Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL Solution — NDC 57237-0312-51 package photo

Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL Solution

by Rising Pharma Holdings, Inc. · 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05)
NDC 57237-0312-51
🏷️ FDA NDC (as labeled) 57237-312-51 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 57237-312-51
Product NDC 57237-312
11-digit billing NDC 57237031251
NCPDP billing unit ML — per mL (volume)
RxCUI 996520
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012.85
SPL Set ID e463e60f-d0db-4ee7-9713-ddf25aa38a43
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 2023-06-12
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
GPI-14 43997002520910
GCN Seq No 000652
GCN 53491
HICL code 000223
Ingredient (HICL) Guaifenesin/Dextromethorphan
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 B3T
Therapeutic class — specific (HIC3) Non-Opioid Antitussive And Expectorant Combination
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name GUAIFENESN-DM 100-10MG/5ML CUP
FDB brand name Guaifenesin-Dextromethorphan
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57237-312-51 — 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 → 57237-0312-51. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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

LabelerRising Pharma Holdings, Inc.
FDA applicationM012.85 (OTC MONOGRAPH DRUG)
Labeler code57237
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio525 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

Label name GUAIFENESN-DM 100-10MG/5ML CUP Ingredient Guaifenesin/Dextromethorphan
📗 Our plain-language guide HelloPharmacist
  • The two ingredients tackle your symptoms from different angles. Guaifenesin is an expectorant — it helps thin and loosen the mucus in your chest so you can cough it up more easily....
  • What exactly does this combination do — why are two ingredients needed?
  • It depends on which antidepressant you're taking. If it's a type called an MAOI — which includes certain older antidepressants and some medications for Parkinson's disease — you sh...
  • Can I take this if I'm on an antidepressant?
📖 Read our full Dextromethorphan / 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.

