Home › NDC Lookup › Ingredients › Acetaminophen, Guaifenesin, And Phenylep... › 63868-0103-24
Head Congestion Mucus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 200 mg; 5 mg Tablet, Coated — NDC 63868-0103-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Head Congestion Mucus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 200 mg; 5 mg Tablet, Coated — NDC 63868-103-24 (Billing 63868-0103-24)

by CHAIN DRUG MARKETING ASSOCIATION INC · 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK

This is a package of Head Congestion Mucus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 200 mg; 5 mg Tablet, Coated from CHAIN DRUG MARKETING ASSOCIATION INC, marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.

NDC 63868-0103-24
🏷️ FDA NDC (as labeled) 63868-103-24 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

NDC database record

One package, one record: these facts belong to NDC 63868-103-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63868 labeler · 103 product · 24 package
Package marketed since
Aug 3, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0635515987395
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63868-103-24
Product NDC 63868-103
11-digit billing NDC 63868010324
RxCUI 1243679
UNII 362O9ITL9D, 495W7451VQ, 04JA59TNSJ
UPC 0635515987395
Application # M012
SPL Set ID 0955d856-cc4e-4ef2-8bc0-1a632a5b5f79
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-03
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 52200020000510
GPI class QC Gas Relief
Quick answers
  • GPI-14 (Medi-Span): 52200020000510
  • RxCUI (RxNorm): 1243679
Why two NDCs? The FDA registers this code as 63868-103-24 — 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 → 63868-0103-24. 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?

This is an oral coated tablet sold as an over-the-counter cold and congestion product under FDA's OTC monograph rules. It contains acetaminophen, typically used as a pain reliever and fever reducer; guaifenesin, an expectorant commonly used to help thin and clear mucus; and phenylephrine hydrochloride, a nasal decongestant typically used to relieve stuffiness. The combination addresses multiple cold symptoms in a single dose.

