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MAXIMUM STRENGTH Sinus Relief Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate Kit — NDC 76162-0824-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MAXIMUM STRENGTH Sinus Relief Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate Kit — NDC 76162-824-12 (Billing 76162-0824-12)

by Topco Associates LLC · 1 KIT in 1 CARTON * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of MAXIMUM STRENGTH Sinus Relief Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate Kit from Topco Associates LLC, marketed since Dec 2023 and currently FDA-listed. It is this product's only package size.

NDC 76162-0824-12
🏷️ FDA NDC (as labeled) 76162-824-12 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 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76162-824-12
Product NDC 76162-824
11-digit billing NDC 76162082412
RxCUI 1297288, 1656815, 2634364
Application # M012
SPL Set ID 0f2be061-bd0a-4e62-b994-6d0768ea647a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-25
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1297288
Why two NDCs? The FDA registers this code as 76162-824-12 — 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 → 76162-0824-12. 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

🧪 What is this product?

This is an over-the-counter combination kit containing multiple active ingredients typically used together to manage sinus congestion and cold symptoms. Acetaminophen functions as a pain reliever and fever reducer, while dextromethorphan is commonly used to suppress cough. Guaifenesin is typically included as an expectorant to help thin mucus, and phenylephrine hydrochloride functions as a decongestant to relieve nasal congestion. Doxylamine succinate is an antihistamine commonly used to reduce sneezing and runny nose. As an OTC monograph product, this kit is marketed under established FDA guidelines for this category of multi-ingredient cold and sinus remedies.

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
76162-0824-12 You're viewing this Main listing 1 KIT in 1 CARTON * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2023-12-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold and Flu Severe Daytime/Nighttime 76162-0823-12 Topco 12 capsules — — FDA listed —
MAXIMUM STRENGTH Sinus Reliefthis 76162-0824-12 Topco 8 capsules — — FDA listed —
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu 49035-0796-02 Wal-Mart 2 tablets — — FDA listed —
basic care daytime severe cold and flu nighttime severe cold and flu 72288-0002-90 Amazon.com 2 tablets — — FDA listed —
daytime cold and flu nighttime cold and flu 79481-5200-00 Meijer, 2 tablets — — FDA listed —
dg health day time severe cold and flu relief night time severe cold and flu relief 55910-0643-90 Dolgencorp, 2 tablets — — FDA listed —
basic care daytime severe cold and flu nighttime cold and flu 72288-0502-72 Amazon.com 2 tablets — — FDA listed —
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct 42507-0106-42 HyVee 12 capsules — — 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
Dec 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.

What it looks like

Color orange / green
ShapeOval
Imprint812
Size2 mm
ScoringNot scored
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.

From the label’s inactive-ingredient sectionedible printing ink, FD&C Blue no. 1, FD&C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution edible printing ink, FD&C Blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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

LabelerTopco Associates LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio408 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 83 words ▾

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses • temporarily relieves: • nasal congestion • headache • cough • minor aches & pains • sinus congestion & pressure • runny nose and sneezing • temporarily promotes nasal and/or sinus drainage

⏱️ Dosage and Administration 98 words ▾

Directions • do not take more than directed (see Overdose warning) • do not take more than 12 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use

Directions • do not take more than directed (see Overdose warning) • do not take more than 12 softgels in any 24-hour period • adults and children 12 years of age and older: take 2 softgels every 4 hours • children under 12 years of age: do not use

⚠️ Warnings ~3 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these 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.

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin When using these products • do not use more than directed. Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • pain, nasal congestion, or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 12 softgels in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products 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.

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to enlarged prostate gland • glaucoma • a breathing problem such as emphysema or chronic bronchitis • 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 • taking sedatives or tranquilizers When using these products • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery 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… [Excerpted — this section continues on DailyMed.]

📦 Storage and Handling 28 words ▾

Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture

Other information • store at 20-25°C (68-77°F) • protect from light, heat and moisture

🧪 Active Ingredient 41 words ▾

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

Active ingredients (in each softgel) NIGHT Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 50 words ▾

Inactive ingredients edible printing ink, FD&C Blue no. 1, FD&C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Inactive ingredients edible printing ink, FD&C Blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

🎯 Purpose 16 words ▾

Purposes Pain reliever Cough suppressant Expectorant Nasal decongestant

Purposes Pain reliever Cough suppressant Antihistamine Nasal decongestant

📄 Keep Out of Reach of Children 46 words ▾

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 10 words ▾

Questions or comments? Call: 1-888-423-0139

Questions or comments? Call: 1-888-423-0139

📄 Package Label / Principal Display Panel 2 words ▾

Packaging Topco-824

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates LLC 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.
← 76162-0823-12 · Topco 76162-0836-34 · Topco →
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.