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Aquanaz Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride 15 mg; 400 mg; 10 mg Tablet, 100-count — NDC 29978-0587-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aquanaz Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride 15 mg; 400 mg; 10 mg Tablet, 100-count — NDC 29978-587-01 (Billing 29978-0587-01)

by Capital Pharmaceutical, LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Aquanaz Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride 15 mg; 400 mg; 10 mg Tablet from Capital Pharmaceutical, LLC, marketed since Mar 2015 and currently FDA-listed. It is this product's only package size.

NDC 29978-0587-01
🏷️ FDA NDC (as labeled) 29978-587-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 29978-587-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
29978 labeler · 587 product · 01 package
Package marketed since
Mar 10, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0729978587015
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 29978-587-01
Product NDC 29978-587
11-digit billing NDC 29978058701
NCPDP billing unit EA — each (per item)
RxCUI 1552200
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0729978587015
SPL Set ID 5e9e4dfd-4def-4756-9bba-d25068640101
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-03-10
Route ORAL
Dosage form TABLET
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43997303100314
GPI class Aquanaz
GCN Seq No 072784
GCN 37072
HICL code 000216
Ingredient (HICL) Guaifen/Dextromethorphan/Pe
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4R
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-Decongestant-Expectorant
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name AQUANAZ TABLET
FDB brand name Aquanaz
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 072784
  • GCN: 37072
  • GPI-14 (Medi-Span): 43997303100314
  • HICL (First Databank): 000216
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1552200
Why two NDCs? The FDA registers this code as 29978-587-01 — 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 → 29978-0587-01. 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.

Clinical

Label name AQUANAZ TABLET Ingredient Guaifen/Dextromethorphan/Pe
🧪 What is this product?

Aquanaz is an oral tablet containing three active ingredients commonly used in over-the-counter cold and cough products. Dextromethorphan is typically used to suppress cough, while guaifenesin functions as an expectorant to help thin mucus secretions. Phenylephrine hydrochloride is a decongestant commonly used to help relieve nasal congestion. This product is marketed without an approved FDA application.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
29978-0587-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2015-03-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aquanaz 15 mg/1; 400 mg/1; 10 mgthis 29978-0587-01 Capital 100 tablets — — 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

🏛️
2015
On the market since
Mar 2015
📍
2026
Currently FDA-listed
11 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.

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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesF&C Blue #2 Microcrystalline Celulose, Silicone Dioxide, Stearic Acid.

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

LabelerCapital Pharmaceutical, LLC
Labeler code29978
First marketedMar 2015
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Capital Pharmaceutical, LLC labeler code 29978

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 📄 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 30 words ▾

Uses: Temporally relieves these symptoms accruing with a cold nasal decongestion cough due to minor throat and bronchial irritation—helps loosen phlegm (mucus) and thins bronchial secretions to drain bronchial tubes.

⏱️ Dosage and Administration 53 words ▾

Directions: Adults and children 12 years and older: Take 1tablet every 4-6 hours as needed, do not exceed 4 tablets in 24hours, or as directed by a doctor. Children 6-12 years: Take ½ tablet every 4-6 hours as needed, do not exceed 2 tablets in 24 hours, or as directed by a doctor.

⚠️ Warnings 61 words ▾

Warnings: When using this product do not exceed recommended dose. 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 MAOI drugs. If you do not know if your prescription drug contains an MAOI. Consult a doctor or pharmacist before taking this product.

🧪 Active Ingredient 14 words ▾

Active Ingredient. Dextromethorphan HBr 15mg.

Active Ingredient. Guaifenesin 400mg.

Active Ingredient. Phenylephrine HCL 10mg.

🧪 Inactive Ingredients 11 words ▾

Inactive Ingredients: F&C Blue #2 Microcrystalline Celulose, Silicone Dioxide, Stearic Acid.

🎯 Purpose 8 words ▾

Purpose. Cough Suppressant.

Purpose. Expectorant.

Purpose. Nasal Decongestant.

📄 Ask a Doctor Before Use If 44 words ▾

Ask a doctor before use if you have: Heart disease--high blood pressure--thyroid disease—diabetes--difficulty in urination due to enlargement of the prostate gland—persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompanied by excessive phlegm (mucus)

📄 Stop Use and Ask a Doctor If 62 words ▾

Stop use and ask a doctor if: Symptoms do not improve--new symptoms occur--redness or swelling is present--nervousness, dizziness or sleeplessness occurs--symptoms do not improve within 7 days or are accompanied by fever--cough persists for more than 1 week, tends to recur, or is a accompanied by fever, rash or persistent headache. A persistent cough may be the sign of a serious condition.

🤰 If Pregnant or Breast-Feeding 12 words ▾

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

📄 Keep Out of Reach of Children 43 words ▾

KEEP OUT OF REACH OF CHILDREN . In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

📄 Other Information 17 words ▾

Other Information: Do not use if there are signs of tampering—Store at controlled room temperature 15deg-30degC (59-86degF)

📄 Package Label / Principal Display Panel 59 words ▾

PRINCIPAL DISPLAY PANEL NDC 29978-587-01 NEW Aquanaz TABLETS TRIPLE COMBINATION RELIEF: Cough Suppressant : Dextromethorphan HB R 15 MG Expectorant : Guaifen e sin 400 MG Decongestant : Phenylephrine HCL 10 MG 100 Tablets PRINCIPAL DISPLAY PANEL NDC 29978-587-01 NEW Aquanaz TABLETS TRIPLE COMBINATION RELIEF: Cough Suppressant: Dextromethorphan HBR 15 MG Expectorant: Guaifenesin 400 MG Decongestant: Phenylephrine HCL 10

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 Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Covid-19132
Disease Recurrence108
Nausea90
Dizziness79
Nasopharyngitis79
Diarrhoea70
Fatigue63

Age at onset

Child4
Adolescent5
Adult123
Elderly46

Reporter sex

1,068 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization136
Death21
Life-threatening18
Disabling14
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 151 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 Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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) ✓ 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 "Unapproved Drug Other". 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 Capital Pharmaceutical, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Capital Pharmaceutical, 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.
← 29978-0129-10 · Capital 29978-0601-30 · Capital →
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.