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topcare tussin dm dextromethorphan hydrobromide, guaifenesin 20 mg/20mL; 200 mg/20mL Solution — NDC 76162-600-34 (Billing 76162-0600-34)

by Topco Associates LLC · 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE

This is a package of topcare tussin dm dextromethorphan hydrobromide, guaifenesin 20 mg/20mL; 200 mg/20mL Solution from Topco Associates LLC, marketed since May 2022 and currently FDA-listed.

NDC 76162-0600-34
🏷️ FDA NDC (as labeled) 76162-600-34 billing pads the product segment with a zero
This package
Contains237 mL in 1 bottle Pack sizes2 compare ↓
Product page 76162-0600-26 Also comes in: 118 mL 76162-600-26
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76162-600-34
Product NDC 76162-600
11-digit billing NDC 76162060034
RxCUI 1790650
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID d3cae69e-41a5-4099-a3f4-ce25fd94df73
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 2022-05-11
Route ORAL
Dosage form SOLUTION
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 1790650
Why two NDCs? The FDA registers this code as 76162-600-34 — 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 → 76162-0600-34. 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

📗 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 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
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
76162-0600-26 76162-600-26 Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2022-05-11 — Active
76162-0600-34 You're viewing this 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE 2022-05-20 — Active

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 topcare tussin dm dextromethorphan hydrobromide, guaifenesin 20 mg/20mL; 200 mg/20mL Solution?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 —
rugby cough syrup 20 mg/20mL; 200 mg/20mL 00536-1348-97 Rugby 1 bottle $0.017 — Availability likely —
Tussin DM 200 mg/20mL; 20 mg/20mL 70677-1185-01 Strategic 1 bottle $0.020 — Availability likely —
good sense tussin dm 20 mg/20mL; 200 mg/20mL 00113-1725-26 L. 1 bottle $0.021 — Availability likely —
robafen dm 20 mg/20mL; 200 mg/20mL 00904-7223-20 Major 1 bottle $0.021 — Availability likely —
Robafen DM Cough 20 mg/20mL; 200 mg/20mL 00904-7441-20 Major 1 bottle $0.021 — Availability likely —
good neighbor pharmacy adult tussin DM 20 mg/20mL; 200 mg/20mL 46122-0704-26 Amerisource 1 bottle $0.021 — Availability likely —
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 —
Tussin DM 20 mg/20mL; 200 mg/20mL 70000-0670-01 Cardinal 1 bottle $0.021 — Availability likely —
foster and thrive adult tussin dm 20 mg/20mL; 200 mg/20mL 70677-1035-01 Strategic 1 bottle $0.021 — Availability likely —
Tussin DM 20 mg/20mL; 200 mg/20mL 70677-1261-01 Strategic 1 bottle $0.021 — Availability likely —
QCH Adult Tussin DM 542 20 mg/20mL; 200 mg/20mL 83324-0023-04 Chain 1 bottle $0.021 — Availability likely —
QCH Adult Tussin DM Sugar free 545 20 mg/20mL; 200 mg/20mL 83324-0025-04 Chain 1 bottle $0.021 — Availability likely —
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/20mLthis 76162-0600-34 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 —
Tussin 20 mg/20mL; 200 mg/20mL 21130-0454-34 Safeway 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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.

What it looks like

Color Red
FlavorFruit
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesanhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

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

LabelerTopco Associates LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code76162
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio408 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 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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

⏱️ Dosage and Administration 67 words ▾

Directions • 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 and children 12 years and over 20 mL every 4 hours children under 12 years do not use

⚠️ Warnings 158 words ▾

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

A persistent cough may be a sign 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).

🧪 Active Ingredient 15 words ▾

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

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

🎯 Purpose 4 words ▾

Purposes Cough suppressant Expectorant

📄 Do Not Use 55 words ▾

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 34 words ▾

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 36 words ▾

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

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).

📄 Other Information 18 words ▾

Other information • each 20 mL contains: sodium 14 mg • store at 20-25°C (68-77°F). Do not refrigerate.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 59 words ▾

Package/Label Principal Display Panel TopCare ® health COMPARE TO ROBITUSSIN ® COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS PEAK COLD SEE NEW DOSING NON-DROWSY Tussin DM Cough & Chest Congestion COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr EXPECTORANT – GUAIFENESIN RELIEVES: • Cough • Mucus Adult For Ages 12 & Over 4 FL OZ (118 mL) RASPBERRY FLAVOR tussin dm image

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 topcare tussin dm (this brand).

Top reported reactions

Blister1
Clonus1
Dermatitis1
Diarrhoea1
Drug Abuse1
Erythema1
Fixed Eruption1

Age at onset

Adult1

Reporter sex

5 reports
Male · 75%
Female · 25%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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 — Not published for this NDC No photo available yet for this listing.
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 Topco Associates LLC. 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 (76162-0600-26). 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?
Topco Associates 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.
← 76162-0599-40 · Topco 76162-0601-28 · Topco →
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.