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Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride 325 mg; 2 mg; 5 mg Tablet, 20-count — NDC 63654-0605-20 package photo

Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride 325 mg; 2 mg; 5 mg Tablet, 20-count

by Selder, S.A. de C.V. · 2 BLISTER PACK in 1 BOX (63654-605-20) / 10 TABLET in 1 BLISTER PACK
NDC 63654-0605-20
🏷️ FDA NDC (as labeled) 63654-605-20 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 63654-605-20
Product NDC 63654-605
11-digit billing NDC 63654060520
RxCUI 1046781
UNII 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
UPC 0645981000214
Application # M012
SPL Set ID e2c35fae-9dd6-51f2-e053-2995a90a1e9e
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
Why two NDCs? The FDA registers this code as 63654-605-20 — 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 → 63654-0605-20. 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.

🏭 Manufacturer & labeler

LabelerSelder, S.A. de C.V.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63654
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio8 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

🧪 What is this product?

Cold Medicine XL3 is an over-the-counter oral tablet made under FDA's monograph rules for cold and flu remedies. It combines three active ingredients: acetaminophen, commonly used to reduce fever and relieve pain; chlorpheniramine maleate, an antihistamine typically used to reduce allergy symptoms and sneezing; and phenylephrine hydrochloride, a decongestant commonly used to relieve nasal congestion. This combination product is designed for typical cold and flu symptom relief.

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.

🧪 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.

💲 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
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 46122-0660-62 AMERISOURCE 12 tablets $0.088 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70000-0211-01 Cardinal 12 tablets $0.088 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70677-1004-01 STRATEGIC 12 tablets $0.088 — Availability likely —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 83324-0086-24 CHAIN 12 tablets $0.088 — 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 mgthis 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 mg 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.

🔬 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 Cold Medicine XL3 (this brand).

Top reported reactions

Drug Screen Positive4
Malaise4
Anxiety3
Fatigue3
Nasal Congestion3
Nasopharyngitis3
Nausea3

Reporter sex

43 reports
Male · 55%
Female · 45%

Serious outcomes

Hospitalization15
Life-threatening4
Disabling3
Death2
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63654-0605-20 You're viewing this 2 BLISTER PACK in 1 BOX (63654-605-20) / 10 TABLET in 1 BLISTER PACK 2022-06-27 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

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 FDA registers it as 63654-605-20, 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: 63654-0605-20, written without dashes as 63654060520. 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 63654-0605-20, the first segment (63654) is the labeler code FDA assigned to Selder, S.A. de C.V.; the middle segment (0605) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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: this package is listed as actively marketed, with no marketing end date reported by Selder, S.A. de C.V.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Selder, S.A. de C.V. 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 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63654-0601-10 · Selder, 63654-0800-06 · Selder, →
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.