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Severe Cold and Cough Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 650 mg; 25 mg; 10 mg Powder, For Solution, 6 packets — NDC 67091-0323-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Severe Cold and Cough Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 650 mg; 25 mg; 10 mg Powder, For Solution, 6 packets — NDC 67091-323-06 (Billing 67091-0323-06)

by WinCo Foods, LLC · 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET

This is a package of 6 packets of Severe Cold and Cough Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE 650 mg; 25 mg; 10 mg Powder, For Solution from WinCo Foods, LLC, marketed since Aug 2018 and currently FDA-listed. It is this product's only package size.

NDC 67091-0323-06
🏷️ FDA NDC (as labeled) 67091-323-06 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 67091-323-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67091 labeler · 323 product · 06 package
Package marketed since
Aug 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6709132306 8
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67091-323-06
Product NDC 67091-323
11-digit billing NDC 67091032306
RxCUI 1659960
UNII 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
Application # M012
SPL Set ID dc56197c-c108-4b35-b791-dde5c3384ddd
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-01
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1659960
Why two NDCs? The FDA registers this code as 67091-323-06 — 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 → 67091-0323-06. 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.

Clinical

🧪 What is this product?

This is an over-the-counter powder meant to be mixed with liquid and taken by mouth for nighttime cold and cough relief. It contains acetaminophen, which is typically used to reduce fever and relieve pain, along with diphenhydramine, an antihistamine commonly included in cold products to help with congestion and coughing. Phenylephrine is a decongestant that functions to help clear nasal passages. This product is marketed under FDA's over-the-counter drug rules for its category.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67091-0323-06 You're viewing this Main listing 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET 2018-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Quality Choice Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mg 63868-0291-06 Chain 6 packets $0.482 — FDA listed —
Theraflu Powerpods Nighttime Severe Cold 650 mg/1; 25 mg/1; 10 mg 00067-6095-01 Haleon 8 pouches — — FDA listed —
Theraflu Severe Cold Relief Nighttime 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-6803-02 Haleon 6 packets — — FDA listed —
Theraflu Nighttime Severe Cold And Cough 650 mg/237mL; 25 mg/237mL; 10 mg/237mL 00067-7918-06 Haleon 6 packets — — FDA listed —
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor 650 mg/1; 25 mg/1; 10 mg 00067-8212-01 Haleon 6 packets — — FDA listed —
Nighttime Wal Flu Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 00363-5410-06 WALGREEN 6 powders — — FDA listed —
up and up nighttime flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 11673-0113-07 Target 6 powders — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 41226-0541-06 KROGER 6 powders — — FDA listed —
Equate Flu and Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 49035-0964-91 Wal-Mart 6 powders — — FDA listed —
SanaTos Severe Cold Relief Nighttime 25 mg/1; 10 mg/1; 650 mg 55758-0385-06 Pharmadel 6 granules — — FDA listed —
dg health flu and severe cold and cough 650 mg/1; 25 mg/1; 10 mg 55910-0964-91 Dolgencorp, 6 powders — — FDA listed —
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 10 mg/5g; 650 mg/5g; 25 mg/5g 58933-0551-01 Procter 5 g — — FDA listed —
Severe Cold and Cough Nighttime 650 mg/1; 25 mg/1; 10 mgthis 67091-0323-06 WinCo 6 packets — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/1; 25 mg/1; 10 mg 68163-0541-06 RARITAN 6 packets — — FDA listed —
Basic Care severe cold and cough 650 mg/1; 25 mg/1; 10 mg 72288-0964-91 Amazon.com 6 packets — — 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerWinCo Foods, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code67091
First marketedAug 2018
Product typeHuman Otc Drug
Portfolio138 products on file

More NDCs from WinCo Foods, LLC labeler code 67091

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 58 words ▾

Uses ▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever

⏱️ Dosage and Administration 98 words ▾

Directions ▪ do not use more than directed ▪ take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

⚠️ Warnings 103 words ▾

Warnings Liver warning: This product contains 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.

📦 Storage and Handling 20 words ▾

Other information ▪ each packet contains: potassium 6 mg ▪ store at room temperature. Protect from excessive heat and moisture.

🧪 Active Ingredient 16 words ▾

Active ingredients (in each packet) Acetaminophen, 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

🎯 Purpose 12 words ▾

Purposes Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE — the ingredient across all brands.

Top reported reactions

Nonspecific Reaction1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by WinCo Foods, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WinCo Foods, 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.
← 67091-0322-06 · WinCo 67091-0324-30 · WinCo →
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.