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Quality Choice Severe Cold and Cough Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 650 mg; 25 mg; 10 mg Powder, For Solution, 6 packets — NDC 63868-0291-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Quality Choice Severe Cold and Cough Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 650 mg; 25 mg; 10 mg Powder, For Solution, 6 packets — NDC 63868-291-06 (Billing 63868-0291-06)

by Chain Drug Manufacturing Assn · 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET

This is a package of 6 packets of Quality Choice Severe Cold and Cough Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 650 mg; 25 mg; 10 mg Powder, For Solution from Chain Drug Manufacturing Assn, marketed since Jul 2018 and currently FDA-listed; retail pharmacies pay about $0.4817 per packet (NADAC). It is this product's only package size.

NDC 63868-0291-06
🏷️ FDA NDC (as labeled) 63868-291-06 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 63868-291-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63868 labeler · 291 product · 06 package
Package marketed since
Jul 16, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
6 EA per package
Barcode (UPC-A, from the NDC)
3 6386829106 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63868-291-06
Product NDC 63868-291
11-digit billing NDC 63868029106
NCPDP billing unit EA — each (per item)
RxCUI 1659960
UNII 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
Application # M012
SPL Set ID ce658dd5-b683-436e-b16b-0c06f6f87fd9
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 2018-07-16
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43994003903045
GPI class QC Severe Cold/Cough Nighttime
GCN Seq No 064453
GCN 14359
HICL code 035433
Ingredient (HICL) Diphenhyd/Phenyleph/Acetaminop
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3O
Therapeutic class — specific (HIC3) 1St Gen Antihistamine-Decongestant-Analgesic Comb
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name QC NIGHT SEVERE COLD-COUGH PKT
FDB brand name Nighttime Severe Cough-Cold
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 064453
  • GCN: 14359
  • GPI-14 (Medi-Span): 43994003903045
  • HICL (First Databank): 035433
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1659960
Why two NDCs? The FDA registers this code as 63868-291-06 — 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 → 63868-0291-06. 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

Label name QC NIGHT SEVERE COLD-COUGH PKT Ingredient Diphenhyd/Phenyleph/Acetaminop
🧪 What is this product?

Quality Choice Severe Cold and Cough Nighttime is an over-the-counter powder product that you mix with water and drink by mouth. It contains acetaminophen, which is typically used to reduce fever and relieve minor aches and pain. Diphenhydramine is an antihistamine commonly used to help relieve cold symptoms and promote drowsiness, while phenylephrine is a decongestant typically used to help clear nasal congestion. This combination product is intended for nighttime cold and cough 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.482 $2.89 / 6 powder
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.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2022 $0.482 $0.482
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
63868-0291-06 You're viewing this Main listing 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET 2018-07-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mgthis 63868-0291-06 Chain 6 packets $0.482 — FDA listed —
Theraflu Powerpods Nighttime Severe Cold 650 mg/1; 25 mg/1; 10 mg 00067-6095-01 Haleon 8 pouches — — FDA listed —
Theraflu Severe Cold Relief Nighttime 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-6803-02 Haleon 6 packets — — FDA listed —
Theraflu Nighttime Severe Cold And Cough 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-7918-06 Haleon 6 packets — — FDA listed —
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor 650 mg/1; 25 mg/1; 10 mg 00067-8212-01 Haleon 6 packets — — FDA listed —
Nighttime Wal Flu Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 00363-5410-06 WALGREEN 6 powders — — FDA listed —
up and up nighttime flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 11673-0113-07 Target 6 powders — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 41226-0541-06 KROGER 6 powders — — FDA listed —
Equate Flu and Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 49035-0964-91 Wal-Mart 6 powders — — FDA listed —
SanaTos Severe Cold Relief Nighttime 25 mg/1; 10 mg/1; 650 mg 55758-0385-06 Pharmadel 6 granules — — FDA listed —
dg health flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 55910-0964-91 Dolgencorp, 6 powders — — FDA listed —
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 10 mg/5g; 650 mg/5g; 25 mg/5g 58933-0551-01 Procter 5 g — — FDA listed —
Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mg 67091-0323-06 WinCo 6 packets — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 68163-0541-06 RARITAN 6 packets — — FDA listed —
Basic Care severe cold and cough 650 mg/1; 25 mg/1; 10 mg 72288-0964-91 Amazon.com 6 packets — — 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

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 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 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • 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 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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

The official label also statescitric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

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

LabelerChain Drug Manufacturing Assn
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Chain Drug Manufacturing Assn labeler code 63868

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 47 words ▾

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

⏱️ Dosage and Administration 99 words ▾

Directions do not use more than directed take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose children under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

⚠️ Warnings 97 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 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.

📦 Storage and Handling 18 words ▾

Other information each packet contains: potassium 6 mg store at room temperature. Protect from excessive heat and moisture.

🧪 Active Ingredient 16 words ▾

Active ingredients (in each packet) Acetaminophen, 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

🎯 Purpose 12 words ▾

Purposes Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant

📄 Do Not Use 106 words ▾

Do not use in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist. with any other product containing diphenhydramine, even one used on the skin 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 a MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 59 words ▾

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, asthma or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

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

📄 When Using This Product 39 words ▾

When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

📄 Stop Use and Ask a Doctor If 69 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 12 words ▾

If pregnant or breast- feeding, ask a health care professional before use.

📄 Keep Out of Reach of Children 45 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. 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 4 words ▾

Questions or comments? 1-866-467-2748

📄 Package Label / Principal Display Panel 11 words ▾

Principal Display Quality Choice Severe Cold and Cough Nighttime 6 Packets

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63868-0287-25 · Chain 63868-0292-08 · QUALITY →
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.