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Respiratory Relief GUAIFENESIN 400 mg Tablet, 30-count — NDC 53499-5295-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Respiratory Relief GUAIFENESIN 400 mg Tablet, 30-count — NDC 53499-5295-0 (Billing 53499-5295-00)

by Schwabe North America, Inc · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Respiratory Relief GUAIFENESIN 400 mg Tablet from Schwabe North America, Inc, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 53499-5295-00
🏷️ FDA NDC (as labeled) 53499-5295-0 billing pads the package 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) 53499-5295-0
Product NDC 53499-5295
11-digit billing NDC 53499529500
RxCUI 359601
UNII 495W7451VQ
UPC 0033674152959
Application # M012
SPL Set ID f683041a-4ff9-42a5-9047-a9a3140a8758
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 2025-07-29
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 359601
Why two NDCs? The FDA registers this code as 53499-5295-0 — 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 → 53499-5295-00. 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

📖 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
53499-5295-00 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2025-07-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Mucus Relief 400 mg 63868-0998-50 Chain 50 tablets $0.063 — FDA listed —
Rugby Chest Congestion Relief G450 400 mg 00536-1311-08 Rugby 60 tablets $0.066 — Availability likely —
Good Neighbor Pharmacy Mucus Relief 400 mg 24385-0602-65 AmerisourceBergen 30 tablets $0.066 — Availability likely —
Guaifenesin 400 mg 24689-0144-01 APNAR 100 tablets $0.066 — Availability likely —
Mucus Relief 400 mg 46122-0794-61 Amerisource 50 tablets $0.066 — Availability likely —
Leader Chest Congestion Relief G450 400 mg 70000-0055-01 Cardinal 60 tablets $0.066 — Availability likely —
Foster and Thrive Chest Congestion Relief 400 mg 70677-1054-01 Strategic 50 tablets $0.066 — Availability likely —
HealthMart Chest Congestion Relief 400 mg 62011-0060-01 Strategic 50 tablets $0.066 — FDA listed —
Chest Congestion Relief 400 mg 49348-0729-09 Strategic 24 tablets $0.067 — FDA listed —
Mucus Relief 400 mg 00363-0532-01 Walgreen 30 tablets — — FDA listed —
Guaifenesin 400mg 400 mg 10135-0790-30 Marlex 30 tablets — — FDA listed —
DG Health Immediate Release Mucus Relief 400 mg 10956-0059-30 Reese 30 tablets — — FDA listed —
Refenesen Mucus Relief 400 mg 10956-0845-30 Reese 30 tablets — — FDA listed —
Guaifenesin 400 mg 16103-0379-04 Pharbest 30 tablets — — FDA listed —
Mucus Relief 400 mg 17714-0152-01 Advance 100 tablets — — FDA listed —
Kroger Mucus Relief 400 mg 30142-0471-30 THE 30 tablets — — FDA listed —
TopCare Chest Congestion Relief 400 mg 36800-0794-50 TOPCO 50 tablets — — FDA listed —
Mucus Relief 400 mg 37835-0401-40 Bi-Mart 40 tablets — — FDA listed —
Equaline Chest Congestion Relief 400 mg 41163-0113-50 United 50 tablets — — FDA listed —
Mucus Relief 400 mg 41226-0272-03 KROGER 30 tablets — — FDA listed —
Meijer Chest Congestion Relief 400 mg 41250-0713-50 Meijer 50 tablets — — FDA listed —
Mucosa 400 mg 49483-0272-00 TIME 100000 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 50804-0371-30 Good 30 tablets — — FDA listed —
Mucus Relief 400 mg 50804-0857-30 Good 30 tablets — — Discontinued —
Respiratory Relief 400 mgthis 53499-5295-00 Schwabe 30 tablets — — FDA listed —
Mucosa Guifenesin 400 mg 54257-0776-21 Magno-Humphries, 60 tablets — — FDA listed —
Mucus Relief 400 mg 54738-0981-30 Richmond 30 tablets — — FDA listed —
Family Wellness Chest Congestion Relief 400 mg 55319-0891-30 Family 30 tablets — — FDA listed —
Mucus Relief 400 mg 55681-0311-03 TWIN 300 tablets — — FDA listed —
Guaifenesin 400 400 mg 57631-0012-00 InvaTech 28000 tablets — — FDA listed —
Mucus Relief 400 mg 57896-0714-01 Geri-Care 100 tablets — — FDA listed —
