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Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled, 1,000-count — NDC 35916-0461-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled, 1,000-count — NDC 35916-0461-2 (Billing 35916-0461-02)

by Softgel Healthcare Pvt Ltd · 1000 CAPSULE, LIQUID FILLED in 1 BAG

This is a package of 1,000 capsules of Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled from Softgel Healthcare Pvt Ltd, marketed since Sep 2024 and currently FDA-listed.

NDC 35916-0461-02
🏷️ FDA NDC (as labeled) 35916-0461-2 billing pads the package segment with a zero
This package
Contains1,000-count Pack sizes4 compare ↓
Product page 35916-0461-01 Also comes in: 20 capsules 35916-0461-1 1500 capsules 35916-0461-4 3000 capsules 35916-0461-3
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) 35916-0461-2
Product NDC 35916-0461
11-digit billing NDC 35916046102
RxCUI 1090487
UNII 9D2RTI9KYH
Application # M012
SPL Set ID 20f7c1a9-fc4d-1f51-e063-6394a90a8be3
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 On market
FDA listing status Listed (active directory)
Marketing start 2024-09-11
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1090487
Why two NDCs? The FDA registers this code as 35916-0461-2 — 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 → 35916-0461-02. 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's a cough suppressant. It temporarily relieves cough from minor throat and bronchial irritation, like with a cold or inhaled irritants. Some products also help you sleep by calm...
  • It depends on the product. Extended-release suspensions like Delsym are labeled for every 12 hours, while Giltuss Honey DM Cough is every 6 to 8 hours with a 4-dose daily limit. Ch...
  • Be careful. Don't use it if you take a prescription MAOI, or within 2 weeks of stopping one. If you're not sure whether your medicine is an MAOI, ask me or your doctor before takin...
  • Nighttime products can cause marked drowsiness, and children may become excitable. Avoid alcohol and be careful driving.
📖 Read our full Dextromethorphan 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: 20 capsules 1500 capsules 3000 capsules
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
35916-0461-01 35916-0461-1 Main listing 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 2024-09-11 — Active
35916-0461-02 You're viewing this 1000 CAPSULE, LIQUID FILLED in 1 BAG 2025-03-18 — Active
35916-0461-03 35916-0461-3 2 POUCH in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2025-07-17 — Active
35916-0461-04 35916-0461-4 2 BAG in 1 BOX / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2026-01-12 — Active

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 capsule, liquid filled in 1 bag.
How does this package differ from NDC 35916-0461-01?
Both are Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 1,000-count one, while NDC 35916-0461-01 is the 20 capsules package.
What NDC number is used to bill for this package of Dextromethorphan Hydrobromide 15 mg Capsule, Liquid Filled?
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
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 mgthis 35916-0461-02 Softgel 1000 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 mg 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 —
QUALITY CHOICE Adult Long-Acting Cough Softgel 15 mg 83324-0346-20 Chain 20 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
Sep 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.

What it looks like

Color red
ShapeOval
Size13 mm
ScoringNot scored
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.

Manufacturer & labeler

LabelerSoftgel Healthcare Pvt Ltd
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code35916
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio15 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
🎯 Indications and Usage 17 words ▾

Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

⏱️ Dosage and Administration 53 words ▾

Directions do not take more than 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use

⚠️ Warnings 1 words ▾

Warnings

🧪 Active Ingredient 12 words ▾

Active ingredient (in each soft gelatin capsule) Dextromethorphan HBr, USP 15 mg

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, purified water, sorbital sorbitan solution

🎯 Purpose 3 words ▾

Purpose Cough suppressant

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 ✓ 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 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 Softgel Healthcare Pvt Ltd. 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 3 other package presentations of this same product, including 20 capsules (35916-0461-01), 1500 capsules (35916-0461-04), 3000 capsules (35916-0461-03). 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?
Softgel Healthcare Pvt Ltd 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.
← 35916-0454-01 · SOFTGEL 35916-0470-01 · Softgel →
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.