COLD AND FLU NIGHTTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL 5 mg; 325 mg; 10 mg; 6.25 mg Capsule, Liquid Filled, 8-count — NDC 11673-0983-08 package photo

COLD AND FLU NIGHTTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL 5 mg; 325 mg; 10 mg; 6.25 mg Capsule, Liquid Filled, 8-count

by TARGET CORP · 1 BLISTER PACK in 1 CARTON (11673-983-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 11673-0983-08
🏷️ FDA NDC (as labeled) 11673-983-08 billing pads the product segment with a zero
This package
Contains8-count Pack sizes2 compare ↓
Also comes in: 12 capsules 11673-0983-24
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 →

🆔 Identity & classification

FDA NDC (as labeled) 11673-983-08
Product NDC 11673-983
11-digit billing NDC 11673098308
RxCUI 1297288
UNII 04JA59TNSJ, 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Application # M012
SPL Set ID 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Receptor Antagonists [MoA
Mechanism of action Adrenergic alpha1-Agonists; Histamine Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-01
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 11673-983-08 — 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 → 11673-0983-08. 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

LabelerTARGET CORP
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code11673
First marketedJun 2020
Product typeHuman Otc Drug
Portfolio9 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

🧪 What is this product?

This is an over-the-counter nighttime cold and flu product in liquid-filled capsule form taken by mouth. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan, a cough suppressant; phenylephrine, a nasal decongestant; and doxylamine succinate, an antihistamine typically used to promote drowsiness. The combination is designed for people seeking symptom relief during nighttime hours when multiple cold or flu complaints are present.

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
ShapeBullet
Imprint72
Size16 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 statesFD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

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 DailyMedingredient 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.
Try another pack size: 12 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 00280-0097-01 Bayer 8 capsules FDA listed
Alka-Seltzer Plus Maximum Strength Night Cold and Flu 10 mg/1; 325 mg/1; 6.25 mg/1; 5 mg 00280-1600-20 Bayer 10 capsules FDA listed
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 00280-1620-20 Bayer 10 capsules FDA listed
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 00280-1640-16 Bayer 8 capsules FDA listed
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 00280-8276-16 Bayer 8 capsules FDA listed
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 00280-8282-24 Bayer 8 capsules FDA listed
NIGHTTIME COLD AND FLU Maximum Strength 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 00363-1011-24 WALGREENS 12 capsules FDA listed
Severe Nighttime Cold And Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 00363-8997-24 WALGREENS 12 capsules FDA listed
Cold And Flu Nighttime Severe 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mgthis 11673-0983-08 TARGET 8 capsules FDA listed
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 35916-0167-01 SOFTGEL 12 capsules FDA listed
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 35916-0186-01 Softgel 3000 capsules FDA listed
Vicks NyQuil Severe Cold and Flu 10 mg/1; 6.25 mg/1; 5 mg/1; 325 mg 37000-0518-02 The 2 capsules FDA listed
Severe Sinus Congestion Allergy and Cough Formula 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 51013-0169-08 PuraCap 10 capsules FDA listed
Night Time Severe Cold and Flu Relief 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 51013-0175-04 PuraCap 12 capsules FDA listed
Nighttime Severe Cold And Flu 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 51316-0526-24 CVS 24 capsules FDA listed
Night Cold Flu Cough and Allergy 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 53345-0020-01 Humanwell 4000 capsules FDA listed
ASP Nighttime Max 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 53345-0053-01 Humanwell 4000 capsules FDA listed
Maximum Strenth Night Cold And Flu Formula 10 mg/1; 5 mg/1; 6.25 mg/1; 325 mg 55319-0934-08 FAMILY 8 capsules FDA listed
Maximum Strength Nighttime Severe Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 68210-4210-01 Prodose, 10 capsules FDA listed
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 70692-0837-84 Strive 48 capsules FDA listed
Night Time Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 72476-0998-14 Retail 8 capsules FDA listed
NiteTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 76162-0637-24 Topco 12 capsules FDA listed
TopCare Nite Time SEVERE Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 76162-0812-24 Topco 12 capsules FDA listed
Nighttime Severe Cold And Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 79903-0134-24 Wal-Mart 12 capsules FDA listed
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 79903-0387-24 WALMART 12 capsules FDA listed
QUALITY CHOICE NightTime Severe Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 83324-0038-24 Chain 12 capsules FDA listed
QUALITY CHOICE Maximum Strength Nighttime Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 83324-0224-24 Chain 12 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

🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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 ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL — the ingredient across all brands.

Top reported reactions

Dyspnoea3
Vomiting3
Chills2
Dizziness2
Headache2
Hypersensitivity2
Nasopharyngitis2

Reporter sex

23 reports
Male · 25%
Female · 75%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11673-0983-08 You're viewing this 1 BLISTER PACK in 1 CARTON (11673-983-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2020-06-01 Active
11673-0983-24 2 BLISTER PACK in 1 CARTON (11673-983-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2020-06-01 Active

Pack size FAQ

What quantity is in NDC 11673-0983-08?
NDC 11673-0983-08 is a 8-count package — 1 blister pack in 1 carton / 8 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of COLD AND FLU NIGHTTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL 5 mg; 325 mg; 10 mg; 6.25 mg Capsule, Liquid Filled?
Bill NDC 11673-0983-08 — the 11-digit billing format is 11673098308. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 11673-983-08, 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: 11673-0983-08, written without dashes as 11673098308. 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 11673-0983-08, the first segment (11673) is the labeler code FDA assigned to TARGET CORP; the middle segment (0983) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 TARGET CORP. 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 1 other package presentation of this same product, including 12 capsules (11673-0983-24). 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?
TARGET CORP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 53 words

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

⏱️ Dosage and Administration 43 words

Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over: 2 softgels with water every 4 hrs children 4 to under 12 yrs: ask a doctor children under 4 yrs: do not use

⚠️ Warnings 105 words

Warnings Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels 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.

📦 Storage and Handling 7 words

Other information • do not exceed 25°C

🧪 Active Ingredient 20 words

Active ingredients( in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 18 words

FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

🎯 Purpose 9 words

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.