Mucus Relief 400 mg 57896-0794-01 Geri-Care 100 tablets — — FDA listed —
Always Save Chest Congestion Relief GUAF 400 mg 63941-0987-50 Valu 50 tablets — — FDA listed —
Mucus Relief 400 mg 66424-0001-01 SDA 100 tablets — — FDA listed —
Mucus Relief 400 mg 68210-4158-01 Prodose, 15 tablets — — FDA listed —
Marcs Mucus Relief 400 mg 68998-0845-50 Marc 50 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 69168-0370-01 Allegiant 100 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 69168-0916-60 Allegiant 60 tablets — — Discontinued —
Mucus Relief 400 mg 69517-0005-02 HealthLife 200 tablets — — Discontinued —
Guaifenesin 400 mg 69618-0061-06 Reliable 60 tablets — — FDA listed —
Mucus Relief 400 mg 71335-1035-01 Bryant 30 tablets — — FDA listed —
Mucus Relief 400 mg 71335-2032-01 Bryant 30 tablets — — FDA listed —
Guaifenesin 400 mg 71335-9616-01 Bryant 30 tablets — — FDA listed —
Mucus Relief 400 mg 71679-0119-02 Health 200 tablets — — FDA listed —
Guaifenesin 400 mg 71679-0309-00 Health 38500 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0009-02 Pioneer 300 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0013-01 Pioneer 200 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0019-01 Pioneer 200 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0035-01 Pioneer 200 tablets — — FDA listed —
Mucus Relief 400 mg 72090-0044-01 Pioneer 200 tablets — — FDA listed —
Pharbinex 400 mg 73057-0379-04 Ulai 30 tablets — — FDA listed —
Mucus Relief Immediate Release 400 mg 76162-0004-01 TopCo 100 tablets — — FDA listed —
SIMPEX Guaifenesin 400 mg 76457-0004-00 Simpex 100 tablets — — FDA listed —
Guaifenesin 400Mg Caplets 400 mg 77333-0360-10 Gendose 100 tablets — — FDA listed —
Chest Congestion Relief 400 mg 79481-0714-05 Meijer, 50 tablets — — FDA listed —
Mucus Relief 400 mg 82725-1012-01 Cabinet 200 tablets — — FDA listed —
Quality Choice Mucus Relief 400 mg 83324-0194-50 Chain 50 tablets — — FDA listed —
Mucus Relief 400 mg 84324-0009-01 NUVICARE 100 tablets — — FDA listed —
Mucus Relief 400 mg 57896-0718-01 Geri-Care 100 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white
ShapeOval
Imprint400
Size18 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.

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

LabelerSchwabe North America, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53499
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio20 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 24 words ▾

Indications & Usage Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

⏱️ Dosage and Administration 91 words ▾

Dosage & Administration Adults & children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not to exceed 6 tablets in 24 hours. Children under 12 years of age: do not use.

Purpose Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. Indications & Usage Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

⚠️ Warnings 11 words ▾

Warnings Do not use for children under 12 years of age.

🆘 Overdosage 16 words ▾

Overdosage: In case of overdose, seek medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Guaifenesin 400 mg

🧪 Inactive Ingredients 16 words ▾

Inactive Ingredients Carnauba Wax Cellulose Glycerin Hypromellose Magnesium Stearate Maltodextrin Povidone Silica Sodium Croscarmellose Stearic Acid

🎯 Purpose 22 words ▾

Purpose Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

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 ✓ 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 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 Schwabe North America, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Schwabe North America, Inc 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.
← 53499-5272-05 · Schwabe 53499-5522-03 · Schwabe →
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.