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Cold Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl 325 mg; 10 mg; 5 mg Tablet, Film Coated — NDC 70000-0652-01 package photo

Cold Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl 325 mg; 10 mg; 5 mg Tablet, Film Coated

by Cardinal Health 110, LLC. DBA Leader · 2 BLISTER PACK in 1 CARTON (70000-0652-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK
NDC 70000-0652-01
🏷️ FDA NDC (as labeled) 70000-0652-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70000-0652-1
Product NDC 70000-0652
11-digit billing NDC 70000065201
RxCUI 1094538
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
UPC 0096295143027
Application # M012
SPL Set ID 0c94780d-e901-43fc-ad8a-80c5d61ea47b
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-25
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 70000-0652-1 — 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 → 70000-0652-01. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health 110, LLC. DBA Leader
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedOct 2023
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.

🩺 Clinical

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an oral tablet marketed as an over-the-counter cold and multi-symptom relief product under FDA's OTC monograph rules. It contains acetaminophen, which is typically used to reduce fever and relieve pain, along with dextromethorphan, commonly used to suppress cough. The product also includes phenylephrine, which functions as a nasal decongestant to help reduce congestion. The tablet is film-coated for easier swallowing.

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.

💊 What it looks like

Color white
ShapeOval
Imprint44;470
Size17 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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 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.

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

The official label also statescorn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, 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.

💲 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 $0.094 $2.25 / 24 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Aug 2026 Sep 2026 $0.095 $0.094
▼ Down 1% over the last 2 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Multi-Symptom Mapap Cold Formula 325 mg/1; 10 mg/1; 5 mg 00904-5786-24 Major 12 tablets $0.094 — Availability likely —
Cold Max 5 mg/1; 325 mg/1; 10 mg 46122-0410-62 AmeriSource 12 tablets $0.094 — Availability likely —
Cold Relief Multi-Symptom 325 mg/1; 10 mg/1; 5 mgthis 70000-0652-01 Cardinal 12 tablets $0.094 — Availability likely —
Theraflu ExpressMax Daytime Severe Cold and Cough 325 mg/1; 10 mg/1; 5 mg 00067-8136-10 Haleon 10 tablets — — FDA listed —
Cold Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 30142-0470-08 Kroger 12 tablets — — FDA listed —
Cold plus Head Congestion 325 mg/1; 10 mg/1; 5 mg 36800-0514-02 TOPCO 12 tablets — — FDA listed —
Cold Max 325 mg/1; 10 mg/1; 5 mg 36800-0521-05 TOPCO 12 tablets — — FDA listed —
Cold Max Daytime 10 mg/1; 5 mg/1; 325 mg 36800-0921-05 TopCo 12 tablets — — FDA listed —
Cold Plus Head Congestion Daytime 325 mg/1; 10 mg/1; 5 mg 36800-0924-02 TopCo 12 tablets — — FDA listed —
Cold Relief 325 mg/1; 10 mg/1; 5 mg 41163-0907-08 United 12 tablets — — FDA listed —
Cold Multi-Symptom Daytime 325 mg/1; 10 mg/1; 5 mg 41520-0138-05 American 12 tablets — — FDA listed —
Cold Head Congestion Daytime 325 mg/1; 10 mg/1; 5 mg 41520-0603-02 American 12 tablets — — FDA listed —
Medique Cold Cough Product 10 mg/1; 325 mg/1; 5 mg 47682-0108-36 Unifirst 2 tablets — — FDA listed —
Cold Max 325 mg/1; 10 mg/1; 5 mg 53943-0138-05 DISCOUNT 12 tablets — — FDA listed —
Cold Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 55301-0470-08 ARMY 12 tablets — — FDA listed —
Multi-Symptom Mapap Cold Formula 325 mg/1; 10 mg/1; 5 mg 63187-0652-24 Proficient 12 tablets — — FDA listed —
Multi-Symptom Cold Daytime 325 mg/1; 10 mg/1; 5 mg 63941-0470-08 Valu 12 tablets — — FDA listed —
Non-Drowsy Max Cold 10 mg/1; 325 mg/1; 5 mg 66715-5628-03 Lil' 2 tablets — — FDA listed —
Cold Max 325 mg/1; 10 mg/1; 5 mg 68998-0238-05 MARC 12 tablets — — FDA listed —
Cold Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 69168-0324-86 Allegiant 12 tablets — — FDA listed —
Cold Max 325 mg/1; 10 mg/1; 5 mg 72036-0138-05 Harris 12 tablets — — FDA listed —
Medique Cold Cough Product 10 mg/1; 325 mg/1; 5 mg 85766-0162-36 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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
70000-0652-01 You're viewing this 2 BLISTER PACK in 1 CARTON (70000-0652-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2023-10-25 Active

📄 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
🎯 Indications and Usage 35 words ▾

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache nasal congestion cough sore throat sinus congestion and pressure temporarily reduces fever helps clear nasal passages promotes nasal and sinus drainage

⏱️ 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: blisters rash skin reddening 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease 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, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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 36 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

🧪 Active Ingredient 16 words ▾

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

🧪 Inactive Ingredients 25 words ▾

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

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0650-01 · Cardinal 70000-0653-01 · 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.