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Guaifenesin and Dextromethorphan Hydrobromide 400 mg; 20 mg Tablet, 26,500-count — NDC 57631-0013-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guaifenesin and Dextromethorphan Hydrobromide 400 mg; 20 mg Tablet, 26,500-count — NDC 57631-013-10 (Billing 57631-0013-10)

by InvaTech Pharma Solutions LLC · 26500 TABLET in 1 BOX

This is a package of 26,500 tablets of Guaifenesin and Dextromethorphan Hydrobromide 400 mg; 20 mg Tablet from InvaTech Pharma Solutions LLC, marketed since Jan 2021 and currently FDA-listed. It is this product's only package size.

NDC 57631-0013-10
🏷️ FDA NDC (as labeled) 57631-013-10 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 57631-013-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57631 labeler · 013 product · 10 package
Package marketed since
Jan 13, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5763101310 8
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57631-013-10
Product NDC 57631-013
11-digit billing NDC 57631001310
RxCUI 1147685
UNII 495W7451VQ, 9D2RTI9KYH
Application # M012
SPL Set ID 40288ecf-043d-eb9e-e063-6394a90ac0a7
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 2021-01-13
Route ORAL
Dosage form TABLET
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1147685
Why two NDCs? The FDA registers this code as 57631-013-10 — 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 → 57631-0013-10. 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.

