GeriCare Tussin DM Max Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Liquid, 237 mL — NDC 57896-0591-08 package photo

GeriCare Tussin DM Max Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Liquid, 237 mL

by GERI-CARE PHARMACEUTICALS, CORP · 237 mL in 1 BOTTLE (57896-591-08)
NDC 57896-0591-08
🏷️ FDA NDC (as labeled) 57896-591-08 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) 57896-591-08
Product NDC 57896-591
11-digit billing NDC 57896059108
NCPDP billing unit ML — per mL (volume)
RxCUI 1020138
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 47451cd8-7aab-90e2-e063-6394a90ad1b7
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 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
GCN Seq No 023893
GCN 53497
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 TUSSIN DM MAX 400-20MG/20ML LQ
FDB brand name Tussin Dm Max
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 57896-591-08 — 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 → 57896-0591-08. 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

LabelerGERI-CARE PHARMACEUTICALS, CORP
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code57896
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio47 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 TUSSIN DM MAX 400-20MG/20ML LQ Ingredient Guaifenesin/Dextromethorphan
📖 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
  • 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.

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good neighbor pharmacy tussin dm max 20 mg/20mL; 400 mg/20mL 46122-0541-34 Amerisource 1 bottle $0.018 Availability likely
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 70000-0565-01 Cardinal 177 ml $0.020 Discontinued
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 70000-0707-01 Cardinal 177 ml $0.021 Availability likely
QCH Maximum Strength Mucus Relief DM 628 20 mg/20mL; 400 mg/20mL 83324-0026-06 Chain 177 ml $0.021 Availability likely
Good Sense Tussin DM Max 20 mg/20mL; 400 mg/20mL 00113-0927-26 L. 1 bottle $0.024 Availability likely
Good Neighbor Childrens Cough Relief Cherry Flavor 5 mg/5mL; 100 mg/5mL 46122-0786-29 AMERISOURCE 1 bottle $0.024 Availability likely
Tussin DM 20 mg/20mL; 400 mg/20mL 70000-0628-01 Cardinal 1 bottle $0.024 Availability likely
Foster and Thrive Adult Tussin DM MAX 20 mg/20mL; 400 mg/20mL 70677-1036-01 Strategic 1 bottle $0.024 Availability likely
Childrens Delsym Cough Plus Chest Congestion DM 5 mg/5mL; 100 mg/5mL 63824-0214-64 Reckitt 1 bottle $0.059 FDA listed
Mucinex Childrens Cough 5 mg/5mL; 100 mg/5mL 63824-0946-03 Reckitt 1 bottle $0.059 FDA listed
Delsym Cough Plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 63824-0213-66 Reckitt 180 ml $0.062 FDA listed
Mucinex Fast-Max DM Max Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 63824-0535-66 Reckitt 180 ml $0.062 FDA listed
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-2097-01 Haleon 1 bottle FDA listed
Childrens Robitussin Elderberry Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-2098-01 Haleon 1 bottle FDA listed
Childrens Robitussin Cough and Chest Congestion DM 5 mg/5mL; 100 mg/5mL 00031-8715-10 Haleon 1 bottle FDA listed
Robitussin Maximum Strength Cough Plus Chest Congestion Dm 20 mg/20mL; 400 mg/20mL 00031-8739-12 Haleon 1 bottle FDA listed
Robitussin Honey Maximum Strength Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-8756-12 Haleon 1 bottle FDA listed
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-0505-06 Walgreens 177 ml Discontinued
Cough and Chest Congestion DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-0506-06 Walgreens 177 ml FDA listed
tussin dm max 20 mg/20mL; 400 mg/20mL 00363-1144-26 Walgreen 1 bottle FDA listed
Mucus Relief Cough Childrens 5 mg/5mL; 100 mg/5mL 00363-5527-04 Walgreens 1 bottle FDA listed
Mucus Relief DM Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 00363-6005-06 WALGREENS 180 ml FDA listed
Walgreen Cough and Chest Congestion 20 mg/20mL; 400 mg/20mL 00363-7296-06 WALGREEN 180 ml FDA listed
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-7390-06 WALGREENS 180 ml FDA listed
Walgreens Daytime Childrens 5 mg/5mL; 100 mg/5mL 00363-7550-04 WALGREENS 118 ml FDA listed
Adult Cough plus Chest Congestion DM with Honey 20 mg/20mL; 400 mg/20mL 00363-7754-04 WALGREEN 1 bottle FDA listed
DM Max 20 mg/20mL; 400 mg/20mL 00363-8031-45 Walgreen 177 ml FDA listed
7 Select Maximum Strength 20 mg/20mL; 400 mg/20mL 10202-0740-04 7-ELEVEN 1 bottle FDA listed
up and up cough plus chest congestion 20 mg/20mL; 400 mg/20mL 11673-0627-26 Target 1 bottle Discontinued
tussin cough chest congestion 20 mg/20mL; 400 mg/20mL 11822-1332-01 Rite 1 bottle FDA listed
Mucus DM 20 mg/20mL; 400 mg/20mL 11822-5050-06 Rite 177 ml FDA listed
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 21130-0505-06 Safeway, 177 ml FDA listed
tussin 20 mg/20mL; 400 mg/20mL 21130-0707-26 Safeway 1 bottle FDA listed
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 30142-0508-06 The 177 ml FDA listed
tussin dm max 20 mg/20mL; 400 mg/20mL 30142-0843-26 Kroger 1 bottle FDA listed
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 36800-0605-06 TOP 177 ml FDA listed
topcare tussin dm max 20 mg/20mL; 400 mg/20mL 36800-0847-26 Topco 1 bottle FDA listed
Maximum Strength DM MAX 20 mg/20mL; 400 mg/20mL 37808-0518-25 H 177 ml FDA listed
Mucus Relief Cough Childrens 5 mg/5mL; 100 mg/5mL 37808-0594-04 H 1 bottle FDA listed
tussin 20 mg/20mL; 400 mg/20mL 37808-0639-26 H 1 bottle FDA listed
equaline tussin 20 mg/20mL; 400 mg/20mL 41163-0704-26 United 1 bottle FDA listed
KROGER Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 41226-0739-06 KROGER 180 ml FDA listed
adult dm max cough and chest congestion 20 mg/20mL; 400 mg/20mL 41250-0261-34 Meijer 1 bottle FDA listed
Meijer Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 41250-0748-06 MEIJER, 180 ml FDA listed