💊 What it looks like

Color red
FlavorCherry
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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $0.405 $202.55 / 500 ml
Medicaid paysCMS SDUD · 12 mo $0.2017 $100.85 / 500 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
May 2025 $0.405 $0.405
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
Chest Congestion Relief DM 10 mg/5mL; 100 mg/5mL 00536-1313-85 RUGBY 473 ml $0.009 Availability likely save 98%
Tusnel Diabetic 10 mg/5mL; 100 mg/5mL 54859-0505-04 LLORENS 118 ml $0.011 Availability likely save 97%
Mucolyte DM 100 mg/5mL; 10 mg/5mL 57237-0360-12 Rising 118 ml $0.011 Availability likely save 97%
Tussin DM Regular 20 mg/10mL; 200 mg/10mL 82568-0014-04 AARNA 1 bottle $0.011 Availability likely save 97%
Tussin DM Sugar free 20 mg/10mL; 200 mg/10mL 82568-0015-04 AARNA 1 bottle $0.011 Availability likely save 97%
Tussin DM Cough and Chest Congestion Non Drowsy 20 mg/10mL; 200 mg/10mL 63868-0868-54 QUALITY 1 bottle $0.018 FDA listed save 96%
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0504-08 Method 237 ml $0.023 Availability likely save 94%
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0505-08 Method 237 ml $0.023 Availability likely save 94%
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mLthis 57237-0312-51 Rising 100 cups $0.405 Availability likely
Dextromethorphan HBr and Guaifenesin Oral Solution 100 mg/5mL; 10 mg/5mL 81033-0103-50 KESIN 100 cups $0.405 Availability likely
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 00121-0638-00 PAI 10 cups FDA listed
Guaifenesin Dm 200 mg/10mL; 20 mg/10mL 00121-1276-00 PAI 10 cups FDA listed
Guaifenesin and Dextromethorphan 100 mg/5mL; 10 mg/5mL 00904-7512-70 Major 10 cups FDA listed
Guaifenesin and Dextromethorphan 200 mg/10mL; 20 mg/10mL 00904-7513-72 Major 10 cups FDA listed
Carolina Crud Crusher 200 mg/10mL; 20 mg/10mL 11383-0311-08 Weeks 236 ml FDA listed
Target Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 11673-0775-08 TARGET 1 bottle FDA listed
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 17856-1126-01 ATLANTIC 72 cups FDA listed
Adult Cough and Chest Congestion Relief DM Non Drowsy 20 mg/10mL; 200 mg/10mL 21130-0385-04 Safeway, 1 bottle FDA listed
Tussin DM Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 21130-0583-04 Safeway, 1 bottle FDA listed
Tussin Cough Sugar Free 20 mg/10mL; 200 mg/10mL 49580-0834-04 P 1 bottle FDA listed
Tukol Sugar Free Cough and Cold 2 mg/mL; 20 mg/mL 50066-0505-04 Genomma 1 bottle FDA listed
Sorbugen 15 mg/7.5mL; 150 mg/7.5mL 52083-0660-16 Kramer 480 ml FDA listed
Defensol Adult Syrup 200 mg/10mL; 20 mg/10mL 53145-0039-04 Menper 1 bottle FDA listed
Cosedal Drops 10 mg/5mL; 100 mg/5mL 53145-0059-02 Menper 1 bottle FDA listed
Adult Bisolvine Adult 20 mg/10mL; 200 mg/10mL 53145-0323-04 MENPER 120 ml FDA listed
Altituss 15 mg/7.5mL; 150 mg/7.5mL 53163-0113-16 Alternative 473 ml FDA listed
Tussin DM Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 53942-0503-26 DeMoulas 237 ml FDA listed
Tussin DM 10 mg/5mL; 100 mg/5mL 53943-0503-26 Discount 237 ml FDA listed
Limpia Pecho 10 mg/5mL; 100 mg/5mL 54859-0011-04 Llorens 118 ml FDA listed
Tusnel SF 10 mg/5mL; 100 mg/5mL 54859-0506-04 Llorens 118 ml FDA listed
Tusnel Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 54859-0509-16 Llorens 473 ml FDA listed
Llorens Care Tussin DM 10 mg/5mL; 100 mg/5mL 54859-0833-04 Llorens 118 ml FDA listed
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5783-05 Cardinal 5 cups FDA listed
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5785-05 Cardinal 5 cups FDA listed
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 57237-0313-18 Rising 80 cups FDA listed
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 57243-0503-24 Salado 118 ml FDA listed
Geri-Tussin DM 20 mg/10mL; 200 mg/10mL 57896-0291-16 Geri-Care 473 ml FDA listed
Geri-Tussin DM 10 mg/5mL; 100 mg/5mL 57896-0661-08 Geri-Care 237 ml FDA listed
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 57896-0736-04 Geri-Care 118 ml FDA listed
Guaiasorb Dm 20 mg/10mL; 200 mg/10mL 57896-0739-04 Geri-Care 118 ml FDA listed
Giltuss HBP Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 58552-0132-04 Gil 1 bottle FDA listed
Giltuss Childrens Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 58552-0133-04 Gil 1 bottle FDA listed
Giltuss Diabetic Cough and Cold 200 mg/10mL; 20 mg/10mL 58552-0134-04 Gil 1 bottle FDA listed
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 58552-0140-04 Gil 1 bottle FDA listed
Childrens Giltuss Honey Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 58552-0141-04 Gil 1 bottle FDA listed
Rompe Pecho DM 10 mg/5mL; 100 mg/5mL 58593-0275-04 Efficient 118 ml Discontinued
Rompe Pechito DM for Kids 5 mg/2.5mL; 50 mg/2.5mL 58593-0276-04 Efficient 118 ml FDA listed
Guaifenesin DM 100 mg/5mL; 10 mg/5mL 60687-0817-17 American 10 cups FDA listed
Guaifenesin DM 200 mg/10mL; 20 mg/10mL 60687-0828-56 American 10 cups FDA listed
ACTINEL Diabetic 10 mg/5mL; 100 mg/5mL 63102-0140-16 ACTIPHARMA, 473 ml FDA listed
Tussin Cough DM Sugar Free 20 mg/10mL; 200 mg/10mL 63868-0869-04 QUALITY 1 bottle FDA listed
Cough and Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 63941-0817-04 Best 1 bottle FDA listed
Childrens Giltuss Honey Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 65852-0003-04 Dextrum 1 bottle FDA listed
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0005-04 Dextrum 1 bottle FDA listed
Giltuss HBP Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0006-04 Dextrum 1 bottle FDA listed
Giltuss Diabetic 20 mg/10mL; 200 mg/10mL 65852-0009-04 Dextrum 1 bottle FDA listed
Giltuss Childrens Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 65852-0019-04 Dextrum 1 bottle FDA listed
SDA Laboratories Tussin DM 10 mg/5mL; 100 mg/5mL 66424-0565-16 SDA 473 ml FDA listed
Adult Tussin DM Lil Drug Store Products 10 mg/5mL; 100 mg/5mL 66715-6858-04 Lil' 1 bottle FDA listed
Tussin DM Cough and Chest Non Drowsy 20 mg/10mL; 200 mg/10mL 67091-0265-18 WinCo 1 bottle FDA listed
Tussin DM Cough and Chest 20 mg/10mL; 200 mg/10mL 67091-0469-04 WinCo 1 bottle FDA listed
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 68071-3938-04 NuCare 118 ml FDA listed
Sorbutuss NR 10 mg/5mL; 100 mg/5mL 68436-0120-16 Dextrum 474 ml FDA listed
Tussin DM 10 mg/5mL; 100 mg/5mL 69168-0477-66 Allegiant 1 bottle FDA listed
Tussin Cough and Chest Congestion DM adult 20 mg/10mL; 200 mg/10mL 69256-0385-08 Harris 1 bottle FDA listed
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0149-19 Natco 10 cups FDA listed
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0150-19 Natco 10 cups FDA listed
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0035-04 OPMX 118 ml FDA listed
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0036-04 OPMX 118 ml FDA listed
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0069-04 OPMX 118 ml FDA listed
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0812-04 OPMX 118 ml FDA listed
Akin Cough Formula DM 10 mg/5mL; 100 mg/5mL 69822-0202-04 Southern 118 ml FDA listed
MAX Tussin Cough and Chest Congestion DM 20 mg/10mL; 200 mg/10mL 71399-0025-04 Akron 1 bottle FDA listed
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 71399-0026-04 Akron 1 bottle FDA listed
Guaifenesin DM 10 mg/5mL; 100 mg/5mL 71800-0057-05 Innovida 119 ml FDA listed
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 72162-2277-02 Bryant 237 ml FDA listed
Guaifed DM 200 mg/10mL; 20 mg/10mL 73564-0802-04 Aldama 118 ml FDA listed
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 76281-0503-24 AptaPharma 118 ml FDA listed
Revasol Tussin DM Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 84379-0316-16 Rnv 474 ml FDA listed
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 84415-0011-01 Everpharm 100 cups FDA listed
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 84415-0014-01 Everpharm 100 cups FDA listed
Curewell Tussin DM 20 mg/10mL; 200 mg/10mL 85111-0802-16 RMT 473 ml FDA listed
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 85722-0001-04 KJD 118 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 57237-0312-51, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
172
Units reimbursed last 4 qtrs
25.8K
Gross reimbursed last 4 qtrs
$5.2K
Avg / prescription
$30.31
Avg / unit
$0.2017
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.2017
gross reimbursed
vs
NADAC / mL
$0.4051
acquisition cost
=
Spread
−$0.2034
-50% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
33% FFS 67% MCO
Fee-for-service · 56 Rx Managed care · 116 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 2,113 units · 27.0 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,400 units · 24.4 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 3,677 units · 28.4 per 100k residents PA New Jersey: 9,260 units · 99.7 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 7,483 units · 121 per 100k residents MO Kentucky: 1,913 units · 42.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
24.4121
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Missouri 121 /100k
2 New Jersey 99.7 /100k
3 Kentucky 42.3 /100k
4 Pennsylvania 28.4 /100k
5 Washington 27.0 /100k
6 Minnesota 24.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Dextromethorphan HBr. and Guaifenesin — the ingredient across all brands.

