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Tussin DM Sugar free Dextromethorphan HBr and Guaifenesin 20 mg/10mL; 200 mg/10mL Liquid — NDC 82568-0015-08 package photo

Tussin DM Sugar free Dextromethorphan HBr and Guaifenesin 20 mg/10mL; 200 mg/10mL Liquid

by AARNA USA, Inc. · 1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-8) / 236 mL in 1 BOTTLE, PLASTIC
NDC 82568-0015-08
🏷️ FDA NDC (as labeled) 82568-0015-8 billing pads the package segment with a zero
This package
Contains236 mL in 1 bottle, plastic Pack sizes3 compare ↓
Also comes in: 118 mL 82568-0015-04 473 ml 82568-0015-06
OTC On market Non-controlled
🗂️ Data synced Sep 10, 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

🆔 Identity & classification

FDA NDC (as labeled) 82568-0015-8
Product NDC 82568-0015
11-digit billing NDC 82568001508
NCPDP billing unit ML — per mL (volume)
RxCUI 996520
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 3a521b65-fb35-4cc3-b826-88513afda0f9
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 2025-02-18
Route ORAL
Dosage form LIQUID
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 TUSSIN DM 20-200 MG/10 ML LIQ
FDB brand name Tussin Dm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 82568-0015-8 — a 5-4-1 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 package segment → 82568-0015-08. 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

LabelerAARNA USA, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code82568
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio3 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 20-200 MG/10 ML LIQ 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 →

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.

💊 What it looks like

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 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.
Try another pack size: 118 mL 473 ml
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 —
Tusnel Diabetic 10 mg/5mL; 100 mg/5mL 54859-0505-04 LLORENS 118 ml $0.011 — Availability likely —
Mucolyte DM 100 mg/5mL; 10 mg/5mL 57237-0360-12 Rising 118 ml $0.011 — Availability likely —
Tussin DM Regular 20 mg/10mL; 200 mg/10mL 82568-0014-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Cough and Chest Congestion Non Drowsy 20 mg/10mL; 200 mg/10mL 63868-0868-54 QUALITY 1 bottle $0.018 — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0504-08 Method 237 ml $0.023 — Availability likely —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0505-08 Method 237 ml $0.023 — Availability likely —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 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 —
Tussin DM Sugar free 20 mg/10mL; 200 mg/10mLthis 82568-0015-08 AARNA 1 bottle — — 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

🏛️
2025
On the market since
Feb 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
82568-0015-04 1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-4) / 118 mL in 1 BOTTLE, PLASTIC $0.0111 / mL $1.31 2025-02-18 Active
82568-0015-06 473 mL in 1 BOTTLE, PLASTIC (82568-0015-6) — — 2025-02-18 Active
82568-0015-08 You're viewing this 1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-8) / 236 mL in 1 BOTTLE, PLASTIC — — 2025-02-18 Active

Pack size FAQ

What quantity is in NDC 82568-0015-08?
NDC 82568-0015-08 is listed by the FDA — 1 bottle, plastic in 1 package / 236 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Tussin DM Sugar free Dextromethorphan HBr and Guaifenesin 20 mg/10mL; 200 mg/10mL Liquid?
Bill NDC 82568-0015-08 — the 11-digit billing format is 82568001508. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 82568-0015-8, 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: 82568-0015-08, written without dashes as 82568001508. 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 82568-0015-08, the first segment (82568) is the labeler code FDA assigned to AARNA USA, Inc.; the middle segment (0015) 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 AARNA USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (82568-0015-04), 473 ml (82568-0015-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
AARNA USA, Inc. 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 29 words ▾

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

⏱️ Dosage and Administration 50 words ▾

Directions do not take more than 6 doses in any 24-hour period mL= milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

⚠️ Warnings 152 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. tt you do not know tt 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 persistent headache.

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

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

📦 Storage and Handling 15 words ▾

Other information Each 10 mL contains: Sodium 11.2 mg store between 20º-25ºC(68º-77ºF). Do not refrigerate.

🧪 Active Ingredient 15 words ▾

Active ingredient (in each 10 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

🎯 Purpose 5 words ▾

Purposes Cough suppressant and Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82568-0014-04 · AARNA 82568-0016-04 · AARNA →
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.