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Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride 250 mg; 5 mg; 2 mg; 10 mg Capsule, Liquid Filled, 12-count — NDC 63654-0800-12 package photo

Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride 250 mg; 5 mg; 2 mg; 10 mg Capsule, Liquid Filled, 12-count

by Selder, S.A. de C.V. · 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12)
NDC 63654-0800-12
🏷️ FDA NDC (as labeled) 63654-800-12 billing pads the product segment with a zero
This package
Contains12-count Pack sizes2 compare ↓
Also comes in: 6 capsules 63654-0800-06
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 63654-800-12
Product NDC 63654-800
11-digit billing NDC 63654080012
RxCUI 1193292
UNII 362O9ITL9D, 04JA59TNSJ, V1Q0O9OJ9Z, 9D2RTI9KYH
Application # M012
SPL Set ID da5b31dd-becd-471a-9392-d0ee4b8f9539
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Rece
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-11-15
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 63654-800-12 — 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 → 63654-0800-12. 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 marketedNov 2011
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

📖 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?

This is an oral capsule containing four active ingredients commonly used to manage symptoms of cough and cold. Acetaminophen is typically used to relieve pain and fever, while dextromethorphan functions as a cough suppressant. Chlorpheniramine maleate is an antihistamine commonly used to reduce sneezing, runny nose, and watery eyes. Phenylephrine hydrochloride is a nasal decongestant typically used to relieve nasal congestion. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this category.

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.

💊 What it looks like

Color blue
ShapeCapsule
ImprintXtra
Size1 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 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII U076Q6Q621
    Polyethylene glycol 1000 is a synthetic compound made from ethylene oxide. It serves as a solvent, lubricant, and humectant in medicines, helping dissolve active ingredients and improve how the product flows and feels.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesD&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 6 capsules
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
Sanaflu Xtra 10 mg/1; 5 mg/1; 250 mg/1; 2 mg 48201-0001-12 GRANDALL 12 capsules — — FDA listed —
Tabcin Extra Strength 250 mg/1; 5 mg/1; 2 mg/1; 10 mg 55758-0407-12 Pharmadel 12 capsules — — FDA listed —
Cough and Cold XL3 Xtra 250 mg/1; 5 mg/1; 2 mg/1; 10 mgthis 63654-0800-12 Selder, 12 capsules — — 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

🏛️
2011
On the market since
Nov 2011
📍
2026
Currently FDA-listed
15 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 Cough and Cold XL3 Xtra (this brand).

Top reported reactions

Asthenia1
Balance Disorder1
Bedridden1
Decreased Appetite1
Feeding Disorder1
Malaise1
Muscular Weakness1

Reporter sex

1 reports
Female · 100%
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
63654-0800-06 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06) 2018-10-15 Active
63654-0800-12 You're viewing this 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12) 2014-08-22 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63654-0800-12?
NDC 63654-0800-12 is a 12-count package — 12 capsule, liquid filled in 1 blister pack.
What is the difference between NDC 63654-0800-12 and NDC 63654-0800-06?
Both are Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride 250 mg; 5 mg; 2 mg; 10 mg Capsule, Liquid Filled — the drug itself is identical. NDC 63654-0800-12 is the 12-count package, while NDC 63654-0800-06 is the 6 capsules package.
What NDC number is used to bill for this package of Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride 250 mg; 5 mg; 2 mg; 10 mg Capsule, Liquid Filled?
Bill NDC 63654-0800-12 — the 11-digit billing format is 63654080012. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 63654-800-12, 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: 63654-0800-12, written without dashes as 63654080012. 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 63654-0800-12, the first segment (63654) is the labeler code FDA assigned to Selder, S.A. de C.V.; the middle segment (0800) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 6 capsules (63654-0800-06). 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?
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 63 words ▾

Uses temporarily relieves: • muscular aches and pains • headache • temporarily reduces fever • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • pressure • nasal congestion • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

⏱️ Dosage and Administration 92 words ▾

Directions • Do not use more than directed (see overdose warning) •do not take this product form more than 10 days unless directed by a doctor • Adults and children 12 years of age and over • take 2 capsule every 4 hours. • Do not take more than 12 capsules in 24 hours Children under 12 years of age • Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdoes) may cause liver damage. Do not exceed recommended dosage

⚠️ 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. Allergy 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 20 words ▾

Active ingredients (in each capsule) Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Antihistamine Antitussive Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63654-0605-20 · Selder, 63660-0002-01 · Huzhou →
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.