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
63868-0103-24 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK 2022-08-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 46122-0412-62 AmeriSource 12 tablets $0.111 — Availability likely —
Cold Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 46122-0415-62 AmeriSource 12 tablets $0.111 — Availability likely —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 46122-0712-60 AMERISOURCE 10 tablets $0.111 — Availability likely —
Sinus Relief Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 70000-0080-01 CARDINAL 10 tablets $0.111 — Availability likely —
Head Congestion and Mucus 325 mg/1; 200 mg/1; 5 mg 70000-0083-01 Cardinal 12 tablets $0.111 — Availability likely —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 70677-1005-01 STRATEGIC 12 tablets $0.111 — Availability likely —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 70677-1259-01 Strategic 12 tablets $0.111 — Availability likely —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83324-0107-20 CHAIN 10 tablets $0.111 — Availability likely —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 83324-0112-24 CHAIN 12 tablets $0.111 — Availability likely —
Cold plus Flu Congestion Severe 325 mg/1; 200 mg/1; 5 mg 83324-0114-24 CHAIN 12 tablets $0.111 — Availability likely —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 83324-0115-24 CHAIN 12 tablets $0.111 — Availability likely —
Mucinex Sinus-Max Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 63824-0201-44 Reckitt 2 tablets $0.529 — FDA listed —
Severe Sinus Daytime, Non-Drowsy 325 mg/1; 200 mg/1; 5 mg 00363-5027-07 Walgreen 12 tablets — — Discontinued —
Sinus Pressure and Pain 325 mg/1; 200 mg/1; 5 mg 00363-6028-09 Walgreen 10 tablets — — FDA listed —
Severe Sinus Congestion 325 mg/1; 200 mg/1; 5 mg 00363-6150-09 Walgreen 10 tablets — — FDA listed —
Sinus Congestion and Pain Relief Non-Drowsy/Daytime 325 mg/1; 200 mg/1; 5 mg 11822-0527-08 Rite 12 tablets — — FDA listed —
severe sinus congestion relief Maximum Strength 325 mg/1; 200 mg/1; 5 mg 11822-5160-09 Rite 10 tablets — — FDA listed —
Severe Sinus Congestion and Pain Maximum Strength 325 mg/1; 200 mg/1; 5 mg 21130-0615-09 Better 10 tablets — — FDA listed —
Sinus PE Head Congestion and Mucus 325 mg/1; 200 mg/1; 5 mg 21130-0627-08 Better 12 tablets — — FDA listed —
Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 30142-0727-08 Kroger 12 tablets — — FDA listed —
Daytime Sinus Severe 325 mg/1; 200 mg/1; 5 mg 30142-0732-08 Kroger 12 tablets — — FDA listed —
Sinus Relief Pressure and Pain 325 mg/1; 200 mg/1; 5 mg 30142-0828-09 Kroger 10 tablets — — FDA listed —
Sinus Congestion and Pain Severe 200 mg/1; 5 mg/1; 325 mg 36800-0505-05 TopCare 12 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 36800-0575-02 TopCo 12 tablets — — FDA listed —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 36800-0793-02 TOPCARE 12 tablets — — FDA listed —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 37808-0273-02 HEB 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 37808-0367-02 HEB 10 tablets — — FDA listed —
Cold Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 37808-0775-02 HEB 12 tablets — — FDA listed —
Head Congestion Plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 41163-0712-02 United 12 tablets — — FDA listed —
sinus severe 325 mg/1; 200 mg/1; 5 mg 41250-0219-05 Meijer 12 tablets — — Discontinued —
mucus relief sinus severe congestion and pain 325 mg/1; 200 mg/1; 5 mg 41250-0267-02 Meijer 10 tablets — — Discontinued —
Cold Relief Severe Head Congestion 325 mg/1; 200 mg/1; 5 mg 41250-0275-02 Meijer 12 tablets — — Discontinued —
head congestion plus mucus PE 325 mg/1; 200 mg/1; 5 mg 41250-0573-02 MEIJER 12 tablets — — Discontinued —
Head Congestion plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 42507-0173-02 HYVEE 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 42507-0219-05 HYVEE 12 tablets — — FDA listed —
Cold plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 42507-0375-02 HYVEE 12 tablets — — FDA listed —
Xpect Cold Relief 200 mg/1; 325 mg/1; 5 mg 42961-0112-11 Cintas 160 tablets — — Discontinued —
Severe Congestion Relief Maximum Strength Sinus 325 mg/1; 200 mg/1; 5 mg 49035-0165-09 Wal-Mart 10 tablets — — FDA listed —
Sinus Congestion and Pain Severe 325 mg/1; 200 mg/1; 5 mg 49035-0527-08 Wal-Mart 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50269-0507-25 JC 2 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50269-0551-01 JC 2 tablets — — FDA listed —
SUDAFED PE Head Congestion Plus Mucus 325 mg/1; 200 mg/1; 5 mg 50580-0447-01 Kenvue 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50580-0507-01 Kenvue 12 tablets — — FDA listed —
Tylenol Cold Plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 50580-0566-25 Kenvue 12 tablets — — FDA listed —
Head Congestion Mucus PE 325 mg/1; 200 mg/1; 5 mg 50804-0173-02 GOODSENSE 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50804-0672-05 GoodSense 12 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 50804-0805-03 GoodSense 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 50844-0572-02 L.N.K. 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 51316-0516-09 CVS 10 tablets — — FDA listed —
Severe Sinus Pain and Congestion 325 mg/1; 200 mg/1; 5 mg 51316-0927-08 CVS 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 53209-1004-02 Morning 2 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 53943-0167-02 DISCOUNT 10 tablets — — FDA listed —
Cold Plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 53943-0175-02 DISCOUNT 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 53943-0319-05 DISCOUNT 12 tablets — — FDA listed —
Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 55319-0815-19 Family 8 tablets — — FDA listed —
Sinus Severe Daytime 325 mg/1; 200 mg/1; 5 mg 55910-0529-08 DOLGENCORP, 12 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 55910-0927-08 DOLGENCORP, 12 tablets — — FDA listed —
Severe Sinus Pain and Congestion Daytime 325 mg/1; 200 mg/1; 5 mg 59779-0275-08 CVS 12 tablets — — FDA listed —
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 63824-0241-10 Reckitt 10 tablets — — FDA listed —
Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength 325 mg/1; 200 mg/1; 5 mg 63824-0243-20 Reckitt 10 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 63868-0071-24 Chain 12 tablets — — FDA listed —
Severe Cold Head Congestion 325 mg/1; 200 mg/1; 5 mg 63868-0081-24 Chain 12 tablets — — Discontinued —
Head Congestion Mucus PE 325 mg/1; 200 mg/1; 5 mgthis 63868-0103-24 CHAIN 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 63868-0722-20 Chain 10 tablets — — FDA listed —
Pressure Pain Mucus PE 325 mg/1; 200 mg/1; 5 mg 63868-0747-24 Chain 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 63941-0167-02 VALU 10 tablets — — FDA listed —
Pressure and Pain Plus Mucus PE 325 mg/1; 200 mg/1; 5 mg 63941-0173-02 VALU 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 63941-0275-08 Valu 12 tablets — — FDA listed —
Non-Drowsy Sinus Severe, Circle K 325 mg/1; 200 mg/1; 5 mg 66715-5544-09 Lil' 2 tablets — — FDA listed —
Non-Drowsy Sinus Severe, Circle K 200 mg/1; 5 mg/1; 325 mg 66715-5632-03 Lil' 2 tablets — — FDA listed —
Sinus Relief, Caseys 4good 325 mg/1; 200 mg/1; 5 mg 66715-6332-03 Lil' 6 tablets — — FDA listed —
Tylenol Sinus Severe, Lil Drug Store 325 mg/1; 200 mg/1; 5 mg 66715-6457-07 Lil 2 tablets — — FDA listed —
Tylenol Sinus Severe, CVP HEALTH 325 mg/1; 200 mg/1; 5 mg 66715-6557-02 Lil 2 tablets — — FDA listed —
Daytime Sinus Severe 200 mg/1; 5 mg/1; 325 mg 66715-6744-09 Lil' 2 tablets — — FDA listed —
Tylenol Sinus Severe, TRAVEL BASIX 325 mg/1; 200 mg/1; 5 mg 66715-7857-02 Lil 2 tablets — — FDA listed —
Lil Drug Store Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 66715-9757-02 Lil 2 tablets — — FDA listed —
Cold and Head Congestion Relief Severe 325 mg/1; 200 mg/1; 5 mg 67091-0212-24 WinCo 12 tablets — — FDA listed —
Nasal Decongestant PE and Pain Relief Plus Mucus Relief 325 mg/1; 200 mg/1; 5 mg 67091-0349-24 Winco 12 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 67414-0507-00 Jones 2 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 67751-0239-01 Navajo 2 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 68016-0504-24 CHAIN 12 tablets — — Discontinued —
Mucus Relief Sinus Severe Congestion Relief 325 mg/1; 200 mg/1; 5 mg 68016-0549-20 CHAIN 10 tablets — — Discontinued —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 68016-0717-24 CHAIN 12 tablets — — Discontinued —
Severe Cold Head Congestion 325 mg/1; 200 mg/1; 5 mg 68998-0175-02 Marc 12 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 68998-0219-05 MARC 12 tablets — — FDA listed —
Cold plus Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 68998-0275-02 MARC 12 tablets — — FDA listed —
Congestion and Headache 325 mg/1; 200 mg/1; 5 mg 69842-0651-01 CVS 10 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 69842-0786-02 CVS 10 tablets — — Discontinued —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 70264-0026-02 R 2 tablets — — FDA listed —
Sinus Severe 325 mg/1; 200 mg/1; 5 mg 72036-0119-05 Harris 12 tablets — — FDA listed —
Mucus Relief Sinus Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 72036-0167-02 HARRIS 10 tablets — — FDA listed —
Cold Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 72036-0175-02 Harris 12 tablets — — FDA listed —
Sinus Sevre 325 mg/1; 200 mg/1; 5 mg 72476-0119-05 RETAIL 12 tablets — — FDA listed —
Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 72476-0167-02 Retail 10 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 73097-0014-02 Savings 2 tablets — — FDA listed —
Cold and Head Congestion Severe 325 mg/1; 200 mg/1; 5 mg 79481-3572-08 Meijer 12 tablets — — FDA listed —
Pressure, Pain and Mucus 325 mg/1; 200 mg/1; 5 mg 79481-5072-08 Meijer 12 tablets — — FDA listed —
Severe Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 79481-5196-09 Meijer 10 tablets — — FDA listed —
Sinus Severe Non Drowsy, Daytime 325 mg/1; 200 mg/1; 5 mg 79481-7250-08 Meijer 12 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0029-01 Shield 12 tablets — — Discontinued —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0057-01 Shield 12 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0107-01 Shield 12 tablets — — FDA listed —
Severe Sinus Congestion and Pain 325 mg/1; 200 mg/1; 5 mg 83059-0121-06 Shield 60 tablets — — FDA listed —
Tylenol Sinus Severe 325 mg/1; 200 mg/1; 5 mg 85237-1955-01 Select 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