Top reported reactions

Covid-1910
Disease Recurrence7
Dyspnoea7
Asthenia6
Cardiac Arrest5
Cough5
Fall5

Reporter sex

0 reports
Male · 46%
Female · 54%

Serious outcomes

Death10
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 10 0
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 NDCDescription Marketing startStatus
57237-0312-51 You're viewing this 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05) 2023-06-12 Active

📄 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 31 words

Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

⏱️ Dosage and Administration 92 words

Directions • do not take more than 6 doses in any 24 hour period 20 mg-200 mg/10 mL age dose Children under 12 years of age Do not use Adults and children over 12 years of age 10 mL (1 unit dose) every 4 hours 10 mg-100 mg/5 mL age dose Children under 6 years of age Do not use Children 6 to under 12 years of age 5 mL (1 unit dose) every 4 hours Adults and children over 12 years of age 10 mL (2 unit dose) every 4 hours

⚠️ Warnings 155 words

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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 persistant headache.

These could be signs of a serious condition. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📦 How Supplied / Storage and Handling 79 words

NDC Information - Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms: NDC 57237-312-05 unit dose cup 5mL NDC 57237-312-51 (100 x 5 mL) unit-dose cups Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 57237-313-01 unit dose cup 10mL NDC 57237-313-18 (80 x 10 mL) unit-dose cups

🧪 Active Ingredient 42 words

DRUG FACTS 10 mg-100 mg/5 mL - Active ingredient per 5 mL (1 unit dose) Dextromethorphan HBr. 10 mg Guaifenesin 100 mg 20 mg-200 mg/10 mL - Active ingredient per 10 mL (1 unit dose) Dextromethorphan HBr. 20 mg Guaifenesin 200 mg

🧪 Inactive Ingredients 18 words

Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

🎯 Purpose 4 words

Purpose Cough Suppressant Expectorant

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.