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Guaifenesin 1200 mg Tablet, Extended Release

by Aurohealth LLC · 3 BLISTER PACK in 1 CARTON (58602-865-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
NDC 58602-0865-03
🏷️ FDA NDC (as labeled) 58602-865-03 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) 58602-865-03
Product NDC 58602-865
11-digit billing NDC 58602086503
RxCUI 310621
UNII 495W7451VQ
Application # ANDA210453
SPL Set ID 4ec1477e-6e33-4c40-a476-cf7f4f00192b
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 2021-03-11
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN
Why two NDCs? The FDA registers this code as 58602-865-03 — 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 → 58602-0865-03. 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.

🏭 Manufacturer & labeler

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA210453 (ANDA)
Labeler code58602
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio175 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

📗 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.

🧪 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
Mucus Relief ER 1200 mg 00536-1249-71 Rugby 14 tablets $0.432 — Availability likely —
Rugby Mucus Relief ER 1200 mg 00536-1451-88 Rugby 7 tablets $0.432 — Availability likely —
good neighbor pharmacy mucus er 1200 mg 46122-0683-74 Amerisource 1 tablet $0.432 — Availability likely —
Good Neighbor Pharmacy Mucus ER 1200 mg 46122-0814-04 Amerisource 7 tablets $0.432 — Availability likely —
Leader Mucus Relief 1200 mg 70000-0721-01 Cardinal 7 tablets $0.432 — Availability likely —
Mucus Relief 1200 mg 70000-0730-01 LEADER/ 14 tablets $0.432 — Availability likely —
Mucus Relief 1200 mg 70677-1051-01 Strategic 1 tablet $0.432 — Availability likely —
Guaifenesin 1200 mg 70677-1258-01 Strategic 14 tablets $0.432 — Availability likely —
Mucus Relief 1200 mg 83324-0096-14 CHAIN 14 tablets $0.432 — Availability likely —
Mucus Relief Extended Release Maximum Strength 1200 mg 70000-0479-01 CARDINAL 14 tablets $0.469 — FDA listed —
Good Sense Mucus ER 1200 mg 00113-3650-00 L. 14 tablets — — FDA listed —
Good Sense Mucus ER 1200 mg 00113-4077-01 L. 7 tablets — — FDA listed —
Guaifenesin 1200 mg 00363-0033-01 WALGREEN 14 tablets — — FDA listed —
Guaifenesin 1200 mg 00363-0570-27 Walgreens 14 tablets — — FDA listed —
Mucus Relief Extended Release Maximum Strength 1200 mg 00363-0832-14 Walgreens 14 tablets — — FDA listed —
Mucus Relief 1200 mg 00536-1392-88 Rugby 1 tablet — — FDA listed —
Mucus Relief Extended Release 1200 mg 11673-0732-14 TARGET 14 tablets — — FDA listed —
Guaifenesin 1200 mg 11673-0840-27 TARGET 14 tablets — — FDA listed —
Guaifenesin 1200 mg 11822-4260-01 RITE 14 tablets — — FDA listed —
Mucus Relief Max 1200 mg 21130-0399-01 Better 14 tablets — — FDA listed —
Guaifenesin 1200 mg 21130-0554-27 Safeway, 14 tablets — — FDA listed —
Guaifenesin 1200 mg 25000-0041-12 MARKSANS 500 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 30142-0962-14 Kroger 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 36800-0932-14 TOP 14 tablets — — Discontinued —
Mucus Relief Extended Release Maximum Strength 1200 mg 37808-0762-14 H 14 tablets — — FDA listed —
Mucus Relief 1200 mg 37835-0412-28 Bi-Mart 28 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 41226-0724-89 KROGER 14 tablets — — FDA listed —
mucus relief 1200 mg 41250-0654-02 Meijer 14 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 41415-0997-14 PUBLIX 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 41520-0732-14 Care 14 tablets — — FDA listed —
mucus er 1200 mg 42507-0471-14 HyVee 7 tablets — — FDA listed —
Guaifenesin 1200 mg 43598-0009-25 Dr. 14 tablets — — FDA listed —
Guaifenesin 1200 mg 43598-0108-37 Dr. 14 tablets — — FDA listed —
Equate Mucus Relief 1200 mg 49035-0284-48 Wal-Mart 48 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 49483-0724-70 TIME 70 tablets — — FDA listed —
Mucinex Maximum Strength 1200 mg 50090-2301-00 A-S 7 tablets — — Discontinued —
mucus extended release 1200 mg 51316-0400-55 CVS 7 tablets — — FDA listed —
Mucus And Chest Congestion 1200 mg 51316-0520-74 CVS 7 tablets — — FDA listed —
Mucus Relief 1200 mg 51316-0724-94 CVS 14 tablets — — FDA listed —
mucus relief 1200 mg 51316-0728-74 CVS 7 tablets — — FDA listed —
Guaifenesin 1200 mg 51660-0567-54 Ohm 14 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 53041-0191-48 Guardian 7 tablets — — FDA listed —
Guaifenesin Extended-Release 1200 mg 53041-0234-37 Guardian 7 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 53942-0204-02 Demoulas 14 tablets — — FDA listed —
Mucus Relief Max 1200 mg 53943-0234-07 Discount 14 tablets — — FDA listed —
Mucus Relief 1200 mg 55319-0551-07 Family 1 tablet — — FDA listed —
Mucus Relief 1200 mg 55319-0733-14 Family 1 tablet — — FDA listed —
dg health mucus er max 1200 mg 55910-0626-74 Dolgencorp 14 tablets — — FDA listed —
DG health mucus er max 1200 mg 55910-0887-74 Dolgencorp 7 tablets — — FDA listed —
