Childrens Mucus Relief Chest Congestion Guaifenesin 100 mg/5mL Solution
by Chain Drug Manufacturing Assn · 1 BOTTLE in 1 CARTON (63868-770-04) / 118 mL in 1 BOTTLE
NDC 63868-0770-04
🏷️ FDA NDC (as labeled)
63868-770-04
billing pads the product segment with a zero
OTC
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 →
🆔 Identity & classification
FDA NDC (as labeled)
63868-770-04
Product NDC
63868-770
11-digit billing NDC
63868077004
NCPDP billing unit
ML — per mL (volume)
RxCUI
310604
UNII
495W7451VQ
Application #
M012
SPL Set ID
034d39c0-9aad-4dff-a158-a041b9f0504f
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
2015-10-19
Route
ORAL
Dosage form
SOLUTION
Substance
GUAIFENESIN
GPI-14
43200010000910
GPI class
QC Mucus Relief Childrens
Why two NDCs?
The FDA registers this code as 63868-770-04 — 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 → 63868-0770-04. 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
LabelerChain Drug Manufacturing Assn
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedOct 2015
Product typeHuman Otc Drug
Portfolio4 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
📖 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.
💬 Questions about Guaifenesin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
purple
FlavorGrape
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.
💡 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 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
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 EE90ONI6FF
Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
-
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 OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
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.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate,sorbitol, sucralose, xanthan gum.
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.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 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.
🔁 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/5mLthis 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/5mL 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.
⏳ Availability & generic status
🏛️
2015
On the market since
Oct 2015
📍
2026
Currently FDA-listed
11 years 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.
🔬 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 Childrens Mucus Relief Chest Congestion (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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63868-0770-04 You're viewing this | 1 BOTTLE in 1 CARTON (63868-770-04) / 118 mL in 1 BOTTLE | 2015-10-19 | 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 | ✓ 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 FDA registers it as 63868-770-04, 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: 63868-0770-04, written without dashes as 63868077004. 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 63868-0770-04, the first segment (63868) is the labeler code FDA assigned to Chain Drug Manufacturing Assn; the middle segment (0770) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Chain Drug Manufacturing Assn. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chain Drug Manufacturing Assn 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 ▾
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 ▾
Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products mL = milliliter Age Dose children 6 years to under 12 years 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours children under 4 years do not use
⚠️ Warnings ▾
Warnings Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information each 5 mL contains: sodium 3 mg Tamper evident: do not use if printed inner seal under cap is torn or missing. store at room temperature do not refrigerate dosing cup provided
🧪 Active Ingredient ▾
Active ingredient (in each 5 mL) Guaifenesin, USP 100 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.
🎯 Purpose ▾
Purpose Expectorant
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 ↗
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.