Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Curewell Tussin Guaifenesin 100 mg/5mL Liquid, 473 mL — NDC 85111-693-16 (Billing 85111-0693-16)
by RMT HEALTH LLC · 473 mL in 1 BOTTLE
This is a package of 473 mL of Curewell Tussin Guaifenesin 100 mg/5mL Liquid from RMT HEALTH LLC, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.
NDC 85111-0693-16
🏷️ FDA NDC (as labeled)
85111-693-16
billing pads the product segment with a zero
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
85111-693-16
Product NDC
85111-693
11-digit billing NDC
85111069316
RxCUI
310604
UNII
495W7451VQ
UPC
0385111693168
Application #
M012
SPL Set ID
47455587-5074-e70d-e063-6294a90a78bb
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
2025-12-01
Route
ORAL
Dosage form
LIQUID
Substance
GUAIFENESIN
Quick answers
- RxCUI (RxNorm): 310604
Why two NDCs?
The FDA registers this code as 85111-693-16 — 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 → 85111-0693-16. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Guaifenesin — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Guaifenesin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 85111-0693-16 You're viewing this Main listing | 473 mL in 1 BOTTLE | 2025-12-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Chest Congestion Relief 100 mg/5mL 00536-1314-85 | RUGBY | 473 ml | $0.011 | — | Availability likely | — |
| Guaifenesin 100 mg/5mL 58657-0508-16 | Method | 473 ml | $0.011 | — | Availability likely | — |
| Guaifenesin 100 mg/5mL 83720-0503-16 | Oncor | 473 ml | $0.011 | — | Availability likely | — |
| Guaifenesin 100 mg/5mL 58657-0509-16 | Method | 473 ml | $0.013 | — | FDA listed | — |
| Good Neighbor Adult Tussin Mucus and chest congestion 200 mg/10mL 46122-0785-29 | AMERISOURCE | 1 bottle | $0.023 | — | Availability likely | — |
| Tusnel EX 100 mg/5mL 54859-0507-04 | Llorens | 118 ml | $0.023 | — | Availability likely | — |
| Mucolyte 100 mg/5mL 57237-0359-12 | Rising | 118 ml | $0.023 | — | Availability likely | — |
| Tussin 200 mg/10mL 70677-1186-01 | Strategic | 1 bottle | $0.023 | — | Availability likely | — |
| Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 82568-0012-04 | AARNA | 1 bottle | $0.023 | — | Availability likely | — |
| QCH Adult Tussin 541 200 mg/10mL 83324-0024-04 | Chain | 1 bottle | $0.023 | — | Availability likely | — |
| Mucinex Fast-Max Chest Congestion Honey and Berry Flavor 400 mg/20mL 63824-0537-66 | Reckitt | 180 ml | $0.061 | — | FDA listed | — |
| Guaifenesin 100 mg/5mL 00121-0744-04 | PAI | 118 ml | — | — | FDA listed | — |
| Guaifenesin 200 mg/10mL 00121-1488-00 | PAI | 10 cups | — | — | FDA listed | — |
| Guaifenesin 100 mg/5mL 00121-1744-00 | PAI | 10 cups | — | — | FDA listed | — |
| Guaifenesin 300 mg/15mL 00121-2232-00 | PAI | 10 cups | — | — | FDA listed | — |
| Walgreen Cherry 200 mg/10mL 00363-7043-08 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Childrens Chest Congestion Relief 100 mg/5mL 00363-7504-04 | WALGREENS | 1 bottle | — | — | FDA listed | — |
| Tusnel EX 100 mg/5mL 50090-6542-00 | A-S | 118 ml | — | — | FDA listed | — |
| CVS Adult Mucus plus Chest Congestion 200 mg/10mL 51316-0437-08 | CVS | 1 bottle | — | — | FDA listed | — |
| CVS Adult Mucus chest congestion 200 mg/10mL 51316-0743-08 | CVS | 1 bottle | — | — | FDA listed | — |
| Tussin 100 mg/5mL 53943-0507-26 | Discount | 237 ml | — | — | FDA listed | — |
| Childrens Chest Congestion Relief Grape 100 mg/5mL 53943-0511-24 | Discount | 118 ml | — | — | FDA listed | — |
| Llorens Care Tussin 100 mg/5mL 54859-0510-16 | Llorens | 473 ml | — | — | FDA listed | — |
| Guaifenesin 200 mg/10mL 55154-5780-05 | Cardinal | 5 cups | — | — | FDA listed | — |
| Guaifenesin 100 mg/5mL 55154-9450-05 | Cardinal | 5 cups | — | — | FDA listed | — |
| Geri-Tussin 200 mg/10mL 57896-0293-16 | Geri-Care | 473 ml | — | — | FDA listed | — |
