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Multi-Symptom Nighttime Cold and Flu Relief Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr 325 mg; 15 mg; 6.25 mg Capsule, Liquid Filled, 50-count — NDC 80513-0316-50 package photo

Multi-Symptom Nighttime Cold and Flu Relief Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr 325 mg; 15 mg; 6.25 mg Capsule, Liquid Filled, 50-count

by Advanced Rx LLC · 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-316-50)
NDC 80513-0316-50
🏷️ FDA NDC (as labeled) 80513-316-50 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ 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 →

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) 80513-316-50
Product NDC 80513-316
11-digit billing NDC 80513031650
RxCUI 1094549
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Application # M012
SPL Set ID a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine Receptor Antagonists; 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 2025-01-01
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 80513-316-50 — 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 → 80513-0316-50. 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 Anilides class.

Drug family (ATC) Anilides
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

LabelerAdvanced Rx LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code80513
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio39 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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter liquid-filled capsule taken by mouth that combines three active ingredients commonly used for nighttime cold and flu symptoms. Acetaminophen is typically used to reduce fever and relieve aches and pain. Dextromethorphan is commonly used to suppress cough. Doxylamine succinate is an antihistamine typically used to help relieve sneezing, runny nose, and congestion, and may also promote drowsiness to aid sleep during illness.

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.

💊 What it looks like

Color green
ShapeOval
ImprintCF02
Size21 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.

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

  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 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.

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

The official label also statesD&C Yellow No10, FD&C Blue No 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution.

