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Mucus Relief Cold Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 10 mg; 200 mg; 5 mg Tablet, Coated — NDC 83324-0104-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mucus Relief Cold Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 10 mg; 200 mg; 5 mg Tablet, Coated — NDC 83324-104-20 (Billing 83324-0104-20)

by CHAIN DRUG MARKETING ASSOCIATION, INC. · 2 PACKAGE in 1 CARTON / 10 TABLET, COATED in 1 PACKAGE

This is a package of Mucus Relief Cold Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 10 mg; 200 mg; 5 mg Tablet, Coated from CHAIN DRUG MARKETING ASSOCIATION, INC., marketed since Aug 2024 and currently FDA-listed; retail pharmacies pay about $0.1321 per unit (NADAC). It is this product's only package size.

NDC 83324-0104-20
🏷️ FDA NDC (as labeled) 83324-104-20 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 Oct 1, 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 83324-104-20 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83324 labeler · 104 product · 20 package
Package marketed since
Aug 7, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8332410420 4
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83324-104-20
Product NDC 83324-104
11-digit billing NDC 83324010420
NCPDP billing unit EA — each (per item)
RxCUI 1110988
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID 32d1ce6e-2617-4b50-a9e6-2e1941465dff
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 2024-08-07
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

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

GPI-14 43998304100320
GCN Seq No 060553
GCN 26742
HICL code 035445
Ingredient (HICL) Phenylephrine/Dm/Acetaminop/Gg
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4P
Therapeutic class — specific (HIC3) Non-Opioid Antituss-Decongestant-Analgesic-Expect
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name QC MUCUS RLF COLD-FLU-THRT CPT
FDB brand name Mucus Rlf Cold-Flu-Sore Throat
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 060553
  • GCN: 26742
  • GPI-14 (Medi-Span): 43998304100320
  • HICL (First Databank): 035445
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1110988
Why two NDCs? The FDA registers this code as 83324-104-20 — 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 → 83324-0104-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name QC MUCUS RLF COLD-FLU-THRT CPT Ingredient Phenylephrine/Dm/Acetaminop/Gg
🧪 What is this product?

This is an over-the-counter coated tablet taken by mouth that combines four active ingredients commonly used to manage cold and flu symptoms. Acetaminophen is typically used to reduce fever and relieve pain and aches. Dextromethorphan is a cough suppressant found in many cold products. Guaifenesin functions as an expectorant, meant to help thin mucus. Phenylephrine is a decongestant commonly included to help relieve nasal 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.

