Home › NDC Lookup › Ingredients › Acetaminophen Dextromethorphan Hbr Guaif... › 50804-0503-08
Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated — NDC 50804-0503-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated — NDC 50804-503-08 (Billing 50804-0503-08)

by Geiss, Destin & Dunn Inc. · 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated from Geiss, Destin & Dunn Inc., marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.

NDC 50804-0503-08
🏷️ FDA NDC (as labeled) 50804-503-08 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 50804-503-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50804 labeler · 503 product · 08 package
Package marketed since
Jun 9, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0846036009125
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50804-503-08
Product NDC 50804-503
11-digit billing NDC 50804050308
NCPDP billing unit EA — each (per item)
RxCUI 1110988
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0846036009125
Application # M012
SPL Set ID a7d2eaee-484e-43aa-8ae3-0e050219383f
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 2020-06-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

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

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 GS COLD-FLU SEVERE CAPLET
FDB brand name Cold-Flu Severe
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 060553
  • GCN: 26742
  • HICL (First Databank): 035445
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1110988
Why two NDCs? The FDA registers this code as 50804-503-08 — 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 → 50804-0503-08. 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 GS COLD-FLU SEVERE CAPLET Ingredient Phenylephrine/Dm/Acetaminop/Gg
📖 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 over-the-counter monograph oral tablet containing four active ingredients commonly found in multi-symptom cold and flu products. Acetaminophen is typically used to reduce fever and relieve pain or aches. Dextromethorphan is a cough suppressant often used to reduce coughing. Guaifenesin functions as an expectorant, meaning it is commonly used to help thin mucus and make it easier to cough up. Phenylephrine is a nasal decongestant typically used to help relieve nasal congestion related to colds or flu.

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
50804-0503-08 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK 2020-06-09 — 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 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 — — 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 mgthis 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 —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow
ShapeOval
Imprint44;503
Size19 mm
ScoringNot scored
FlavorMenthol
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 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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • 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 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 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.

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

The official label also statescorn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, 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

LabelerGeiss, Destin & Dunn Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50804
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Geiss, Destin & Dunn Inc. labeler code 50804

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

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

⏱️ Dosage and Administration 46 words ▾

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve 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. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 diabetes heart disease thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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. In case of overdose, get medical help or contact a Poison Control Center right away.

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

📦 Storage and Handling 42 words ▾

Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

🧪 Active Ingredient 19 words ▾

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

🎯 Purpose 9 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant 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 50 words ▾

Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure difficulty in urination due to enlargement of the 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 43 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 128 words ▾

Principal display panel GOODSENSE® NDC 50804-503-08 Cold + Flu Severe Acetaminophen / Pain Reliever/Fever Reducer Dextromethorphan HBr / Cough Suppressant Guaifenesin / Expectorant Phenylephrine HCl / Nasal Decongestant Headache, Fever, Sore Throat, Cough, Nasal Congestion, Mucus, Chest Congestion *Compare to the active ingredients of Tylenol® COLD + FLU SEVERE 24 Caplets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® COLD + FLU SEVERE.

50844 REV0125D50308 Distributed by: Perrigo Direct, Inc., Peachtree City, GA 30269 www.PerrigoDirect.com (1-800-426-9391) GoodSense® is a registered trademark of L. Perrigo Company. GoodSense 44-503A GoodSense 44-503A

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 Cold and Flu Severe (this brand).

Top reported reactions

Toxicity To Various Agents2
Anaphylactic Reaction1
Chest Pain1
Choking1
Device Difficult To Use1
Disease Progression1
Erythema1

Age at onset

Adult3
Elderly1

Reporter sex

11 reports
Male · 27%
Female · 73%

Serious outcomes

Hospitalization4
Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Geiss, Destin & Dunn Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Geiss, Destin & Dunn 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.
← 50804-0432-30 · Good 50804-0551-02 · GoodSense →
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.