| Geri-Tussin 100 mg/5mL 57896-0693-16 | Geri-Care | 473 ml | — | — | FDA listed | — |
| Cough Out 100 mg/5mL 58593-0255-04 | Efficient | 118 ml | — | — | Discontinued | — |
| Rompe Pecho SF 100 mg/5mL 58593-0265-04 | Efficient | 118 ml | — | — | Discontinued | — |
| Rompe Pecho EX 200 mg/10mL 58593-0829-04 | Efficient | 118 ml | — | — | FDA listed | — |
| Guaifenesin 100 mg/5mL 60687-0852-17 | American | 10 cups | — | — | FDA listed | — |
| Guaifenesin 200 mg/10mL 60687-0863-56 | American | 10 cups | — | — | FDA listed | — |
| Guaifenesin 300 mg/15mL 60687-0874-16 | American | 10 cups | — | — | FDA listed | — |
| Childrens Mucus Relief Chest Congestion 100 mg/5mL 63868-0770-04 | Chain | 1 bottle | — | — | FDA listed | — |
| SDA Laboratories Tussin 100 mg/5mL 66424-0563-16 | SDA | 473 ml | — | — | FDA listed | — |
| DRx Choice Fruit Punch 200 mg/10mL 68163-0743-04 | Raritan | 1 bottle | — | — | FDA listed | — |
| Adult Tussin 200 mg/10mL 69230-0332-23 | Camber | 1 bottle | — | — | FDA listed | — |
| Reliable-1 Tussin 100 mg/5mL 69618-0068-54 | RELIABLE | 118 ml | — | — | FDA listed | — |
| Akin 100 mg/5mL 69822-0200-02 | Southern | 118 ml | — | — | FDA listed | — |
| MAX Tussin Mucus and Chest Congestion Sugar Free 200 mg/10mL 71399-0024-04 | Akron | 1 bottle | — | — | FDA listed | — |
| MAX Tussin Mucus and Chest Congestion 200 mg/10mL 71399-0054-08 | Akron | 1 bottle | — | — | FDA listed | — |
| Guaifenesin STRAWBERRY-BANANA FLAVOR 100 mg/5mL 71800-0059-19 | Innovida | 119 ml | — | — | FDA listed | — |
| Guaifenesin 100 mg/5mL 72162-2278-02 | Bryant | 473 ml | — | — | FDA listed | — |
| Guaifed 200 mg/10mL 73564-0801-04 | Aldama | 118 ml | — | — | FDA listed | — |
| Tussin Expectorant 100 mg/5mL 76281-0507-24 | AptaPharma, | 118 ml | — | — | FDA listed | — |
| Meijer Adult Mucus Plus chest congestion 200 mg/10mL 79481-7430-08 | MEIJER | 1 bottle | — | — | FDA listed | — |
| Guaifenesin 100 mg/5mL 81033-0102-51 | KESIN | 50 cups | — | — | FDA listed | — |
| Quality Choice Adult Tussin Expectorant 200 mg/10mL 83324-0332-04 | QUALITY | 1 bottle | — | — | FDA listed | — |
| Curewell Tussin 100 mg/5mLthis 85111-0693-16 | RMT | 473 ml | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.
- FDA Orange Book · refreshed Sep 3, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII L7T10EIP3A
A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerRMT HEALTH LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code85111
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio8 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Recent Major Changes
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
⏱️ Dosage and Administration ▾
Directions do not take more than 6 doses in a 24 hour period do not exceed recommended dose adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours (10mL to 20mL) children under 12 years ask a doctor
⚠️ Warnings ▾
Warnings Do not use if you ever had an allergic reaction to any of the ingredients in this product Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
🧪 Active Ingredient ▾
In each 5 mL teaspoonful Guaifenesin - 100 mg
🧪 Inactive Ingredients ▾
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
🎯 Purpose ▾
Purpose Expectorant
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away
📄 Questions or Comments ▾
Questions or comments? 1-800-540-3765
📄 Recent Major Changes ▾
Fix Typos
📄 Package Label / Principal Display Panel ▾
CurewellTussin
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Curewell Tussin (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 57%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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) | ✓ 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 RMT HEALTH LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RMT HEALTH 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.
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.