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Altituss Dextromethorphan HBr, Guaifenesin 15 mg/7.5mL; 150 mg/7.5mL Liquid, 473 mL — NDC 53163-0113-16 package photo

Altituss Dextromethorphan HBr, Guaifenesin 15 mg/7.5mL; 150 mg/7.5mL Liquid, 473 mL

by Alternative Pharmacal Corporation · 473 mL in 1 BOTTLE (53163-113-16)
NDC 53163-0113-16
🏷️ FDA NDC (as labeled) 53163-113-16 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 53163-113-16
Product NDC 53163-113
11-digit billing NDC 53163011316
NCPDP billing unit ML — per mL (volume)
RxCUI 996520
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44
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 2015-03-01
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
GPI-14 43997002520910
GCN Seq No 000652
GCN 53491
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 ALTITUSS 15-150 MG/7.5 ML LIQ
FDB brand name Altituss
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 53163-113-16 — 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 → 53163-0113-16. 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

LabelerAlternative Pharmacal Corporation
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code53163
First marketedMar 2015
Product typeHuman Otc Drug
Portfolio3 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

Label name ALTITUSS 15-150 MG/7.5 ML LIQ Ingredient Guaifenesin/Dextromethorphan
📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The two ingredients tackle your symptoms from different angles. Guaifenesin is an expectorant — it helps thin and loosen the mucus in your chest so you can cough it up more easily....
  • What exactly does this combination do — why are two ingredients needed?
  • It depends on which antidepressant you're taking. If it's a type called an MAOI — which includes certain older antidepressants and some medications for Parkinson's disease — you sh...
  • Can I take this if I'm on an antidepressant?
📖 Read our full Dextromethorphan / Guaifenesin guide →
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.

🧪 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 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.

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

The official label also statesInactive ingredients Artificial and Natural flavor, Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

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.

