QCH Adult Tussin DM 542 Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 200 mg/20mL Liquid — NDC 83324-023-08 (Billing 83324-0023-08)
by Chain Drug Marketing Association Inc. · 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE
This is a package of QCH Adult Tussin DM 542 Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 200 mg/20mL Liquid from Chain Drug Marketing Association Inc., marketed since May 2024 and currently FDA-listed; retail pharmacies pay about $0.0148 per mL (NADAC).
NDC 83324-0023-08
🏷️ FDA NDC (as labeled)
83324-023-08
billing pads the product segment with a zero
This package
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
83324-023-08
Product NDC
83324-023
11-digit billing NDC
83324002308
NCPDP billing unit
ML — per mL (volume)
RxCUI
1790650
UNII
9D2RTI9KYH, 495W7451VQ
Application #
part341
SPL Set ID
17caffa4-a264-7f3e-e063-6394a90ac419
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
2024-05-08
Route
ORAL
Dosage form
LIQUID
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
079414
GCN
45903
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
QC TUSSIN DM 200-20 MG/20 ML
FDB brand name
Tussin Dm
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 079414
- GCN: 45903
- HICL (First Databank): 000223
- AHFS class code: 48:08.00.00
- RxCUI (RxNorm): 1790650
Why two NDCs?
The FDA registers this code as 83324-023-08 — 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 → 83324-0023-08. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name QC TUSSIN DM 200-20 MG/20 ML Ingredient Guaifenesin/Dextromethorphan
📗 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dextromethorphan HBr, Guaifenesin — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Dextromethorphan HBr, Guaifenesin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.015 | $3.51 / 237 ml |
| 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. | |
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 2% over the last 10 months.
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.
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 83324-0023-04 83324-023-04 Main listing | 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | $0.0207 / mL | $2.44 | 2024-05-08 | — | Active |
| 83324-0023-08 You're viewing this | 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE | $0.0148 / mL | $3.50 | 2024-05-08 | — | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0148 NADAC).
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 237 ml in 1 bottle.
What NDC number is used to bill for this package of QCH Adult Tussin DM 542 Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 200 mg/20mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. 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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion 20 mg/20mL; 200 mg/20mL 46122-0783-34 | AMERISOURCE | 1 bottle | $0.015 | — | Availability likely | — |
| QCH Adult Tussin DM 542 20 mg/20mL; 200 mg/20mLthis 83324-0023-08 | Chain | 1 bottle | $0.015 | — | Availability likely | — |
| rugby cough syrup 20 mg/20mL; 200 mg/20mL 00536-1348-97 | Rugby | 1 bottle | $0.017 | — | Availability likely | +14% |
| Tussin DM 200 mg/20mL; 20 mg/20mL 70677-1185-01 | Strategic | 1 bottle | $0.020 | — | Availability likely | +37% |
| good sense tussin dm 20 mg/20mL; 200 mg/20mL 00113-1725-26 | L. | 1 bottle | $0.021 | — | Availability likely | +40% |
| robafen dm 20 mg/20mL; 200 mg/20mL 00904-7223-20 | Major | 1 bottle | $0.021 | — | Availability likely | +40% |
| Robafen DM Cough 20 mg/20mL; 200 mg/20mL 00904-7441-20 | Major | 1 bottle | $0.021 | — | Availability likely | +40% |
| good neighbor pharmacy adult tussin DM 20 mg/20mL; 200 mg/20mL 46122-0704-26 | Amerisource | 1 bottle | $0.021 | — | Availability likely | +40% |
| Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion 20 mg/20mL; 200 mg/20mL 46122-0782-29 | AMERISOURCE | 1 bottle | $0.021 | — | Availability likely | +40% |
| Tussin DM 20 mg/20mL; 200 mg/20mL 70000-0670-01 | Cardinal | 1 bottle | $0.021 | — | Availability likely | +40% |
| foster and thrive adult tussin dm 20 mg/20mL; 200 mg/20mL 70677-1035-01 | Strategic | 1 bottle | $0.021 | — | Availability likely | +40% |
| Tussin DM 20 mg/20mL; 200 mg/20mL 70677-1261-01 | Strategic | 1 bottle | $0.021 | — | Availability likely | +40% |
| QCH Adult Tussin DM Sugar free 545 20 mg/20mL; 200 mg/20mL 83324-0025-04 | Chain | 1 bottle | $0.021 | — | Availability likely | +40% |
| Childrens Robitussin Cough and Chest Congestion DM 20 mg/20mL; 200 mg/20mL 00031-8702-13 | Haleon | 1 bottle | — | — | FDA listed | — |
| Robitussin Cough Plus Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 00031-8757-12 | Haleon | 1 bottle | — | — | FDA listed | — |
| Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM 20 mg/20mL; 200 mg/20mL 00031-8759-12 | Haleon | 1 bottle | — | — | FDA listed | — |
| Childrens Robitussin Honey Cough and Chest Congestion DM 10 mg/10mL; 100 mg/10mL 00031-8760-12 | Haleon | 1 bottle | — | — | FDA listed | — |
| adult tussin dm 20 mg/20mL; 200 mg/20mL 00363-1603-26 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Walgreen Adult Cough Plus Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 00363-7440-08 | WALGREEN | 1 bottle | — | — | FDA listed | — |
| Walgreens Grape Flavor 20 mg/20mL; 200 mg/20mL 00363-7470-04 | WALGREENS | 1 bottle | — | — | FDA listed | — |
| tussin cough and chest congestion 20 mg/20mL; 200 mg/20mL 11822-1630-00 | Rite | 1 bottle | — | — | FDA listed | — |
| equaline adult tussin 20 mg/20mL; 200 mg/20mL 41163-0813-26 | United | 1 bottle | — | — | FDA listed | — |