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
Night Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 00904-6996-44 Major 1 capsule $0.120 — Availability likely —
Good Neighbor Pharmacy Night Time 325 mg/1; 15 mg/1; 6.25 mg 46122-0245-62 Amerisource 2 capsules $0.120 — Availability likely —
NightTime Cold and Flu Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 70000-0516-01 CARDINAL 1 capsule $0.120 — Availability likely —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 83324-0148-24 QUALITY 1 capsule $0.120 — Availability likely —
good sense night time 325 mg/1; 15 mg/1; 6.25 mg 00113-0056-51 L. 2 capsules $0.132 — Discontinued —
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 00031-8744-10 Haleon 2 capsules — — FDA listed —
Nighttime Cold and Flu 15 mg/1; 6.25 mg/1; 325 mg 00363-0850-24 WALGREENS 12 capsules — — FDA listed —
Walgreens NightTime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 00363-8999-24 WALGREEN 12 capsules — — FDA listed —
Nightime Cold And Flu 15 mg/1; 325 mg/1; 6.25 mg 11673-0976-24 TARGET 12 capsules — — FDA listed —
Multi-Symptom Cold And Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 11822-1987-00 RITE 12 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 11822-3335-05 Rite 1 capsule — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 11822-3392-00 Rite 1 capsule — — FDA listed —
Cold and Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 21130-0849-24 Safeway, 1 capsule — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 21130-0899-24 Safeway, 1 capsule — — FDA listed —
Nighttime cold and flu relief 6.25 mg/1; 325 mg/1; 15 mg 21130-0940-24 BETTER 12 capsules — — FDA listed —
Kroger Nighttime Cold and Flu Softgel 325 mg/1; 15 mg/1; 6.25 mg 30142-0086-48 The 12 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate 325 mg/1; 6.25 mg/1; 15 mg 35916-0154-01 Softgel 12 capsules — — FDA listed —
topcare nite time cold and flu 325 mg/1; 15 mg/1; 6.25 mg 36800-0143-62 Topco 2 capsules — — FDA listed —
night time 325 mg/1; 15 mg/1; 6.25 mg 37808-0056-62 H 2 capsules — — FDA listed —
Nightime 325 mg/1; 15 mg/1; 6.25 mg 37808-0095-16 H-E-B 8 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 37835-0522-24 Bi-Mart 24 capsules — — FDA listed —
Nighttime Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 41163-0849-24 United 1 capsule — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 41163-0899-24 United 1 capsule — — FDA listed —
Nighttime Cold And Flu 15 mg/1; 325 mg/1; 6.25 mg 41226-0694-24 Kroger 12 capsules — — FDA listed —
Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 42507-0056-62 HyVee 2 capsules — — FDA listed —
NiteTime Cold/Flu, Multi-Symptom Relief 325 mg/1; 15 mg/1; 6.25 mg 49035-0978-04 Wal-Mart 12 capsules — — FDA listed —
Tylenol Cold Plus Flu Multi-Symptom Gels Night 15 mg/1; 6.25 mg/1; 325 mg 50580-0131-24 Kenvue 12 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 53345-0006-01 Humanwell 4000 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 53345-0026-01 Humanwell 4000 capsules — — FDA listed —
Night Time Multi-Symptom Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 53943-0603-03 Discount 12 capsules — — FDA listed —
Nighttime Cold/Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55301-0603-03 ARMY 12 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55319-0968-08 Family 1 capsule — — FDA listed —
Sanatos Nighttime 325 mg/1; 15 mg/1; 6.25 mg 55758-0510-08 Pharmadel 8 capsules — — FDA listed —
Cold and Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 55910-0149-48 Dolgencorp, 1 capsule — — FDA listed —
DG Health Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55910-0300-51 Dolgencorp 2 capsules — — Discontinued —
Cold and Flu Relief Nighttime 325 mg/1; 15 mg/1; 6.25 mg 55910-0599-48 Dolgencorp, 1 capsule — — FDA listed —
Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 55910-0910-08 Dolgencorp, 1 capsule — — FDA listed —
nitetime 325 mg/1; 15 mg/1; 6.25 mg 56062-0056-62 Publix 2 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 57243-0603-03 SALADO 12 capsules — — FDA listed —
Nighttime Cold And Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 58602-0769-15 Aurohealth 16 capsules — — FDA listed —
Kroger NightTime Cold and Flu SOFTGEL 325 mg/1; 15 mg/1; 6.25 mg 59450-0047-48 The 12 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 59726-0899-08 P 1 capsule — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 63868-0418-24 QUALITY 1 capsule — — FDA listed —
Night Time Cold and Flu Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 63868-0737-24 QUALITY 1 capsule — — FDA listed —
Circle K Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 66715-5572-08 Lil' 2 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 66715-6716-08 Lil' 2 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 66715-6816-08 Lil' 2 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 67091-0338-24 WinCo 1 capsule — — FDA listed —
NightTime Cold and Flu Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 67091-0395-24 WinCo 1 capsule — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 68016-0798-16 Chain 1 capsule — — Discontinued —
Nighttime Cold And Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 68016-0878-16 Chain 16 capsules — — FDA listed —