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 $0.132 $2.64 / 20 tablets
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
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.143 $0.127
▲ Up 4% over the last 10 months.
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
83324-0104-20 You're viewing this Main listing 2 PACKAGE in 1 CARTON / 10 TABLET, COATED in 1 PACKAGE 2024-08-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 46122-0418-62 AmeriSource 12 tablets $0.132 — Availability likely —
Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 70000-0525-01 Cardinal 12 tablets $0.132 — Availability likely —
Leader Daytime Severe Cold and Flu Relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 70000-0636-01 Cardinal 2 tablets $0.132 — Availability likely —
foster and thrive daytime severe cold and flu relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 70677-1027-01 Strategic 2 tablets $0.132 — Availability likely —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mgthis 83324-0104-20 CHAIN 10 tablets $0.132 — Availability likely —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0105-20 CHAIN 10 tablets $0.132 — Availability likely —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0106-20 CHAIN 10 tablets $0.132 — Availability likely —
Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0111-24 CHAIN 12 tablets $0.132 — Availability likely —
Mucinex Fast-Max Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0237-20 Reckitt 10 tablets $0.603 — FDA listed +357%
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0242-20 Reckitt 10 tablets $0.603 — FDA listed +357%
Maximum Strength Mucinex Fast-Max Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0575-04 Reckitt 2 tablets $0.603 — FDA listed +357%
Theraflu ExpressMax Severe Cold and Flu Caplets 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 00067-8145-01 Haleon 10 tablets — — FDA listed —
good sense severe day time cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 00113-4500-53 L. 2 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 00363-0640-08 Walgreen 12 tablets — — FDA listed —
Sinus Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 00363-6171-09 Walgreen 10 tablets — — FDA listed —
Day Cold And Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11673-0347-02 TARGET 10 tablets — — FDA listed —
sinus pressure and pain and cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11673-0961-09 Target 10 tablets — — FDA listed —
Cold and Flu Relief Severe Daytime 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11822-0640-08 Rite 12 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11822-5031-08 Rite 12 tablets — — FDA listed —
Cold and Flu maximum strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11822-6179-09 Rite 10 tablets — — Discontinued —
Mucus Relief Cold and Flu All In One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0298-04 TOPCARE 10 tablets — — FDA listed —
Cold And Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0502-05 TOPCARE 12 tablets — — FDA listed —
topcare day time cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0581-62 Topco 2 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0697-04 TOPCO 10 tablets — — FDA listed —
DayQuil Severe plus Vicks VapoCool Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37000-0524-02 The 2 tablets — — FDA listed —
Daytime Severe Cold And Flu Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0178-03 HEB 12 tablets — — FDA listed —
Mucus Relief Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0497-04 HEB 10 tablets — — FDA listed —
Mucus Relief Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0598-04 HEB 10 tablets — — FDA listed —
Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0663-05 HEB 12 tablets — — FDA listed —
Severe Cold 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41163-0053-08 United 12 tablets — — FDA listed —
daytime severe cold multi-symptom 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41163-0503-08 United 12 tablets — — FDA listed —
Daytime Cold and Flu 10 mg/1; 200 mg/1; 5 mg/1; 325 mg 41226-0675-24 KROGER 12 tablets — — Discontinued —
mucus relief cold flu and sore throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0197-04 Meijer 10 tablets — — Discontinued —
Cold and Flu Daytime Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0643-08 Meijer 12 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0663-05 Meijer 12 tablets — — Discontinued —
mucus relief sinus pressure, pain and cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0979-02 Meijer 10 tablets — — Discontinued —
mucus relief all in one cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0981-04 Meijer 10 tablets — — Discontinued —
Cold plus Flu Severe 5 mg/1; 325 mg/1; 10 mg/1; 200 mg 42507-0163-05 HYVEE 12 tablets — — FDA listed —
Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 42507-0278-03 HYVEE 12 tablets — — FDA listed —
Cold and Flu severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 49035-0053-08 Wal-Mart 12 tablets — — FDA listed —
equate vapor ice cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 49035-0813-62 Wal-Mart 2 tablets — — FDA listed —
Tylenol Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 50269-0402-25 JC 2 tablets — — FDA listed —
Tylenol Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 50269-0550-01 JC 2 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 50580-0402-01 Kenvue 2 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 50804-0503-08 Geiss, 12 tablets — — FDA listed —
Cold and Flu Daytime Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 50844-0640-21 L.N.K. 8 tablets — — FDA listed —
Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 51316-0530-08 CVS 12 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 51316-0627-09 CVS 10 tablets — — FDA listed —
daytime severe cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 51316-0731-62 CVS 2 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53209-1003-02 Morning 2 tablets — — FDA listed —
COLD and FLU SEVERE 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0163-05 DISCOUNT 12 tablets — — FDA listed —
Daytime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0178-03 DISCOUNT 12 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0197-04 DISCOUNT 10 tablets — — FDA listed —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0198-04 DISCOUNT 10 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0199-02 DISCOUNT 10 tablets — — FDA listed —
dg health day time severe cold and flu relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 55910-0432-53 Dolgencorp, 2 tablets — — FDA listed —
Sinus Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 55910-0613-09 DOLGENCORP, 10 tablets — — FDA listed —
DoloMax Cold Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 55959-0133-01 BENARD 12 tablets — — FDA listed —
Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 56062-0197-04 PUBLIX 10 tablets — — FDA listed —
Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 56062-0198-04 PUBLIX 10 tablets — — FDA listed —
sinus pressure pain and cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 56062-0399-02 PUBLIX 10 tablets — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride 200 mg/1; 5 mg/1; 325 mg/1; 10 mg 57344-0163-05 AAA 12 tablets — — FDA listed —
Mucinex Fast-Max Cold and Flu 325 mg/1; 200 mg/1; 5 mg/1; 10 mg 63824-0514-01 Reckitt 10 tablets — — FDA listed —
Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0003-24 Chain 12 tablets — — Discontinued —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0587-20 CHAIN 10 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0588-20 CHAIN 10 tablets — — FDA listed —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0589-20 CHAIN 10 tablets — — FDA listed —
Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0263-05 VALU 12 tablets — — FDA listed —
Sinus Relief Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0399-02 VALU 10 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0497-04 VALU 10 tablets — — FDA listed —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0498-04 VALU 10 tablets — — FDA listed —
Cold Multi-Symptom Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0509-08 Valu 12 tablets — — FDA listed —
Daytime Cold and Flu Severe, Caseys 4goog 5 mg/1; 10 mg/1; 200 mg/1; 325 mg 66715-6304-03 Lil' 6 tablets — — FDA listed —
Daytime Cold and Flu Severe, Caseys 4good 5 mg/1; 10 mg/1; 200 mg/1; 325 mg 66715-6315-08 Lil' 8 tablets — — FDA listed —
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6404-02 Lil' 2 tablets — — FDA listed —
Tylenol Cold plus Flu Severe, Lil Drug Store 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6456-07 Lil 2 tablets — — FDA listed —
DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6504-03 Lil' 6 tablets — — FDA listed —
Cold and Flu Daytime Severe, 24/7 Life 5 mg/1; 10 mg/1; 200 mg/1; 325 mg 66715-6515-08 Lil' 8 tablets — — FDA listed —
Tylenol Cold plus Flu Severe, CVP HEALTH 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6556-02 Lil 2 tablets — — FDA listed —
DayQuil Severe plus VapoCOOL Cold and Flu, CVP HEALTH 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6580-02 Lil' 2 tablets — — FDA listed —
Tylenol Cold plus Flu Severe, TRAVEL BASIX 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-7856-02 Lil 2 tablets — — FDA listed —
Lil Drug Store Tylenol Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-9756-02 Lil 2 tablets — — FDA listed —
DayQuil Severe Plus VapoCOOL Cold And Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-9904-02 Lil' 2 tablets — — FDA listed —
Cold and Flu Relief Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 67091-0288-24 WinCo 12 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 67091-0299-02 WINCO 10 tablets — — FDA listed —
Tylenol Cold Plus Flu Severe Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 67414-0402-00 Jones 2 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 67751-0240-01 Navajo 2 tablets — — FDA listed —
Mucus Relief Cold and Flu all in one 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 68016-0625-20 CHAIN 10 tablets — — Discontinued —
Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 68998-0263-05 MARC 12 tablets — — FDA listed —
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69423-0987-02 The 2 tablets — — FDA listed —
Head and Cold 325 mg/1; 5 mg/1; 10 mg/1; 200 mg 69732-0003-01 Hi-Tech 30 tablets — — FDA listed —
Severe Cold and Flu Relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0503-08 CVS 12 tablets — — FDA listed —
cooling severe daytime 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0723-62 CVS 2 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0796-02 CVS 10 tablets — — Discontinued —
Tylenol Cold And Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 70264-0025-02 R 2 tablets — — FDA listed —
Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0155-05 Harris 12 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0199-02 HARRIS 10 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0297-04 HARRIS 10 tablets — — FDA listed —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0298-04 HARRIS 10 tablets — — FDA listed —
basic care daytime severe cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72288-0357-62 Amazon.com 2 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72476-0163-05 RETAIL 12 tablets — — FDA listed —
Cold Flu And Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72476-0197-04 RETAIL 10 tablets — — FDA listed —
Tylenol Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 73097-0011-02 Savings 2 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79481-5030-08 Meijer 12 tablets — — FDA listed —
Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79481-6170-09 Meijer 10 tablets — — FDA listed —
Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79481-6171-09 Meijer 10 tablets — — FDA listed —
Sinus Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79481-6172-09 Meijer 10 tablets — — FDA listed —
Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79903-0218-20 WALMART 10 tablets — — FDA listed —
foster and thrive daytime severe cold and flu relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 85766-0179-12 Sportpharm 2 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 85237-1956-01 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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 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 red
ShapeOval
ImprintAAA;1165
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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 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.

