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Maximum Strength Daytime Severe and Nighttime Cold and Flu Daytime- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Nighttime - Acetaminophen, Diphenhydramine HCI Kit — NDC 11673-0794-01 package photo

Maximum Strength Daytime Severe and Nighttime Cold and Flu Daytime- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Nighttime - Acetaminophen, Diphenhydramine HCI Kit

by TARGET Corporation · 1 KIT in 1 KIT (11673-794-01) * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC
NDC 11673-0794-01
🏷️ FDA NDC (as labeled) 11673-794-01 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) 11673-794-01
Product NDC 11673-794
11-digit billing NDC 11673079401
RxCUI 1116572, 1375932, 1424850, 2374554, 2680300
UPC 0349580463127
Application # M012
SPL Set ID 0bf9c0df-7676-3060-e063-6394a90a16c7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-01
Dosage form KIT
Why two NDCs? The FDA registers this code as 11673-794-01 — 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 → 11673-0794-01. 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 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 Corporation
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code11673
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio408 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 combination kit containing two different cold and flu products marketed under FDA's OTC monograph rules. The daytime formula contains acetaminophen (a fever and pain reliever), dextromethorphan (a cough suppressant), and guaifenesin (an expectorant used to help thin mucus). The nighttime formula contains acetaminophen along with diphenhydramine (an antihistamine commonly used to relieve cold symptoms and promote drowsiness). The kit is designed to address different symptom needs during daytime and nighttime hours.

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.

🧪 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.

From the label’s inactive-ingredient sectionNighttime citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum Daytime citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Daytime Severe and Nighttime Cold and Fluthis 11673-0794-01 TARGET 1 kit — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11673-0794-01 You're viewing this 1 KIT in 1 KIT (11673-794-01) * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC 2024-05-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 11673-794-01, 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: 11673-0794-01, written without dashes as 11673079401. 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 11673-0794-01, the first segment (11673) is the labeler code FDA assigned to TARGET Corporation; the middle segment (0794) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TARGET 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 77 words ▾

Uses Nighttime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep Daytime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

⏱️ Dosage and Administration 151 words ▾

Directions Nighttime do not take more than directed (see overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = mililiter dose as follows or as directed by a doctor adults and children 12 years and older: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use Daytime do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24-hours period measure only with dosing cup provided.

Do not use any other dosing device. dose as follows or as directed by a doctor keep dosing cup with product mL = milliliter adults and children 12 years of age and older: 20 mL every 4 hours children under 12 years of age: do not use

⚠️ Warnings ~3 min read ▾

Warnings NIGHTTIME and DAYTIME Liver warnin g: This product contain acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 Nighttime with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin 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 for children under 12 years of age Daytime 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. for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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. Ask a doctor before use if you have Nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Daytime liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are Nighttime you are taking the blood thinning drug warfarin you are taking sedative or tranquilizers Daytime taking the blood thinning drug warfarin When using these products Nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicile or operating machinery Daytime do not use more than directed Stop use and ask a doctor if Nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last 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 a signs of a serious condition Daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, 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. If pregnant or breast-feeding, Nighttime and DayTime ask a health professional before use.

Keep out of reach of children. Nighttime and DayTime Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Quick m…

📦 Storage and Handling 33 words ▾

Other information Nighttime each 20 mL contains : sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate. Daytime each 20 mL contains : 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

🧪 Active Ingredient 41 words ▾

Active ingredients for Nighttime (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCI 25 mg Phenylephrine HCI 10 mg

Active ingredients for Daytime (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifeenesin 400 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 56 words ▾

Inactive ingredients Nighttime citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum Daytime citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

🎯 Purpose 23 words ▾

Purpose for Nighttime Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant

Purpose for Daytime Pain reliever / fever reducer Cough suppressant Expectorant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11673-0793-15 · Target 11673-0795-05 · TARGET →
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.