careone tussin dm 20 mg/20mL; 400 mg/20mL 41520-0931-26 American 1 bottle FDA listed
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL 42507-0630-58 Hyvee 177 ml FDA listed
Good Neighbor Pharmacy Mucus Relief Dm Maximum Strength 20 mg/20mL; 400 mg/20mL 46122-0840-29 AMERISOURCE 180 ml FDA listed
equate adult tussin dm max 20 mg/20mL; 400 mg/20mL 49035-0705-26 Wal-Mart 1 bottle FDA listed
Childrens Cough 5 mg/5mL; 100 mg/5mL 49035-0773-03 Wal-Mart 1 bottle FDA listed
Maximum Strength Mucus Relief DM 20 mg/20mL; 400 mg/20mL 49035-0839-06 Wal-Mart 180 ml FDA listed
Tussin DM Max 20 mg/20mL; 400 mg/20mL 49035-0930-19 Wal-Mart 1 bottle FDA listed
Tussin DM Daytime 20 mg/20mL; 400 mg/20mL 51316-0304-19 CVS 1 bottle FDA listed
Cough and Chest Congestion DM Daytime 20 mg/20mL; 400 mg/20mL 51316-0305-19 CVS 1 bottle FDA listed
DM Maximum 20 mg/20mL; 400 mg/20mL 51316-0310-45 CVS 177 ml FDA listed
Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 51316-0389-45 CVS 177 ml FDA listed
Cough and Congestion 20 mg/20mL; 400 mg/20mL 51316-0500-19 CVS 1 bottle FDA listed
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 51316-0552-03 CVS 1 bottle FDA listed
CVS Maximum Strength 20 mg/20mL; 400 mg/20mL 51316-0740-04 CVS 1 bottle FDA listed
CVS Adult Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 51316-0775-08 CVS 1 bottle FDA listed
daytime cough and chest congestion dm 20 mg/20mL; 400 mg/20mL 51316-0826-26 CVS 1 bottle FDA listed
Pediacare Childrens Cough and Congestion Grape 5 mg/5mL; 100 mg/5mL 52412-0992-01 RANDOB 1 bottle FDA listed
Maximum strength Tussnex FM DM Max 20 mg/20mL; 400 mg/20mL 53041-0628-58 Guardian 177 ml FDA listed
DM Max CONGESTION and COUGH 20 mg/20mL; 400 mg/20mL 53942-0518-25 DeMoulas 177 ml FDA listed
Childrens Cough Mucus Relief 5 mg/5mL; 100 mg/5mL 53943-0512-24 Discount 118 ml FDA listed
Maxium Strength Dm Max 20 mg/20mL; 400 mg/20mL 53943-0518-25 Discount 117 ml FDA listed
Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 55319-0731-45 Family 177 ml FDA listed
Maximum Strength Adult Cough plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 55319-0740-04 FAMILY 1 bottle FDA listed
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 55319-0924-03 Family 1 bottle FDA listed
SanaTos Children Cough and Congestion Cherry 100 mg/5mL; 5 mg/5mL 55758-0013-04 Pharmadel 1 bottle FDA listed
SanaTos Mucus Relief Cold Toddlers 50 mg/2.5mL; 2.5 mg/2.5mL 55758-0307-02 Pharmadel 59 ml FDA listed
Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 55910-0146-95 DOLGENCORP, 266 ml FDA listed
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 55910-0505-08 Dolgencorp, 266 ml FDA listed
rexall dm cough and congestion relief 20 mg/20mL; 400 mg/20mL 55910-0755-26 Dolgencorp, 1 bottle FDA listed
GeriCare Tussin DM Max 20 mg/20mL; 400 mg/20mLthis 57896-0591-08 GERI-CARE 237 ml FDA listed
Mucinex Fast-Max DM Max 20 mg/20mL; 400 mg/20mL 63824-0019-22 Reckitt 2 bottles Discontinued
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 63868-0235-06 QUALITY 177 ml FDA listed
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 63868-0771-04 Chain 1 bottle FDA listed
DM Max 20 mg/20mL; 400 mg/20mL 63941-0518-25 Best 177 ml FDA listed
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 67091-0342-06 WINCO 180 ml FDA listed
Premier Value Maximum Strength 20 mg/20mL; 400 mg/20mL 68016-0740-04 PHARMACY 1 bottle FDA listed
Mucus Relief DM Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 68163-0605-06 RARITAN 180 ml FDA listed
berkley and jensen tussin dm 20 mg/20mL; 400 mg/20mL 68391-0299-34 BJWC 1 bottle FDA listed
Berkley and Jensen Tussin DM Max 20 mg/20mL; 400 mg/20mL 68391-0711-34 BJWC 1 bottle FDA listed
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 69256-0505-06 Harris 177 ml FDA listed
Tussin DMMax 20 mg/20mL; 400 mg/20mL 69618-0072-58 RELIABLE 1 bottle FDA listed
Kids Cough and Chest Congestion 100 mg/5mL; 5 mg/5mL 69676-0037-09 Genexa 1 bottle FDA listed
CVS Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 69842-0577-04 CVS 1 bottle FDA listed
tussin dm 20 mg/20mL; 400 mg/20mL 69842-0819-26 CVS 1 bottle FDA listed
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 69842-0904-06 CVS 177 ml FDA listed
Cough and Chest Congestion DM Adult 20 mg/20mL; 400 mg/20mL 69842-0926-06 CVS 177 ml FDA listed
CVS Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 69842-0937-06 CVS 180 ml FDA listed
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 70000-0630-01 CARDINAL 1 bottle FDA listed
basic care tussin dm max 20 mg/20mL; 400 mg/20mL 72288-0293-34 Amazon.com 1 bottle FDA listed
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength 400 mg/1; 20 mg 72854-0159-66 Reckitt 180 liquids FDA listed
Dr Kids Cough and Chest Congestion 100 mg/5mL; 5 mg/5mL 73282-2523-02 CalmCo 18 vials FDA listed
Childrens Mucus Relief Cough Cherry Liquid 5 mg/5mL; 100 mg/5mL 76162-0294-04 Topco 1 bottle FDA listed
Maximum Strength Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 76162-0628-58 Topco 177 ml FDA listed
TOPCO Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 76162-0751-04 Topco 1 bottle FDA listed
Childrens Mucus Relief Cough - Cherry Flavor 5 mg/5mL; 100 mg/5mL 76281-0512-24 AptaPharma 1 bottle FDA listed
Target Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 82442-0751-04 TARGET 1 bottle FDA listed
Mucus Relief Cough and Congestion Childrens 5 mg/5mL; 100 mg/5mL 82673-0102-04 KinderFarms, 1 bottle FDA listed
AXIM DM Max 20 mg/20mL; 400 mg/20mL 82706-0013-01 VIVUNT 177 ml FDA listed
AXIV DM Max 20 mg/20mL; 400 mg/20mL 82706-0024-01 VIVUNT 177 ml FDA listed
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 83324-0323-06 Chain 177 ml FDA listed
Tussin DM 20 mg/20mL; 400 mg/20mL 83324-0324-04 Chain 1 bottle FDA listed
Dr. Simi Children s Cough 5 mg/5mL; 100 mg/5mL 85786-0604-04 Farmacias 1 bottle 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
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