Crcle Guaifensin Extended Release Tablet, 1200 mg 57483-0280-02 Innovus 56 tablets — — FDA listed —
Giltuss EX Maximum Strength Expectorant 1200 mg 58552-0341-07 Gil 7 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0811-01 Aurohealth 14 tablets — — FDA listed —
Guaifenesin 1200 mgthis 58602-0865-03 Aurohealth 14 tablets — — FDA listed —
Mucus Relief 1200 mg 59726-0237-07 P 1 tablet — — FDA listed —
Mucus Relief 1200 mg 61504-0204-02 AMERIFOODS 14 tablets — — FDA listed —
Guaifenesin 1200 mg 62207-0569-93 Granules 2000 tablets — — FDA listed —
Guaifenesin 1200 mg 62207-0840-71 Granules 10 tablets — — FDA listed —
Mucinex Maximum Strength 1200 mg 63824-0023-02 Reckitt 1 tablet — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 63868-0148-14 CHAIN 7 tablets — — FDA listed —
Guaifenesin 1200 mg 65162-0037-03 Amneal 30 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 67091-0404-02 WINCO 7 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 68196-0033-56 SAM'S 14 tablets — — FDA listed —
Guaifenesin 1200 mg 68196-0405-14 SAM'S 56 tablets — — FDA listed —
Guaifenesin 1200 mg 68196-0960-56 Sam's 14 tablets — — FDA listed —
Guaifenesin Extended Release 1200 mg 68196-0996-56 SAM'S 14 tablets — — FDA listed —
berkley and jensen mucus relief 1200 mg 68391-0000-45 BJWC 14 tablets — — FDA listed —
Mucus Relief 1200 mg 68391-0724-95 BJWC 84 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 69168-0460-32 Allegiant 100 tablets — — FDA listed —
Guaifenesin 1200 mg 69842-0335-16 CVS 14 tablets — — FDA listed —
Mucus Relief Extended Release Maximum Strength 1200 mg 69842-0732-14 CVS 14 tablets — — FDA listed —
Guaifenesin 1200 mg 69848-0018-16 GRANULES 14 tablets — — FDA listed —
Guaifenesin 1200 mg 71309-0461-56 Safrel 56 tablets — — FDA listed —
Mucus Relief Maximum Strength 1200 mg 72036-0204-02 HARRIS 14 tablets — — FDA listed —
Mucus Relief 1200 mg 72090-0012-01 Pioneer 100 tablets — — FDA listed —
basic care mucus er max 1200 mg 72288-0613-55 Amazon.com 7 tablets — — FDA listed —
basic care mucus er max 1200 mg 72288-0650-02 Amazon.com 14 tablets — — FDA listed —
Curist Mucus Relief Maximum Strength 1200 mg 72559-0013-11 Little 14 tablets — — FDA listed —
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mg 73581-0402-01 YYBA 100 tablets — — FDA listed —
Guaifenesin 1200 mg 76162-0031-56 TOPCO 14 tablets — — FDA listed —
Topcare Mucus ER 1200 mg 76162-0409-01 Topco 7 tablets — — FDA listed —
Topcare Mucus ER 1200 mg 76162-0523-01 Topco 14 tablets — — FDA listed —
Mucus Relief 1200 mg 79481-1204-01 Meijer 14 tablets — — FDA listed —
equate mucus relief 1200 mg 79903-0327-14 WALMART 7 tablets — — FDA listed —
Betr chest congestion relief 1200 mg 80267-0002-74 Live 14 tablets — — FDA listed —
Betr remedies chest congestion relief 1200 mg 80267-0010-74 Live 1 tablet — — FDA listed —
Guaifenesin 1200 mg 80513-0413-11 Advanced 110 tablets — — FDA listed —
Expectorant Guaifenesin Extended-Release 1200 mg 81179-0007-04 YET 70 tablets — — FDA listed —
Mucus Relief 1200 mg 81522-0204-02 FSA 14 tablets — — FDA listed —
Up And Up Mucus Relief 1200 mg 82442-0503-01 Target 7 tablets — — FDA listed —
Guaifenesin - Odaat 1200 Mg 83139-0175-01 LODAAT 100 tablets — — FDA listed —
Mucus Relief 1200 mg 84324-0034-01 NUVICARE 24 tablets — — FDA listed —
Dr Simi Mucus Relief Expectorant 1200 mg 85786-0301-14 Farmacias 14 tablets — — FDA listed —
Guaifenesin 1200 mg 71179-0002-21 VESPYR 7 tablets — — FDA listed —
Guaifenesin 1200 mg 58602-0857-93 Aurohealth 14 tablets — — FDA listed —
Mucus Relief 1200 mg 73581-0403-01 YYBA 100 tablets — — FDA listed —
Maximum Strength Mucus Relief 1200 mg 70677-1320-01 Strategic 14 tablets — — FDA listed —
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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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
58602-0865-03 You're viewing this 3 BLISTER PACK in 1 CARTON (58602-865-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2021-03-11 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 58602-865-03, 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: 58602-0865-03, written without dashes as 58602086503. 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 58602-0865-03, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0865) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aurohealth 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 22 words ▾

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

⏱️ Dosage and Administration 60 words ▾

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings 11 words ▾

Warnings Do not use for children under 12 years of age

📦 Storage and Handling 10 words ▾

Other information store between 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 11 words ▾

Active ingredient ( in each extended-release tablet) Guaifenesin USP 1200 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

🎯 Purpose 2 words ▾

Purpose Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58602-0864-98 · Aurohealth 58602-0867-09 · Aurohealth →
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.