Home › NDC Lookup › Ingredients › Acetaminophen Dextromethorphan Hbr Guaif... › 70000-0525-01
⚪image loading
(from DailyMed)

Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated — NDC 70000-0525-1 (Billing 70000-0525-01)

by Cardinal Health 110, LLC. DBA Leader · 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated from Cardinal Health 110, LLC. DBA Leader, marketed since Oct 2019 and currently FDA-listed; retail pharmacies pay about $0.1321 per unit (NADAC). It is this product's only package size.

NDC 70000-0525-01
🏷️ FDA NDC (as labeled) 70000-0525-1 billing pads the package 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0525-1
Product NDC 70000-0525
11-digit billing NDC 70000052501
NCPDP billing unit EA — each (per item)
RxCUI 1110988
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0096295138603
Application # M012
SPL Set ID 610accad-2f8b-4605-9357-a58e6e18d417
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 2019-10-25
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 SEVERE COLD-FLU CAPLET
FDB brand name Severe Cold-Flu
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 70000-0525-1 — a 5-4-1 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 package segment → 70000-0525-01. 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 SEVERE COLD-FLU 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 film-coated tablet containing four active ingredients typically used to relieve multiple cold and flu symptoms. Acetaminophen is a pain reliever and fever reducer, while dextromethorphan is commonly used to suppress cough. Guaifenesin functions as an expectorant to help thin mucus and make coughs more productive. Phenylephrine is a decongestant typically used to relieve nasal congestion. This product is marketed under FDA's over-the-counter monograph rules for cold and flu symptom relief.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.132 $3.17 / 24 tablets
Medicaid paysCMS SDUD · 12 mo $0.1860 $4.46 / 24 tablets
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.210 $0.113
▼ Down 11% over the last 24 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
70000-0525-01 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK 2019-10-25 — 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 mgthis 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 +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 —
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
Oct 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.

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.

Manufacturer & labeler

LabelerCardinal Health 110, LLC. DBA Leader
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio163 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.

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 64 words ▾

Principal display panel LEADER♥ ™ NDC 70000-0525-1 Severe Cold & Flu Acetaminophen | Dextromethorphan HBr Guaifenesin | Phenylephrine HCl Pain Reliever / Fever Reducer | Cough Suppressant Expectorant | Nasal Decongestant Headache, Fever, Sore Throat, Nasal Congestion, Cough, Mucus, Chest Congestion 24 CAPLETS Actual Size COMPARE TO TYLENOL ® COLD + FLU SEVERE active ingredients † 100% Money Back Guarantee Leader 44-503A Leader 44-503A

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
105
Units reimbursed last 4 qtrs
4K
Gross reimbursed last 4 qtrs
$750.07
Avg / prescription
$7.14
Avg / unit
$0.1860
Latest quarter Q1 2026
31Rx
Medicaid pays / ea
$0.1860
gross reimbursed
vs
NADAC / ea
$0.1321
acquisition cost
=
Spread
+$0.0539
+41% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 105 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 4,032 units · 13.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
13.213.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Texas 13.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 70000-0523-01 · Cardinal 70000-0526-01 · CARDINAL →
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.