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topcare mucus d guaifenesin and pseudoephedrine hydrochloride 600 mg; 60 mg Tablet, Multilayer, Extended Release

by Topco Associates LLC · 18 BLISTER PACK in 1 CARTON (76162-801-89) / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
NDC 76162-0801-89
🏷️ FDA NDC (as labeled) 76162-801-89 billing pads the product segment with a zero
OTC Generic 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) 76162-801-89
Product NDC 76162-801
11-digit billing NDC 76162080189
UNII 495W7451VQ, 6V9V2RYJ8N
Application # ANDA214407
SPL Set ID 02134afa-ae8c-4678-a19a-7fd3cab5782f
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-16
Route ORAL
Dosage form TABLET, MULTILAYER, EXTENDED RELEASE
Substance GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 76162-801-89 — 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 → 76162-0801-89. 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.

🏭 Manufacturer & labeler

LabelerTopco Associates LLC
Application holderL PERRIGO CO
FDA applicationANDA214407 (ANDA)
Labeler code76162
First marketedAug 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.

🩺 Clinical

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
foster and thrive mucus relief d 600 mg/1; 60 mg 70677-1272-01 Strategic 18 tablets $0.387 — Availability likely —
Rugby Mucus Relief D 600 mg/1; 60 mg 00536-1449-21 Rugby 18 tablets $0.387 — Availability likely —
mucus D 600 mg/1; 60 mg 00113-8307-68 L. 18 tablets $0.387 — Availability likely —
Leader Mucus Relief D 600 mg/1; 60 mg 70000-0720-01 Cardinal 18 tablets $0.387 — Availability likely —
Guaifenesin D 600 mg/1; 60 mg 00536-1333-21 RUGBY 18 tablets $0.387 — Availability likely —
Mucinex D 600 mg/1; 60 mg 63824-0057-18 Reckitt 18 tablets $0.704 — FDA listed —
Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1; 60 mg 00363-0077-18 WALGREEN 18 tablets — — FDA listed —
Guaifenesin D 600 mg/1; 60 mg 00363-9930-18 Walgreen 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1; 60 mg 41415-0994-18 PUBLIX 18 tablets — — FDA listed —
Guaifenesin D 600 mg/1; 60 mg 51316-0993-18 CVS 18 tablets — — FDA listed —
Guaifenesin and Pseudoephedrine Hydrochloride 600 mg/1; 60 mg 62011-0475-01 STRATEGIC 18 tablets — — FDA listed —
Mucinex D 600 mg/1; 60 mg 50090-1076-00 A-S 9 tablets — — FDA listed —
topcare mucus d 600 mg/1; 60 mgthis 76162-0801-89 Topco 1 tablet — — FDA listed —
Mucus D 600 mg/1; 60 mg 51316-0878-68 CVS 18 tablets — — FDA listed —
Mucus D 600 mg/1; 60 mg 79481-0709-01 Meijer, 18 tablets — — FDA listed —
Mucinex D 600 mg/1; 60 mg 50090-1075-00 A-S 18 tablets — — FDA listed —
mucus relief d 600 mg/1; 60 mg 59640-0621-89 H 18 tablets — — FDA listed —
Mucus Relief D 600 mg/1; 60 mg 00363-8708-68 Walgreen 18 tablets — — FDA listed —
mucus d 600 mg/1; 60 mg 30142-0739-68 Kroger 18 tablets — — FDA listed —
equate mucus d 600 mg/1; 60 mg 79903-0125-18 WALMART 18 tablets — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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
76162-0801-89 You're viewing this 18 BLISTER PACK in 1 CARTON (76162-801-89) / 1 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK 2023-08-16 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 — Not published for this NDC No photo available yet for this listing.
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

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 76162-801-89, 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: 76162-0801-89, written without dashes as 76162080189. 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 76162-0801-89, the first segment (76162) is the labeler code FDA assigned to Topco Associates LLC; the middle segment (0801) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (89) 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: 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.

📄 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 61 words ▾

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 60 words ▾

Directions • do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for timing of meals • adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours • children under 12 years of age: do not use

⚠️ Warnings 194 words ▾

Warnings Do not use 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 • 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, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • do not use more than directed Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache.

These could be signs of a serious illness. 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 (1-800-222-1222).

📦 Storage and Handling 19 words ▾

Other information • do not use if printed blister unit is broken or torn • store between 20-25˚C (68-77˚F)

🧪 Active Ingredient 14 words ▾

Active ingredients (in each extended-release bi-layer tablet) Guaifenesin 600 mg Pseudoephedrine HCl 60 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

🎯 Purpose 4 words ▾

Purposes Expectorant Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76162-0792-04 · Topco 76162-0804-01 · 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.