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Cold and Flu Nighttime Severe, 24-7 Life acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 325 mg; 10 mg; 6.25 mg; 5 mg Tablet, Film Coated — NDC 66715-6516-8 (Billing 66715-6516-08)

by Lil' Drug Store products, Inc. · 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Cold and Flu Nighttime Severe, 24-7 Life acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 325 mg; 10 mg; 6.25 mg; 5 mg Tablet, Film Coated from Lil' Drug Store products, Inc., marketed since Apr 2022 and currently FDA-listed. It is this product's only package size.

NDC 66715-6516-08
🏷️ FDA NDC (as labeled) 66715-6516-8 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 66715-6516-8 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
66715 labeler · 6516 product · 8 package
Package marketed since
Apr 19, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0052548725136
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 66715-6516-8
Product NDC 66715-6516
11-digit billing NDC 66715651608
RxCUI 1546881
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
UPC 0052548725136
Application # M012
SPL Set ID 05d0410f-164e-e7ee-e063-6394a90a2aaa
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 2022-04-19
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1546881
Why two NDCs? The FDA registers this code as 66715-6516-8 — a 5-4-1 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 package segment → 66715-6516-08. 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.

Clinical

🧪 What is this product?

This is an over-the-counter monograph tablet taken by mouth, containing four active ingredients typically used together for nighttime cold and flu relief. Acetaminophen functions as a pain reliever and fever reducer. Dextromethorphan is commonly used to suppress cough, while doxylamine succinate is a sleep aid that helps with rest during illness. Phenylephrine hydrochloride functions as a nasal decongestant to help relieve stuffiness.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
66715-6516-08 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK 2022-04-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Severe Nighttime Cold and Flu Relief 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 11822-0677-08 Rite 12 tablets — — FDA listed —
Cold and Flu Nighttime Severe 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 29485-5053-06 Lil' 6 tablets — — FDA listed —
topcare nite time cold and flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 36800-0307-62 Topco 2 tablets — — FDA listed —
NyQuil Severe plus Vicks VapoCool Cold and Flu 10 mg/1; 325 mg/1; 5 mg/1; 6.25 mg 37000-0523-02 The 2 tablets — — FDA listed —
Nite time Severe Cold and Flu Maximum Strength 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 41250-0877-08 Meijer 12 tablets — — FDA listed —
equate vapor ice cold and flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 49035-0708-62 Wal-Mart 2 tablets — — FDA listed —
Cold and Flu Nighttime Severe 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 50844-0677-21 L.N.K. 8 tablets — — FDA listed —
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX 325 mg/1; 5 mg/1; 6.25 mg/1; 10 mg 66715-6405-02 Lil' 2 tablets — — FDA listed —
Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven 10 mg/1; 325 mg/1; 5 mg/1; 6.25 mg 66715-6505-03 Lil' 6 tablets — — FDA listed —
Cold and Flu Nighttime Severe, 24-7 Life 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mgthis 66715-6516-08 Lil' 8 tablets — — FDA listed —
NyQuil Severe Plus VapoCOOL Cold and Flu, CVP HEALTH 325 mg/1; 5 mg/1; 6.25 mg/1; 10 mg 66715-6581-02 Lil' 2 tablets — — FDA listed —
NyQuil Severe Plus VapoCOOL Cold and Flu 325 mg/1; 5 mg/1; 6.25 mg/1; 10 mg 66715-9905-02 Lil' 2 tablets — — FDA listed —
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTION 325 mg/1; 5 mg/1; 6.25 mg/1; 10 mg 69423-0986-02 The 2 tablets — — FDA listed —
basic care nighttime severe cold and flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 72288-0721-62 Amazon.com 2 tablets — — 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

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 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

LabelerLil' Drug Store products, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code66715
First marketedApr 2022
Product typeHuman Otc Drug
Portfolio187 products on file

More NDCs from Lil' Drug Store products, Inc. labeler code 66715

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

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

⏱️ Dosage and Administration 40 words ▾

Directions Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings ​Warnings Liver warning 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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning 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 Do not use with any other drug containing acetaminophen (prescription or nonprescription). 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 Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease glaucoma high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor Stop use and ask a doctor if 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 presen 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 22 words ▾

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

🧪 Inactive Ingredients 46 words ▾

Inactive ingredients Inactive ingredients black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

🎯 Purpose 10 words ▾

Purpose ​Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

📄 Do Not Use 98 words ▾

Do not use Do not use with any other drug containing acetaminophen (prescription or nonprescription). 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 60 words ▾

Ask a doctor before use Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease glaucoma high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

📄 Ask a Doctor or Pharmacist Before Use If 28 words ▾

Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin

📄 When Using This Product 43 words ▾

When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

📄 Stop Use and Ask a Doctor If 67 words ▾

Stop use and ask a doctor Stop use and ask a doctor if 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 presen 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 14 words ▾

If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 49 words ▾

Keep out of reach of children. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 7 words ▾

Questions or comments? Questions or comments? 1-877-507-6516

📄 Package Label / Principal Display Panel 75 words ▾

Cold & Flu Nighttime Severe, 16ct, 24/7 Life - PDP/Package [24/7 Life logo] Cold & Flu Nighttime Severe Acetaminophen / Pain Reliever/Fever Reducer Dextromethorphan HBr /Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine HCl / Nasal Decongestant Relieves: Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal Congestion, Sinus Pressure, Sneezing, Runny Nose, Cough compare to Vicks ® NyQuil ® VapoCOOL™ SEVERE Cold & Flu + Congestion active ingredients* 16 CAPLETS Actual Size [caplet image] PDP/Package

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, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl — the ingredient across all brands.

Top reported reactions

Dyspnoea3
Vomiting3
Chills2
Dizziness2
Headache2
Hypersensitivity2
Nasopharyngitis2

Age at onset

Adult1
Elderly1

Reporter sex

22 reports
Male · 21%
Female · 79%

Serious outcomes

Hospitalization5
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5 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 — Not published for this NDC No photo available yet for this listing.
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 Lil' Drug Store products, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lil' Drug Store products, Inc. 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.
← 66715-6515-08 · Lil' 66715-6517-02 · Lil' →
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.