Adult Long Lasting Cough Relief Dextromethorphan HBr 15 mg Capsule, Liquid Filled, 15-count
by Shield Pharmaceuticals Corp · 1 BOTTLE in 1 CARTON (83059-0027-1) / 15 CAPSULE, LIQUID FILLED in 1 BOTTLE
NDC 83059-0027-01
🏷️ FDA NDC (as labeled)
83059-0027-1
billing pads the package segment with a zero
OTC
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
83059-0027-1
Product NDC
83059-0027
11-digit billing NDC
83059002701
RxCUI
1090487
UNII
9D2RTI9KYH
UPC
0611419406194
Application #
M012
SPL Set ID
8ef37bfa-ae80-4575-8394-f97ae95b4a01
Established class (EPC)
Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action
Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Aug 2026)
Marketing start
2024-04-08
Route
ORAL
Dosage form
CAPSULE, LIQUID FILLED
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs?
The FDA registers this code as 83059-0027-1 — 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 → 83059-0027-01. 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
LabelerShield Pharmaceuticals Corp
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code83059
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio103 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
📗 Our plain-language guide HelloPharmacist
- It won't necessarily silence your cough entirely, but it does temporarily suppress the cough reflex and reduce how intense and frequent your cough is. It can also help reduce that...
- What exactly does dextromethorphan do — will it stop my cough completely?
- It depends on your child's age and the specific product. Most dextromethorphan products should not be given to children under 4 years old without a doctor's guidance. Some products...
- This is a really important question. If your antidepressant is an MAOI (monoamine oxidase inhibitor), you absolutely cannot take dextromethorphan — not while you're on it, and not...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dextromethorphan HBr — 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.
💬 Questions about Dextromethorphan HBr?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 system | Per mL | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextromethorphan HBr 15 mg Liquid Gels 00536-1334-34 | RUGBY | 20 capsules | $0.117 | — | Availability likely | — |
| QUALITY CHOICE Long Acting Cough Softgel 15 mg 83324-0303-20 | Chain | 20 capsules | $0.117 | — | Availability likely | — |
| Robitussin Long-Acting Coughgels 15 mg 00031-8743-20 | Haleon | 20 capsules | — | — | FDA listed | — |
| Robitussin Direct Cough 15 mg 00031-9302-01 | Haleon | 18 capsules | — | — | FDA listed | — |
| Cough Relief 15 mg 00363-8990-20 | WALGREEN | 20 capsules | — | — | FDA listed | — |
| Cough Suppressant Adult 15 mg 00536-1480-34 | Rugby | 20 capsules | — | — | FDA listed | — |
| Dextromethorphan Hydrobromide 15 mg 35916-0461-01 | Softgel | 20 capsules | — | — | FDA listed | — |
| Long Acting Cough Softgels 15 mg 51316-0778-23 | CVS | 20 capsules | — | — | FDA listed | — |
| CVS Health COUGH SUPPRESSANT SOFTGEL 15 mg 51316-0877-23 | CVS | 20 capsules | — | — | FDA listed | — |
| Dextromethorphan HBr 15 mg 53345-0011-01 | Humanwell | 12000 capsules | — | — | FDA listed | — |
| Dextromethorphan HBr 15 mg 53345-0028-01 | Humanwell | 12000 capsules | — | — | FDA listed | — |
| Right Remedies Adult Long Lasting Cough Relief Softgel 15 mg 70692-0778-06 | Strive | 60 capsules | — | — | FDA listed | — |
| Gencare Long-Acting Cough Relief 15 mg 72090-0063-01 | PIONEER | 120 capsules | — | — | FDA listed | — |
| Dextromethorphan Hbr 15 Mg 73629-0005-10 | AMZ789 | 100 capsules | — | — | FDA listed | — |
| Cough Relief 15 mg 80513-0311-06 | Advanced | 60 capsules | — | — | FDA listed | — |
| ValuMeds Cough Relief, Dextromethorphan Hbr 15 mg 82725-1010-01 | Cabinet | 120 capsules | — | — | FDA listed | — |
| Goodmeds Non-Drowsy Cough Relief 15 mg 82725-4010-01 | Cabinet | 120 capsules | — | — | FDA listed | — |
| Goodmeds Cough Relief Dextromethorphan HBr 15 mg 82725-4110-01 | Cabinet | 120 capsules | — | — | FDA listed | — |
| Adult Long Lasting Cough Relief 15 mgthis 83059-0027-01 | Shield | 15 capsules | — | — | Discontinued | — |
| Adult Long Lasting Cough Relief 15 mg 83059-0110-08 | Shield | 15 capsules | — | — | Discontinued | — |
| Nuvicare Long-Acting Cough Relief 15 mg 84324-0037-01 | NUVICARE | 60 capsules | — | — | FDA listed | — |
| Adult Long Lasting Cough Relief 15 mg 83059-0170-01 | Shield | 15 capsules | — | — | FDA listed | — |
| Dextromethorphan HBr 15 mg 69452-0573-17 | BIONPHARMA | 60 capsules | — | — | 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
🏛️
2024
On the market since
Apr 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.
🔬 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 Adult Long Lasting Cough Relief (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 57%
Female · 43%
Unknown · 0%
Serious outcomes
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83059-0027-01 You're viewing this | 1 BOTTLE in 1 CARTON (83059-0027-1) / 15 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2024-04-08 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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) | — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 83059-0027-1, 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: 83059-0027-01, written without dashes as 83059002701. 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 83059-0027-01, the first segment (83059) is the labeler code FDA assigned to Shield Pharmaceuticals Corp; the middle segment (0027) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Shield 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
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
⏱️ Dosage and Administration ▾
Directions do not take more than 8 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over take 2 softgels every 6 to 8 hours, as needed children under 12 years do not use
⚠️ Warnings ▾
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 • a cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic as occurs with smoking, asthma, 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.
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).
🧪 Active Ingredient ▾
Active ingredient (in each softgel) Dextromethorphan HBr, USP 15 mg
🧪 Inactive Ingredients ▾
Inactive ingredients FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow 06, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitan
🎯 Purpose ▾
Purpose Cough suppressant
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 ↗
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.