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Quality Choice Effervescent Cold Relief - Orange Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate 7.8 mg; 325 mg; 2 mg Tablet, Effervescent — NDC 63868-0568-20 package photo

Quality Choice Effervescent Cold Relief - Orange Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate 7.8 mg; 325 mg; 2 mg Tablet, Effervescent

by Chain Drug Marketing Association · 10 POUCH in 1 CARTON (63868-568-20) / 2 TABLET, EFFERVESCENT in 1 POUCH
NDC 63868-0568-20
🏷️ FDA NDC (as labeled) 63868-568-20 billing pads the product segment with a zero
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) 63868-568-20
Product NDC 63868-568
11-digit billing NDC 63868056820
NCPDP billing unit EA — each (per item)
RxCUI 1536840
UNII 27O3Q5ML57, R16CO5Y76E, V1Q0O9OJ9Z
UPC 0635515997899
Application # M012
SPL Set ID 9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-15
Route ORAL
Dosage form TABLET, EFFERVESCENT
Substance PHENYLEPHRINE BITARTRATE; ASPIRIN; CHLORPHENIRAMINE MALEATE
GCN Seq No 065743
GCN 27781
HICL code 036694
Ingredient (HICL) Chlorphenir/Phenyleph/Aspirin
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 B5N
Therapeutic class — specific (HIC3) 1St Gen Antihist-Decon-Analgesic, Salicylate
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name QC COLD RELIEF PLUS EFF TABLET
FDB brand name Cold Relief Plus
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 63868-568-20 — 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 → 63868-0568-20. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and 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.

🏭 Manufacturer & labeler

LabelerChain Drug Marketing Association
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio128 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name QC COLD RELIEF PLUS EFF TABLET Ingredient Chlorphenir/Phenyleph/Aspirin
🧪 What is this product?

Quality Choice Effervescent Cold Relief - Orange is an over-the-counter effervescent tablet taken by mouth that combines three active ingredients to address common cold symptoms. Aspirin is a nonsteroidal anti-inflammatory drug typically used to reduce pain and fever. Chlorpheniramine maleate is an antihistamine commonly used to relieve allergy and cold-related symptoms such as sneezing and runny nose. Phenylephrine bitartrate is a decongestant typically used to help shrink nasal passages and ease congestion.

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 orange
ShapeRound
ImprintCF
Size25 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 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.

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

The official label also statesacesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

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
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest 7 mg/1; 2 mg/1; 325 mg 00280-0020-01 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz 325 mg/1; 2 mg/1; 7.8 mg 00280-0060-01 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Medicine Sparkling Original 325 mg/1; 2 mg/1; 7.8 mg 00280-1400-32 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Orange Zest 325 mg/1; 2 mg/1; 7.8 mg 00280-1510-20 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Sparkling Original 325 mg/1; 7.8 mg/1; 2 mg 00280-1520-04 Bayer 2 tablets — — FDA listed —
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve 325 mg/1; 2 mg/1; 7.8 mg 00280-8270-16 Bayer 2 tablets — — FDA listed —
Walgreens Effervescent Cold Relief Plus 325 mg/1; 2 mg/1; 7.8 mg 00363-0875-36 Walgreens 2 tablets — — FDA listed —
Kroger Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 30142-0875-36 Kroger 2 tablets — — FDA listed —
Effervescent Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 36800-0768-20 Topco 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 37808-0768-20 H. 2 tablets — — FDA listed —
Equaline Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 41163-0768-20 United 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 41250-0123-20 Meijer 2 tablets — — FDA listed —
Meijer Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 41250-0768-36 Meijer 2 tablets — — FDA listed —
Equate Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 49035-0768-67 Walmart 2 tablets — — FDA listed —
Top Value Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 50201-7682-02 Tower 2 tablets — — FDA listed —
Top Value Effervescent Cold Relief - Orange 7.8 mg/1; 325 mg/1; 2 mg 50201-8752-00 Tower 2 tablets — — FDA listed —
Good Sense Effervescent Cold Relief 2 mg/1; 325 mg/1; 7.8 mg 50804-0873-20 Good 2 tablets — — FDA listed —
Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 53943-0873-20 Discount 2 tablets — — FDA listed —
Family Wellness Effervescent Cold Relief Orange 2 mg/1; 325 mg/1; 7.8 mg 55319-0875-20 Family 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 55910-0769-20 DOLGENCORP, 2 tablets — — FDA listed —
Dollar General Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 55910-0873-20 DOLGENCORP, 2 tablets — — FDA listed —
Quality Choice Effervescent Cold Relief Plus 325 mg/1; 2 mg/1; 7.8 mg 63868-0228-20 Chain 2 tablets — — FDA listed —
Quality Choice Effervescent Cold Relief - Orange 7.8 mg/1; 325 mg/1; 2 mgthis 63868-0568-20 Chain 2 tablets — — FDA listed —
Best Choice Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 63941-0873-20 Valu 2 tablets — — FDA listed —
WinCo Foods Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 67091-0109-20 WinCo 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 69842-0875-20 CVS 2 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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 Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate — the ingredient across all brands.

Top reported reactions

Cerebrovascular Accident9
Drug Dependence5
Malaise5
Rectal Haemorrhage5
Choking4
Dizziness4
Nausea4

Age at onset

Adolescent1
Adult14
Elderly8

Reporter sex

72 reports
Male · 33%
Female · 64%
Unknown · 3%

Serious outcomes

Death13
Hospitalization6
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 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
63868-0568-20 You're viewing this 10 POUCH in 1 CARTON (63868-568-20) / 2 TABLET, EFFERVESCENT in 1 POUCH 2020-06-15 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 63868-568-20, 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: 63868-0568-20, written without dashes as 63868056820. 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 63868-0568-20, the first segment (63868) is the labeler code FDA assigned to Chain Drug Marketing Association; the middle segment (0568) 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 Chain Drug Marketing Association. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chain Drug Marketing Association 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 38 words ▾

Uses ■ temporarily relieves these symptoms due to the common cold: ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure ■ temporarily reduces fever

⏱️ Dosage and Administration 51 words ▾

Directions ■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor

⚠️ Warnings 184 words ▾

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock 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 longer time than directed Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 21 words ▾

Active ingredients (in each effervescent tablet) Aspirin 325 mg (NSAID)* Chlorpheniramine maleate 2 mg Phenylephrine Bitartrate 7.8 mg *Nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

🎯 Purpose 19 words ▾

Purpose Aspirin 325 mg (NSAID)*..............................Pain reliever/fever reducer Chlorpheniramine maleate 2 mg...................Antihistamine Phenylephrine Bitartrate 7.8 mg...................Nasal decongestant *Nonsteroidal anti-inflammatory drug

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63868-0567-20 · CHAIN 63868-0569-24 · Chain →
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.