💲 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.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chest Congestion Relief DM 10 mg/5mL; 100 mg/5mL 00536-1313-85 RUGBY 473 ml $0.009 — Availability likely —
Tusnel Diabetic 10 mg/5mL; 100 mg/5mL 54859-0505-04 LLORENS 118 ml $0.011 — Availability likely —
Mucolyte DM 100 mg/5mL; 10 mg/5mL 57237-0360-12 Rising 118 ml $0.011 — Availability likely —
Tussin DM Regular 20 mg/10mL; 200 mg/10mL 82568-0014-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Sugar free 20 mg/10mL; 200 mg/10mL 82568-0015-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Cough and Chest Congestion Non Drowsy 20 mg/10mL; 200 mg/10mL 63868-0868-54 QUALITY 1 bottle $0.018 — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0504-08 Method 237 ml $0.023 — Availability likely —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0505-08 Method 237 ml $0.023 — Availability likely —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 57237-0312-51 Rising 100 cups $0.405 — Availability likely —
Dextromethorphan HBr and Guaifenesin Oral Solution 100 mg/5mL; 10 mg/5mL 81033-0103-50 KESIN 100 cups $0.405 — Availability likely —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 00121-0638-00 PAI 10 cups — — FDA listed —
Guaifenesin Dm 200 mg/10mL; 20 mg/10mL 00121-1276-00 PAI 10 cups — — FDA listed —
Guaifenesin and Dextromethorphan 100 mg/5mL; 10 mg/5mL 00904-7512-70 Major 10 cups — — FDA listed —
Guaifenesin and Dextromethorphan 200 mg/10mL; 20 mg/10mL 00904-7513-72 Major 10 cups — — FDA listed —
Carolina Crud Crusher 200 mg/10mL; 20 mg/10mL 11383-0311-08 Weeks 236 ml — — FDA listed —
Target Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 11673-0775-08 TARGET 1 bottle — — FDA listed —
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 17856-1126-01 ATLANTIC 72 cups — — FDA listed —
Adult Cough and Chest Congestion Relief DM Non Drowsy 20 mg/10mL; 200 mg/10mL 21130-0385-04 Safeway, 1 bottle — — FDA listed —
Tussin DM Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 21130-0583-04 Safeway, 1 bottle — — FDA listed —
Tussin Cough Sugar Free 20 mg/10mL; 200 mg/10mL 49580-0834-04 P 1 bottle — — FDA listed —
Tukol Sugar Free Cough and Cold 2 mg/mL; 20 mg/mL 50066-0505-04 Genomma 1 bottle — — FDA listed —
Sorbugen 15 mg/7.5mL; 150 mg/7.5mL 52083-0660-16 Kramer 480 ml — — FDA listed —
Defensol Adult Syrup 200 mg/10mL; 20 mg/10mL 53145-0039-04 Menper 1 bottle — — FDA listed —
Cosedal Drops 10 mg/5mL; 100 mg/5mL 53145-0059-02 Menper 1 bottle — — FDA listed —
Adult Bisolvine Adult 20 mg/10mL; 200 mg/10mL 53145-0323-04 MENPER 120 ml — — FDA listed —
Altituss 15 mg/7.5mL; 150 mg/7.5mLthis 53163-0113-16 Alternative 473 ml — — FDA listed —
Tussin DM Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 53942-0503-26 DeMoulas 237 ml — — FDA listed —
Tussin DM 10 mg/5mL; 100 mg/5mL 53943-0503-26 Discount 237 ml — — FDA listed —
Limpia Pecho 10 mg/5mL; 100 mg/5mL 54859-0011-04 Llorens 118 ml — — FDA listed —
Tusnel SF 10 mg/5mL; 100 mg/5mL 54859-0506-04 Llorens 118 ml — — FDA listed —
Tusnel Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 54859-0509-16 Llorens 473 ml — — FDA listed —
Llorens Care Tussin DM 10 mg/5mL; 100 mg/5mL 54859-0833-04 Llorens 118 ml — — FDA listed —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5783-05 Cardinal 5 cups — — FDA listed —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5785-05 Cardinal 5 cups — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 57237-0313-18 Rising 80 cups — — FDA listed —
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 57243-0503-24 Salado 118 ml — — FDA listed —
Geri-Tussin DM 20 mg/10mL; 200 mg/10mL 57896-0291-16 Geri-Care 473 ml — — FDA listed —
Geri-Tussin DM 10 mg/5mL; 100 mg/5mL 57896-0661-08 Geri-Care 237 ml — — FDA listed —
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 57896-0736-04 Geri-Care 118 ml — — FDA listed —
Guaiasorb Dm 20 mg/10mL; 200 mg/10mL 57896-0739-04 Geri-Care 118 ml — — FDA listed —
Giltuss HBP Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 58552-0132-04 Gil 1 bottle — — FDA listed —
Giltuss Childrens Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 58552-0133-04 Gil 1 bottle — — FDA listed —
Giltuss Diabetic Cough and Cold 200 mg/10mL; 20 mg/10mL 58552-0134-04 Gil 1 bottle — — FDA listed —
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 58552-0140-04 Gil 1 bottle — — FDA listed —
Childrens Giltuss Honey Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 58552-0141-04 Gil 1 bottle — — FDA listed —
Rompe Pecho DM 10 mg/5mL; 100 mg/5mL 58593-0275-04 Efficient 118 ml — — Discontinued —
Rompe Pechito DM for Kids 5 mg/2.5mL; 50 mg/2.5mL 58593-0276-04 Efficient 118 ml — — FDA listed —
Guaifenesin DM 100 mg/5mL; 10 mg/5mL 60687-0817-17 American 10 cups — — FDA listed —
Guaifenesin DM 200 mg/10mL; 20 mg/10mL 60687-0828-56 American 10 cups — — FDA listed —
ACTINEL Diabetic 10 mg/5mL; 100 mg/5mL 63102-0140-16 ACTIPHARMA, 473 ml — — FDA listed —
Tussin Cough DM Sugar Free 20 mg/10mL; 200 mg/10mL 63868-0869-04 QUALITY 1 bottle — — FDA listed —
Cough and Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 63941-0817-04 Best 1 bottle — — FDA listed —
Childrens Giltuss Honey Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 65852-0003-04 Dextrum 1 bottle — — FDA listed —
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0005-04 Dextrum 1 bottle — — FDA listed —
Giltuss HBP Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0006-04 Dextrum 1 bottle — — FDA listed —
Giltuss Diabetic 20 mg/10mL; 200 mg/10mL 65852-0009-04 Dextrum 1 bottle — — FDA listed —
Giltuss Childrens Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 65852-0019-04 Dextrum 1 bottle — — FDA listed —
SDA Laboratories Tussin DM 10 mg/5mL; 100 mg/5mL 66424-0565-16 SDA 473 ml — — FDA listed —
Adult Tussin DM Lil Drug Store Products 10 mg/5mL; 100 mg/5mL 66715-6858-04 Lil' 1 bottle — — FDA listed —
Tussin DM Cough and Chest Non Drowsy 20 mg/10mL; 200 mg/10mL 67091-0265-18 WinCo 1 bottle — — FDA listed —
Tussin DM Cough and Chest 20 mg/10mL; 200 mg/10mL 67091-0469-04 WinCo 1 bottle — — FDA listed —
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 68071-3938-04 NuCare 118 ml — — FDA listed —
Sorbutuss NR 10 mg/5mL; 100 mg/5mL 68436-0120-16 Dextrum 474 ml — — FDA listed —
Tussin DM 10 mg/5mL; 100 mg/5mL 69168-0477-66 Allegiant 1 bottle — — FDA listed —
Tussin Cough and Chest Congestion DM adult 20 mg/10mL; 200 mg/10mL 69256-0385-08 Harris 1 bottle — — FDA listed —
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0149-19 Natco 10 cups — — FDA listed —
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0150-19 Natco 10 cups — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0035-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0036-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0069-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0812-04 OPMX 118 ml — — FDA listed —
Akin Cough Formula DM 10 mg/5mL; 100 mg/5mL 69822-0202-04 Southern 118 ml — — FDA listed —
MAX Tussin Cough and Chest Congestion DM 20 mg/10mL; 200 mg/10mL 71399-0025-04 Akron 1 bottle — — FDA listed —
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 71399-0026-04 Akron 1 bottle — — FDA listed —
Guaifenesin DM 10 mg/5mL; 100 mg/5mL 71800-0057-05 Innovida 119 ml — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 72162-2277-02 Bryant 237 ml — — FDA listed —
Guaifed DM 200 mg/10mL; 20 mg/10mL 73564-0802-04 Aldama 118 ml — — FDA listed —
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 76281-0503-24 AptaPharma 118 ml — — FDA listed —
Revasol Tussin DM Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 84379-0316-16 Rnv 474 ml — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 84415-0011-01 Everpharm 100 cups — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 84415-0014-01 Everpharm 100 cups — — FDA listed —
Curewell Tussin DM 20 mg/10mL; 200 mg/10mL 85111-0802-16 RMT 473 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 85722-0001-04 KJD 118 ml — — 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.