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

The official label also statescolloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, 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 code83324
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio122 products on file

More NDCs from CHAIN DRUG MARKETING ASSOCIATION, INC. labeler code 83324

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 🆘 Overdosage 📦 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 43 words ▾

Uses temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 46 words ▾

Directions do not take more than directed (see Overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years of age and older: take 2 caplets every 4 hours children under 12 years of age: do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. 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. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease 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 use more than directed 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 Taking more than the recommended dose (overdose) may cause liver damage.

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.

🆘 Overdosage 51 words ▾

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. 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 10 words ▾

Other information store between 20-25°C (68-77°F) in a dry place

🧪 Active Ingredient 28 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

🧪 Inactive Ingredients 37 words ▾

Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

🎯 Purpose 28 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

📄 Do Not Use 79 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.

📄 Ask a Doctor Before Use If 48 words ▾

Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease 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 10 words ▾

When using this product do not use more than directed

📄 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 68 words ▾

PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NSC 83324-104-20 †Compare to Active Ingredients in MUCINEX® FAST-MAX® Cold, Flu & Sore Throat Mucus Relief Cold, Flu & Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Pain Reliever | Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant For Relief of: Headache, Fever & Sore Throat Cough Nasal & Chest Congestion Thins & Loosens Mucus For Ages 12+ Actual Size 20 CAPLETS image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Covid-19131
Disease Recurrence107
Nausea83
Nasopharyngitis78
Diarrhoea65
Dizziness64
Fatigue62

Age at onset

Child4
Adolescent5
Adult122
Elderly44

Reporter sex

935 reports
Male · 32%
Female · 68%

Serious outcomes

Hospitalization124
Life-threatening15
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 144 35
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.
← 83324-0103-10 · CHAIN 83324-0105-20 · 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.