🏛️
2022
On the market since
Aug 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
ShapeOval
ImprintAAA;1173
Size19 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 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 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

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

The official label also statescolloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, 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

LabelerCHAIN DRUG MARKETING ASSOCIATION INC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedAug 2022
Product typeHuman Otc Drug
Portfolio70 products on file

More NDCs from CHAIN DRUG MARKETING ASSOCIATION INC 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 53 words ▾

Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever

⏱️ Dosage and Administration 41 words ▾

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 18 words ▾

Other information store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information and warnings

🧪 Active Ingredient 22 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

🎯 Purpose 22 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

📄 Do Not Use 95 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 48 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

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

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 50 words ▾

PRINCIPAL DISPLAY PANEL Quality Choice® NDC 63868-103-24 †Compare to Active Ingredients in SUDAFED PE® Head Congestion + Mucus Head Congestion + Mucus PE Acetaminophen, Guaifenesin, Phenylephrine HCl Pain Reliever | Fever Reducer, Expectorant, Nasal Decongestant For Relief of: Sinus Pressure Headache Chest Congestion Non-Drowsy Actual Size 24 CAPLETS image description

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 CHAIN DRUG MARKETING ASSOCIATION INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CHAIN DRUG MARKETING ASSOCIATION 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.
← 63868-0102-24 · CHAIN 63868-0108-01 · 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.