| Robafen Dm 20 mg/20mL; 200 mg/20mL 50090-6747-00 | A-S | 1 bottle | — | — | FDA listed | — |
| good sense tussin dm 20 mg/20mL; 200 mg/20mL 50090-7257-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Cough And Chest Congestion 20 mg/20mL; 200 mg/20mL 51316-0082-34 | CVS | 1 bottle | — | — | FDA listed | — |
| Cough And Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 51316-0473-34 | CVS | 1 bottle | — | — | FDA listed | — |
| Cvs Adult Cough Plus Chest Congestion Dm 20 mg/20mL; 200 mg/20mL 51316-0744-08 | CVS | 1 bottle | — | — | FDA listed | — |
| dg health adult tussin 20 mg/20mL; 200 mg/20mL 55910-0776-26 | Dolgencorp | 1 bottle | — | — | FDA listed | — |
| adult tussin dm 20 mg/20mL; 200 mg/20mL 56062-0607-26 | Publix | 1 bottle | — | — | FDA listed | — |
| tussin 20 mg/20mL; 200 mg/20mL 59640-0100-26 | H | 1 bottle | — | — | FDA listed | — |
| Premier Value 20 mg/20mL; 200 mg/20mL 68016-0744-04 | PHARMACY | 1 bottle | — | — | FDA listed | — |
| DRx Choice Children daytime Cough and Chest Congestion 20 mg/20mL; 200 mg/20mL 68163-0747-04 | RARITAN | 1 bottle | — | — | FDA listed | — |
| robafen dm 20 mg/20mL; 200 mg/20mL 68788-8268-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| good sense tussin dm 20 mg/20mL; 200 mg/20mL 68788-8300-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| rugby cough syrup 20 mg/20mL; 200 mg/20mL 68788-8303-01 | Preferred | 1 bottle | — | — | FDA listed | — |
| adult tussin dm 20 mg/20mL; 200 mg/20mL 69842-0513-26 | CVS | 1 bottle | — | — | FDA listed | — |
| leader tussin dm 20 mg/20mL; 200 mg/20mL 70000-0596-01 | Cardinal | 1 bottle | — | — | FDA listed | — |
| Tussin DM Cough plus Chest Congestion 20 mg/20mL; 200 mg/20mL 70000-0713-01 | Cardinal | 1 bottle | — | — | FDA listed | — |
| basic care tussin dm 20 mg/20mL; 200 mg/20mL 72288-0631-26 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| careone tussin dm 20 mg/20mL; 200 mg/20mL 72476-0630-26 | Retail | 1 bottle | — | — | FDA listed | — |
| topcare tussin dm 20 mg/20mL; 200 mg/20mL 76162-0600-26 | Topco | 1 bottle | — | — | FDA listed | — |
| adult cough and chest congestion 20 mg/20mL; 200 mg/20mL 79481-0063-00 | Meijer, | 1 bottle | — | — | FDA listed | — |
| Meijer Children Cough and Chest Congestion DM Grape Flavor 20 mg/20mL; 200 mg/20mL 79481-7470-08 | MEIJER | 1 bottle | — | — | FDA listed | — |
| equate adult cough and chest congestion dm 20 mg/20mL; 200 mg/20mL 79903-0095-08 | WALMART | 1 bottle | — | — | FDA listed | — |
| Tussin DM 20 mg/20mL; 200 mg/20mL 83324-0327-04 | Chain | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.
- FDA Orange Book · refreshed Sep 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerChain Drug Marketing Association Inc.
FDA applicationpart341 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio72 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Other Information
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
USE(S) temporarily relieves cough due too 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 ▾
DIRECTIONS shake well before using do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product ml=milliliter this adult product is not intended for use in children under 12 years of age Age Dose adults & children 12 years & over 20 mL every 4 hours children under 12 years do not use
⚠️ Warnings ▾
WARNINGS .
🧪 Active Ingredient ▾
ACTIVE INGREDIENT(S) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS carboxymethylcellulose sodium, citric acid, FD&C blue 1 dye, FD&C red 40 dye, flavor, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.
🎯 Purpose ▾
PURPOSE Cough suppressant Expectorant
📄 Do Not Use ▾
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 ▾
ASK A DOCTOR BEFORE USE IF 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 ▾
STOP USE AND ASK DOCTOR IF 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 ▾
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Other Information ▾
OTHER INFORMATION each 20 mL contains: sodium 15 mg store at 20-25 o C (68-77 o F) do not refrigerate
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 83324-023-04 QUALITY CHOICE *Compare to the Active Ingredients in Robitussin ® DM Adult Tussin DM Cough Suppressant/ Expectorant Dextromethorphan HBr 20 mg per 20 mL Guaifenesin 200 mg per 20 mL For Ages 12 & over Helps Control Cough Relieves Chest Congestion Thins and Loosens Mucus Non- Drowsy Raspberry Flavor 4 FL OZ(118 mL) NDC 83324-023-08 QUALITY CHOICE *Compare to the Active Ingredients in Robitussin ® DM Adult Tussin DM Cough Suppressant/ Expectorant Dextromethorphan HBr 20 mg per 20 mL Guaifenesin 200 mg per 20 mL For Ages 12 & over Helps Control Cough Relieves Chest Congestion Thins and Loosens Mucus Non- Drowsy Raspberry Flavor 8 FL OZ(237 mL) 542-qch-label.jpg 542-qch-carton.jpg 542-qch-8-carton.jpg 542-qch-8-label.jpg
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 | — Not published for this NDC No photo available yet for this listing. |
| 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) | ✓ Available |
| 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.
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 Chain Drug Marketing Association 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 1 other package presentation of this same product, including 1 bottle (83324-0023-04). 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?
Chain Drug Marketing Association 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.
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.