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Guaifenesin 200mg 200 mg Tablet, 3,000-count — NDC 71610-434-18 (Billing 71610-0434-18)

by Aphena Pharma Solutions - Tennessee, LLC · 3000 TABLET in 1 BOTTLE

This is a package of 3,000 tablets of Guaifenesin 200mg 200 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since Mar 2019 and currently FDA-listed. It is this product's only package size.

NDC 71610-0434-18
🏷️ FDA NDC (as labeled) 71610-434-18 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

NDC database record

One package, one record: these facts belong to NDC 71610-434-18 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71610 labeler · 434 product · 18 package
Package marketed since
Jun 16, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
3,000 EA per package
Barcode (UPC-A, from the NDC)
3 7161043418 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71610-434-18
Product NDC 71610-434
11-digit billing NDC 71610043418
NCPDP billing unit EA — each (per item)
RxCUI 197741
UNII 495W7451VQ
Application # M012
SPL Set ID 45ac210a-8c54-4469-8e10-e6fe52b89cb5
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 2019-03-01
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43200010000320
GPI class guaiFENesin
GCN Seq No 000761
GCN 02482
HICL code 000271
Ingredient (HICL) Guaifenesin
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3J
Therapeutic class — specific (HIC3) Expectorants
AHFS code 48:16.00.00
AHFS class Expectorants
FDB label name GUAIFENESIN 200 MG TABLET
FDB brand name Guaifenesin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 000761
  • GCN: 02482
  • GPI-14 (Medi-Span): 43200010000320
  • HICL (First Databank): 000271
  • AHFS class code: 48:16.00.00
  • RxCUI (RxNorm): 197741
Why two NDCs? The FDA registers this code as 71610-434-18 — 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 → 71610-0434-18. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
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 GUAIFENESIN 200 MG TABLET Ingredient Guaifenesin
📖 What it is MedlinePlus · NLM

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Guaifenesin doesn't suppress your cough — it actually makes it work better. It loosens and thins the mucus in your chest so your cough can move it out of your airways more effectiv...
  • What exactly does guaifenesin do — does it actually stop my cough?
  • No — extended-release tablets like 12 Hour Mucus Relief and 365 Whole Foods Market Guaifenesin must be swallowed whole. Crushing, chewing, or breaking them releases the medicine al...
  • Can I crush or split the extended-release tablet to make it easier to swallow?
📖 Read our full Guaifenesin guide →
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
71610-0434-18 You're viewing this Main listing 3000 TABLET in 1 BOTTLE 2020-06-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Guaifenesin 200 mg 00904-5154-60 Major 100 tablets $0.032 — Availability likely —
Guaifenesin 200mg 200 mg 10135-0789-01 Marlex 100 tablets — — FDA listed —
Air Power 200 mg 53499-0232-01 Schwabe 100 tablets — — FDA listed —
Mucus Relief 200 mg 54738-0980-01 Richmond 100 tablets — — FDA listed —
Guaifenesin 200mg 200 mg 69517-0148-03 HEALTHLIFE 300 tablets — — Discontinued —
Mucus Relief 200 mg 71610-0098-18 Aphena 3000 tablets — — FDA listed —
Guaifenesin 200mg 200 mgthis 71610-0434-18 Aphena 3000 tablets — — FDA listed —
Guaifenesin 200mg 200 mg 71679-0148-02 Health 200 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
Mar 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

LabelerAphena Pharma Solutions - Tennessee, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code71610
First marketedMar 2019
Product typeHuman Otc Drug
Portfolio800 products on file

More NDCs from Aphena Pharma Solutions - Tennessee, LLC labeler code 71610

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 47 words ▾

Directions: Do not take more than 6 doses in any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: do not use

⚠️ Warnings 111 words ▾

Warnings Ask a doctor before use if you have Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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.

🧪 Active Ingredient 7 words ▾

Active ingredient (in each tablet) Guaifenesin 200mg

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev: 02/19TCL

🎯 Purpose 6 words ▾

Purpose Expectorant Guaifenesin 200 mg Tablets

📄 Stop Use and Ask a Doctor If 47 words ▾

Stop use and ask a doctor if cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

🤰 If Pregnant or Breast-Feeding 12 words ▾

If pregnant or breast- feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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

📄 Package Label / Principal Display Panel 17 words ▾

PRINCIPAL DISPLAY PANEL - 200 mg NDC 71610-434 - Guaifenesin 200 mg Tablets Bottle Label 200 mg

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
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

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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, 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.
← 71610-0433-15 · Aphena 71610-0435-45 · Aphena →
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.