🏛️
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.

🔬 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 GeriCare Tussin DM Max (this brand).

Top reported reactions

Dehydration1
Dry Skin1
Feeling Hot1
Hyperhidrosis1
Limb Discomfort1
Speech Disorder1
Tremor1

Reporter sex

1 reports
Male · 100%
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
57896-0591-08 You're viewing this 237 mL in 1 BOTTLE (57896-591-08) 2025-12-01 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 57896-591-08, 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: 57896-0591-08, written without dashes as 57896059108. 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 57896-0591-08, the first segment (57896) is the labeler code FDA assigned to GERI-CARE PHARMACEUTICALS, CORP; the middle segment (0591) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 GERI-CARE PHARMACEUTICALS, CORP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GERI-CARE PHARMACEUTICALS, CORP 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 24 words

Uses temporarily relieves cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive

⏱️ Dosage and Administration 51 words

Directions: do not use more than directed do not take more than 6 doses in 24 hours measure only with dosing cup provided keep dosing cup with product mL=mililiter Age Dose Adults and children over 12 years and over 20 mL every 4 hours Children under 12 years do not use

⚠️ Warnings 140 words

Warnings Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product. Do not use if you have 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 for more than 7 days, comes back, or is accompanied by fever, rash, or head that lasts. These could be signs of a serious condition.

🧪 Active Ingredient 12 words

In each 20 mL Dextromethorphan HBr- 20 mg Guaifenesin - 400 mg

🧪 Inactive Ingredients 26 words

Inactive ingredients artificial and natural flavor, citric acid, FD&C Blue #1, FD&C #40, hydroxyethyl cellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

🎯 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.