DRX CHOICE NIGHTTIME COLD and FLU RELIEF 325 mg/1; 15 mg/1; 6.25 mg 68163-0062-10 Raritan 2 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 69168-0418-29 Allegiant 8 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 69256-0899-24 Harris 1 capsule — — FDA listed —
Vicks NyQuil COLD and FLU 15 mg/1; 6.25 mg/1; 325 mg 69423-0995-02 The 2 capsules — — FDA listed —
Night-Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 69517-0161-10 HealthLife 10 capsules — — FDA listed —
Ampigrin Ultra Forte Night 15 mg/1; 6.25 mg/1; 325 mg 69729-0003-10 OPMX 10 capsules — — FDA listed —
Pentrexcilina Night Time 15 mg/1; 6.25 mg/1; 325 mg 69729-0041-10 OPMX 10 capsules — — FDA listed —
Nitecin 15 mg/1; 6.25 mg/1; 325 mg 69729-0054-10 OPMX 10 capsules — — FDA listed —
Viro Flu PM Relief 15 mg/1; 6.25 mg/1; 325 mg 69729-0057-10 OPMX 10 capsules — — FDA listed —
tabcin NIGHT 15 mg/1; 6.25 mg/1; 325 mg 69729-0153-10 OPMX 10 capsules — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 69842-0847-16 CVS 1 capsule — — FDA listed —
Night Time Cold and Flu Relief Multi Symptom 325 mg/1; 15 mg/1; 6.25 mg 69842-0899-16 CVS 1 capsule — — FDA listed —
Contac Cold And Flu 325 mg/1; 15 mg/1; 6.25 mg 71179-0003-08 VESPYR 8 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 71679-0102-00 Health 1500 capsules — — FDA listed —
basic care nighttime cold and flu 325 mg/1; 15 mg/1; 6.25 mg 72288-0056-62 Amazon.com 2 capsules — — FDA listed —
Nighttime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 72476-0899-24 Care 1 capsule — — FDA listed —
Nite Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 76162-0026-16 TopCo 8 capsules — — FDA listed —
NightTime Cold and Flu 325 mg/1; 15 mg/1; 6.25 mg 76168-0056-02 Velocity 1 capsule — — FDA listed —
Night Time Cold and Flu relief liquid filled softgels 325 mg/1; 15 mg/1; 6.25 mg 76281-0603-03 AptaPharma 12 capsules — — FDA listed —
meijer Nighttime Cold and Flu SOFTGEL 325 mg/1; 15 mg/1; 6.25 mg 79481-0808-04 Meijer, 12 capsules — — FDA listed —
meijer Nighttime Cold and Flu SOFTGEL 325 mg/1; 15 mg/1; 6.25 mg 79481-0828-04 Meijer, 12 capsules — — FDA listed —
Nighttime Cold And Flu Relief Softgels Multi-Symptom 15 mg/1; 6.25 mg/1; 325 mg 80513-0302-50 Advanced 50 capsules — — FDA listed —
Nighttime Cold And Flu Relief 15 mg/1; 6.25 mg/1; 325 mg 80513-0304-50 Advanced 50 capsules — — FDA listed —
Multi-Symptom Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mgthis 80513-0316-50 Advanced 50 capsules — — FDA listed —
Night Time Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 81522-0899-16 FSA 1 capsule — — FDA listed —
AXIV NightTime 325 mg/1; 15 mg/1; 6.25 mg 82706-0016-01 VIVUNT 8 capsules — — FDA listed —
Nighttime Cold and Flu Multi Symptom Relief 325 mg/1; 15 mg/1; 6.25 mg 83059-0024-01 Shield 10 capsules — — Discontinued —
Nighttime Cold and Flu Multi Symptom Relief 325 mg/1; 15 mg/1; 6.25 mg 83059-0112-01 Shield 10 capsules — — Discontinued —
Nuvicare NightTime Cold and Flu Softgel 325 mg/1; 15 mg/1; 6.25 mg 84324-0019-01 NUVICARE 10 capsules — — FDA listed —
Nuvicare NightTime Cold and Flu Softgel 325 mg/1; 15 mg/1; 6.25 mg 84324-0024-01 NUVICARE 10 capsules — — FDA listed —
Dr. Simi Nighttime Cold and Flu 15 mg/1; 6.25 mg/1; 325 mg 85786-0602-24 Farmacias 12 capsules — — FDA listed —
Nighttime Cold and Flu Relief 325 mg/1; 15 mg/1; 6.25 mg 85828-0418-93 Grocery 24 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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 Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr — the ingredient across all brands.

Top reported reactions

Covid-19174
Disease Recurrence135
Nasopharyngitis134
Fatigue107
Cough101
Nausea100
Diarrhoea82

Age at onset

Child2
Adolescent8
Adult194
Elderly68

Reporter sex

1,440 reports
Male · 36%
Female · 64%

Serious outcomes

Hospitalization290
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 225 55
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80513-0316-50 You're viewing this 50 CAPSULE, LIQUID FILLED in 1 BOTTLE (80513-316-50) 2025-01-01 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 80513-316-50, 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: 80513-0316-50, written without dashes as 80513031650. 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 80513-0316-50, the first segment (80513) is the labeler code FDA assigned to Advanced Rx LLC; the middle segment (0316) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Advanced Rx LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx 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.

📄 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 28 words ▾

Uses Temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

⏱️ Dosage and Administration 44 words ▾

Direction take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly Do not use with any other drug containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

🧪 Active Ingredient 16 words ▾

Active ingredients (in each Softgels) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients D&C Yellow No10, FD&C Blue No 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution.

🎯 Purpose 7 words ▾

Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80513-0311-06 · Advanced 80513-0362-15 · Advanced →
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.