Home › NDC Lookup › Ingredients › Acetaminophen, Dextromethorphan Hydrobro... › 56062-0198-04
⚪image loading
(from DailyMed)

Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 10 mg; 200 mg; 5 mg Tablet, Coated

by PUBLIX SUPER MARKETS INC · 2 BLISTER PACK in 1 CARTON (56062-198-04) / 10 TABLET, COATED in 1 BLISTER PACK
NDC 56062-0198-04
🏷️ FDA NDC (as labeled) 56062-198-04 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 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

🆔 Identity & classification

FDA NDC (as labeled) 56062-198-04
Product NDC 56062-198
11-digit billing NDC 56062019804
RxCUI 1110988
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID 01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148
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 2019-09-13
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 56062-198-04 — 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 → 56062-0198-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

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

🏭 Manufacturer & labeler

LabelerPUBLIX SUPER MARKETS INC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code56062
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio112 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

🧪 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 commonly used as a cough suppressant. Guaifenesin functions as an expectorant to help thin mucus and make coughs more productive. Phenylephrine is a decongestant typically used 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
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 mg 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 —
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 —
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 —
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 — — FDA listed —
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 — — FDA listed —
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 — — FDA listed —
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 mgthis 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 — — FDA listed —
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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
56062-0198-04 You're viewing this 2 BLISTER PACK in 1 CARTON (56062-198-04) / 10 TABLET, COATED in 1 BLISTER PACK 2021-03-01 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 56062-198-04, 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: 56062-0198-04, written without dashes as 56062019804. 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 56062-0198-04, the first segment (56062) is the labeler code FDA assigned to PUBLIX SUPER MARKETS INC; the middle segment (0198) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 PUBLIX SUPER MARKETS INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PUBLIX SUPER MARKETS 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.

📄 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
🎯 Indications and Usage 47 words ▾

Uses temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat sinus congestion and pressure 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 35 words ▾

Inactive ingredients colloidal silicon dioxide, 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 56062-0197-04 · PUBLIX 56062-0204-21 · Publix →
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.