🔬 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 Altituss (this brand).

Top reported reactions

Dehydration1
Dry Skin1
Feeling Hot1
Hyperhidrosis1
Limb Discomfort1
Speech Disorder1
Tremor1

Reporter sex

1 reports
Male · 100%
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 NDCDescription Marketing startStatus
53163-0113-16 You're viewing this 473 mL in 1 BOTTLE (53163-113-16) 2015-03-01 Active

🧭 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) ✓ 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 FDA registers it as 53163-113-16, 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: 53163-0113-16, written without dashes as 53163011316. 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 53163-0113-16, the first segment (53163) is the labeler code FDA assigned to Alternative Pharmacal Corporation; the middle segment (0113) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Alternative Pharmacal Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alternative Pharmacal Corporation 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 29 words ▾

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

⏱️ Dosage and Administration 65 words ▾

Directions Do not take more than 6 doses in any 24-hour period. Adults and children 12 years of age and over 10 ml (2tsp) every 4 hours Children 6 years to under 12 years of age 5 ml (1tsp) every 4 hours Children 2 years to under 6 years of age 2.5 ml (1/2 tsp) every 4 hours Children under 2 years Consult a doctor

⚠️ Warnings 135 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 you are taking a prescription drug that contains MAOI; ask your 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 When using this product do not use more than directed.

Stop use and ask a doctor before use 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.

🧪 Active Ingredient 21 words ▾

Active Ingredients (in each 7.5 mL) Purpose Dextromethorphan HBr.............. 15 mg ........ Cough suppressant Glyceryl Guaiacolate .................. 150 mg ...... Expectorant

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Artificial and Natural flavor, Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

🎯 Purpose 4 words ▾

Purpose Cough suppressant Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53163-0104-16 · Alternative 53175-0810-43 · Dyad →
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.