Clinical

📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 Read our full Dextromethorphan / Guaifenesin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
57631-0013-10 You're viewing this Main listing 26500 TABLET in 1 BOX 2021-01-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Mucus Relief DM DM 20 mg/1; 400 mg 63868-0753-50 Chain 50 tablets $0.074 — FDA listed —
Sunmark Chest Congestion Relief DM DM 20 mg/1; 400 mg 49348-0728-09 Strategic 50 tablets $0.080 — FDA listed —
Rugby Chest Congestion Relief DM 20 mg/1; 400 mg 00536-1312-08 Rugby 60 tablets $0.082 — Availability likely —
Good Neighbor Pharmacy Mucus Relief DM 20 mg/1; 400 mg 24385-0026-71 AmerisourceBergen 50 tablets $0.082 — Availability likely —
Mucus Relief DM Cough 20 mg/1; 400 mg 46122-0790-61 Amerisource 50 tablets $0.082 — Availability likely —
Leader Chest Congestion Relief DM 20 mg/1; 400 mg 70000-0056-01 Cardinal 60 tablets $0.082 — Availability likely —
Mucus Relief DM Cough Maximum Strength 20 mg/1; 400 mg 70000-0278-01 Cardinal 12 tablets $0.082 — Availability likely —
Foster and Thrive Chest Congestion Relief DM DM 20 mg/1; 400 mg 70677-1055-01 Strategic 50 tablets $0.082 — Availability likely —
Quality Choice Mucus Relief DM DM 20 mg/1; 400 mg 83324-0195-50 Chain 50 tablets $0.082 — Availability likely —
Mucus Relief DM 20 mg/1; 400 mg 00363-0533-01 Walgreen 30 tablets — — FDA listed —
Refenesen Mucus Relief DM 20 mg/1; 400 mg 10956-0846-30 Reese 30 tablets — — FDA listed —
Pharbinex-Dm 400 mg/1; 20 mg 16103-0381-04 Pharbest 30 tablets — — FDA listed —
Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 17714-0150-60 Advance 60 tablets — — FDA listed —
Kroger Chest Congestion Relief DM 20 mg/1; 400 mg 30142-0472-30 THE 30 tablets — — FDA listed —
TopCare Chest Congestion and Cough Relief DM 20 mg/1; 400 mg 36800-0988-50 TOPCO 30 tablets — — FDA listed —
Mucus Relief Dm 20 mg/1; 400 mg 37835-0403-40 Bi-Mart 40 tablets — — FDA listed —
Equaline Chest Congestion Relief DM DM 20 mg/1; 400 mg 41163-0114-50 United 50 tablets — — FDA listed —
Mucus Relief Dm 20 mg/1; 400 mg 41226-0280-03 KROGER 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 41250-0533-11 Meijer 60 tablets — — FDA listed —
Guaifenesin DM 400 mg/1; 20 mg 43063-0801-60 PD-Rx 60 tablets — — FDA listed —
Medique Medi-Mucus 20 mg/1; 400 mg 47682-0432-46 Unifirst 1 tablet — — FDA listed —
Mucosa Dm 400 mg/1; 20 mg 49483-0280-00 TIME 100000 tablets — — FDA listed —
Mucus Relief DM Immediate Release 20 mg/1; 400 mg 50804-0432-30 Good 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 50804-0858-30 Good 30 tablets — — Discontinued —
Mucus Relief DM Cough 20 mg/1; 400 mg 50844-0633-11 L.N.K. 60 tablets — — FDA listed —
Mucosa DM 20 mg/1; 400 mg 54257-0277-01 Magno-Humphries, 50 tablets — — FDA listed —
Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 54738-0985-30 Richmond 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 55301-0533-01 ARMY 10 tablets — — FDA listed —
Family Wellness Chest Congestion Relief DM DM 20 mg/1; 400 mg 55319-0890-30 Family 30 tablets — — FDA listed —
Dollar General Chest Congestion Relief DM 20 mg/1; 400 mg 55910-0272-30 Dolgencorp, 30 tablets — — FDA listed —
Chest Congestion Relief DM 20 mg/1; 400 mg 55910-0533-01 DOLGENCORP, 30 tablets — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 400 mg/1; 20 mgthis 57631-0013-10 InvaTech 26500 tablets — — FDA listed —
Mucus Relief Xpect 400 mg/1; 20 mg 63654-0342-20 Selder, 20 tablets — — FDA listed —
Always Save Chest Congestion Relief DM 20 mg/1; 400 mg 63941-0985-50 Valu 50 tablets — — FDA listed —
Marcs Chest Congestion Relief DM 20 mg/1; 400 mg 68998-0114-50 Marc 50 tablets — — FDA listed —
Mucus Relief DM Immediate Release 20 mg/1; 400 mg 69168-0432-07 Allegiant 10 tablets — — FDA listed —
CVS Chest Congestion Relief DM 20 mg/1; 400 mg 69842-0996-30 CVS 30 tablets — — FDA listed —
RIGHT REMEDIES Mucus Relief DM 20 mg/1; 400 mg 70692-0181-25 Strive 250 tablets — — FDA listed —
Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 71335-1928-01 Bryant 30 tablets — — FDA listed —
Rugby Chest Congestion Relief DM 20 mg/1; 400 mg 71335-2216-01 Bryant 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 72090-0027-01 Pioneer 150 tablets — — FDA listed —
Care One Chest Congestion Relief DM 20 mg/1; 400 mg 72476-0871-50 RETAIL 50 tablets — — FDA listed —
Pharbinex-DM 400 mg/1; 20 mg 73057-0381-04 Ulai 30 tablets — — FDA listed —
Mucus Relief Xpect 400 mg/1; 20 mg 76095-0012-20 Midway 20 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 76162-0008-01 TopCo 100 tablets — — FDA listed —
Mucus DM 20 mg/1; 400 mg 79481-5330-01 Meijer 60 tablets — — FDA listed —
Mucus Relief Dm 20 mg/1; 400 mg 80513-0407-09 Advanced 90 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 84324-0035-01 NUVICARE 100 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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.

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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesColloidal Silicon Di oxide USP/NF, Hypromellose 5 [Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder

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.

Manufacturer & labeler

LabelerInvaTech Pharma Solutions LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code57631
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from InvaTech Pharma Solutions LLC labeler code 57631

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⚠️ Warnings 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 3 words ▾

cough cold, allergic

⚠️ Warnings 12 words ▾

KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

🧪 Inactive Ingredients 48 words ▾

Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder

🎯 Purpose 6 words ▾

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

📄 Keep Out of Reach of Children 7 words ▾

KEEP OUT OF THE REACH OF CHILDREN

📄 Package Label / Principal Display Panel 1 words ▾

Label

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 Guaifenesin and Dextromethorphan Hydrobromide — the ingredient across all brands.

Top reported reactions

Dizziness864
Diarrhoea641
Accidental Overdose543
Nausea515
Overdose390
Somnolence300
Headache293

Age at onset

Child3
Adolescent2
Adult160
Elderly169

Reporter sex

7,324 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization586
Life-threatening44
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 663 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.

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 InvaTech Pharma Solutions LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
InvaTech Pharma Solutions 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.
← 57631-0012-00 · InvaTech 57631-0016-00 · InvaTech →
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.