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Cold Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 10 mg; 5 mg Tablet, Coated — NDC 41520-0603-02 package photo

Cold Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 10 mg; 5 mg Tablet, Coated

by American Sales Company · 2 BLISTER PACK in 1 CARTON (41520-603-02) / 12 TABLET, COATED in 1 BLISTER PACK
NDC 41520-0603-02
🏷️ FDA NDC (as labeled) 41520-603-02 billing pads the product 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) 41520-603-02
Product NDC 41520-603
11-digit billing NDC 41520060302
RxCUI 1094538
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 0cc66c6c-db26-4bb2-a97d-c4106210d70c
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 2011-09-01
Marketing end 2027-06-30
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 41520-603-02 — 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 → 41520-0603-02. 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

LabelerAmerican Sales Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code41520
First marketedSep 2011
Product typeHuman Otc Drug
Portfolio100 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter coated tablet taken by mouth, containing three active ingredients commonly combined for cold and congestion relief. Acetaminophen is typically used to reduce fever and relieve pain and aches. Dextromethorphan is commonly used to suppress cough. Phenylephrine is typically used as a nasal decongestant to help relieve stuffy nose and sinus congestion. This product is marketed under the FDA's over-the-counter monograph rules for cold and cough medicines.

Supplement & herbal interactions

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

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 mg 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 mgthis 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

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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
41520-0603-02 You're viewing this 2 BLISTER PACK in 1 CARTON (41520-603-02) / 12 TABLET, COATED in 1 BLISTER PACK 2011-09-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 41520-603-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 41520-0603-02, written without dashes as 41520060302. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 41520-0603-02, the first segment (41520) is the labeler code FDA assigned to American Sales Company; the middle segment (0603) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but American Sales Company has reported a marketing end date of 2027-06-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
American Sales Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 25 words ▾

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

⏱️ Dosage and Administration 50 words ▾

Directions do not take more than directed (see overdose warning ) 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 12 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 12 caplets in 24 hours, which is the maximum daily amount 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. 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

📦 Storage and Handling 16 words ▾

Other information store between 20°-25°C (68°-77°F) in a dry place retain carton for complete product information

🧪 Active Ingredient 23 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

🎯 Purpose 23 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 41520-0582-19 · American 41520-0604-62 · American →
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.