beb-e274-5c02-e053-2995a90ad0f8
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-27
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1046781
Why two NDCs? The FDA registers this code as 76095-011-20 — 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 → 76095-0011-20. 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 Anilides class.

Drug family (ATC) Anilides
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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

Cold Medicine XL3 is an oral tablet sold over the counter under FDA's OTC monograph rules for cold and flu products. It combines acetaminophen, a pain reliever and fever reducer; chlorpheniramine maleate, an antihistamine typically used to ease sneezing and itching; and phenylephrine hydrochloride, a decongestant commonly used to relieve nasal congestion. This combination is intended for people seeking symptom relief during cold and allergy seasons.

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.
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
76095-0011-20 You're viewing this Main listing 2 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK 2022-06-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 46122-0660-62 AMERISOURCE 12 tablets $0.086 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70000-0211-01 Cardinal 12 tablets $0.086 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70677-1004-01 STRATEGIC 12 tablets $0.086 — Availability likely —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 83324-0086-24 CHAIN 12 tablets $0.086 — Availability likely —
FLONASE Headache and Allergy Relief 325 mg/1; 2 mg/1; 5 mg 00135-0578-01 Haleon 12 tablets — — FDA listed —
Multi-Symptom Allergy 325 mg/1; 2 mg/1; 5 mg 00363-0559-08 Walgreen 12 tablets — — FDA listed —
PhysiciansCare Allergy Multi-Symptom Relief 325 mg/1; 2 mg/1; 5 mg 00924-0091-01 Acme 2 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 36800-0628-02 TOPCO 12 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 37808-0628-02 HEB 12 tablets — — FDA listed —
Medique Medicidin D 325 mg/1; 2 mg/1; 5 mg 47682-0120-13 Unifirst 2 tablets — — FDA listed —
Otis Clapp Valihist 325 mg/1; 2 mg/1; 5 mg 47682-0543-03 Unifirst 2 tablets — — FDA listed —
Relief-PE 325 mg/1; 5 mg/1; 2 mg 50332-0153-04 HART 100 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 50804-0128-02 GOODSENSE 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 50844-0455-08 L.N.K. 12 tablets — — FDA listed —
Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0005-01 FORTUNE 24 tablets — — FDA listed —
Extra Fast Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0010-01 FORTUNE 24 tablets — — FDA listed —
Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0011-01 FORTUNE 24 tablets — — FDA listed —
Extra Fast Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0014-01 FORTUNE 24 tablets — — FDA listed —
Defensol D 325 mg/1; 2 mg/1; 5 mg 53145-0005-02 Menper 100 tablets — — FDA listed —
Allergy Multisymptom 325 mg/1; 2 mg/1; 5 mg 53943-0228-02 DISCOUNT 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 55301-0455-08 ARMY 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 55910-0455-08 DOLGENCORP, 12 tablets — — FDA listed —
Allergy Multi Symptom 5 mg/1; 325 mg/1; 2 mg 57344-0928-02 AAA 12 tablets — — FDA listed —
Cold Medicine 325 mg/1; 2 mg/1; 5 mg 63654-0275-20 Selder, 20 tablets — — FDA listed —
Cold Medicine XL3 325 mg/1; 2 mg/1; 5 mg 63654-0605-20 Selder, 20 tablets — — FDA listed —
Allergy Multisymptom 325 mg/1; 2 mg/1; 5 mg 63868-0578-24 CHAIN 12 tablets — — FDA listed —
Allergy Sinus, Lil Drug Store 325 mg/1; 5 mg/1; 2 mg 66715-9927-03 Lil' 6 tablets — — FDA listed —
Allergy Multi Symptom 2 mg/1; 5 mg/1; 325 mg 68998-0228-02 MARC 12 tablets — — FDA listed —
Cold Medicine 325 mg/1; 2 mg/1; 5 mg 69168-0004-51 Allegiant 20 tablets — — FDA listed —
Allergy MultiSymptom 325 mg/1; 2 mg/1; 5 mg 72476-0128-02 RETAIL 12 tablets — — FDA listed —
Cold Medicine XL3 325 mg/1; 2 mg/1; 5 mgthis 76095-0011-20 Midway 20 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 white
ShapeRound
ImprintXL3
Size11 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 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 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 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.
  • 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.

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

The official label also statesalcohol, croscarmellose sodium, hypromellose, lactose monhydrate (derived from milk), magnesium stearate, polyethylene glycol, purified water, 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

LabelerMidway Importing, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code76095
First marketedJun 2022
Product typeHuman Otc Drug
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 🧪 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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing

⏱️ Dosage and Administration 65 words ▾

Directions ■ Do not use more than directed ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.

⚠️ Warnings 78 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 12 tablets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product Alergy alert acetaminophen may cause severe skin reactions. Symptoms may include ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away

🧪 Active Ingredient 16 words ▾

Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylepherine HCl 5 mg

🧪 Inactive Ingredients 20 words ▾

Inactive Ingredients alcohol, croscarmellose sodium, hypromellose, lactose monhydrate (derived from milk), magnesium stearate, polyethylene glycol, purified water, talc, titanium dioxide

🎯 Purpose 7 words ▾

Purposes Pain reliever/fever reducer Antihistamine Nasal decongestant

📄 Do Not Use 96 words ▾

Do not use ■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ if you are taking a 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. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

📄 Ask a Doctor Before Use If 42 words ▾

Ask adoctor before use if you have ■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

Ask a doctor or pharmacist before use if you ■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers

📄 When Using This Product 45 words ▾

When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 49 words ▾

Stop use and ask a doctor if ■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days

📄 Keep Out of Reach of Children 60 words ▾

Keep out of reach of children If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 9 words ▾

Questions and Comments? 1-855-259-1590 Monday through Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 4 words ▾

Package Label package label

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

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Midway Importing, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Midway Importing, Inc. 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.
← 76095-0010-10 · MIDWAY 76095-0012-20 · Midway →
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.