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Night Time Severe Cold and Cough Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL 325 mg/15mL; 12.5 mg/15mL; 5 mg/15mL Liquid, 245 mL — NDC 68016-0154-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Night Time Severe Cold and Cough Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL 325 mg/15mL; 12.5 mg/15mL; 5 mg/15mL Liquid, 245 mL — NDC 68016-154-08 (Billing 68016-0154-08)

by Chain Drug Consortium, LLC · 245 mL in 1 BOTTLE

This is a package of 245 mL of Night Time Severe Cold and Cough Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL 325 mg/15mL; 12.5 mg/15mL; 5 mg/15mL Liquid from Chain Drug Consortium, LLC, marketed since Oct 2013 and currently FDA-listed. It is this product's only package size.

NDC 68016-0154-08
🏷️ FDA NDC (as labeled) 68016-154-08 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 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

NDC database record

One package, one record: these facts belong to NDC 68016-154-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68016 labeler · 154 product · 08 package
Package marketed since
Oct 4, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
245 mL per package
Barcode (UPC)
0840986022845
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-154-08
Product NDC 68016-154
11-digit billing NDC 68016015408
NCPDP billing unit ML — per mL (volume)
RxCUI 1298348
UNII 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
UPC 0840986022845
Application # M013
SPL Set ID c8e9b57b-83e9-46c5-9791-02c4c2b94004
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 2013-10-04
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 063195
GCN 98952
HICL code 035433
Ingredient (HICL) Diphenhyd/Phenyleph/Acetaminop
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3O
Therapeutic class — specific (HIC3) 1St Gen Antihistamine-Decongestant-Analgesic Comb
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name PV FLU RELIEF THERAPY LIQUID
FDB brand name Flu Relief Therapy
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 063195
  • GCN: 98952
  • HICL (First Databank): 035433
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1298348
Why two NDCs? The FDA registers this code as 68016-154-08 — 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 → 68016-0154-08. 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

Label name PV FLU RELIEF THERAPY LIQUID Ingredient Diphenhyd/Phenyleph/Acetaminop
📖 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 oral liquid OTC cold and cough product containing three active ingredients. Acetaminophen is typically used to reduce fever and relieve pain. Diphenhydramine hydrochloride is an antihistamine commonly used to reduce cold and allergy symptoms like sneezing and runny nose, and also functions as a sleep aid. Phenylephrine hydrochloride is a decongestant typically used to relieve nasal congestion. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for this category of medication.

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
68016-0154-08 You're viewing this Main listing 245 mL in 1 BOTTLE 2013-10-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Theraflu ExpressMax Nighttime Severe Cold and Cough 650 mg/30mL; 25 mg/30mL; 10 mg/30mL 00067-8129-08 Haleon 245.5 ml — — FDA listed —
Nighttime Severe Cold and Cough 650 mg/30mL; 25 mg/30mL; 10 mg/30mL 49580-0502-08 P 245 ml — — FDA listed —
Night Time Severe Cold and Cough Relief 325 mg/15mL; 12.5 mg/15mL; 5 mg/15mLthis 68016-0154-08 Chain 245 ml — — 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

🏛️
2013
On the market since
Oct 2013
📍
2026
Currently FDA-listed
13 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.

What it looks like

FlavorCherry
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

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

The official label also statesAcesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

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.

Manufacturer & labeler

LabelerChain Drug Consortium, LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedOct 2013
Product typeHuman Otc Drug
Portfolio49 products on file

More NDCs from Chain Drug Consortium, LLC labeler code 68016

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 🆘 Overdosage 🧪 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 47 words ▾

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal and sinus congestion runny nose sneezing itchy watery eyes itchy nose or throat cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever

⏱️ Dosage and Administration 64 words ▾

Directions Age Dose Children under 4 years Do not use Children 4 to under 12 years of age Do not use unless directed by a doctor Adults and children 12 years and over 2 tablespoonful (30 mL) every 4 hours take only as recommended (see Overdose warning) use dose cup or tablespoon (TBSP) do not take more than 6 doses in any 24-hour period

⚠️ Warnings 43 words ▾

Warnings Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 dose in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product

🆘 Overdosage 50 words ▾

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 21 words ▾

Drug facts Active ingredients Active ingredients (in each tablespoonful 15 mL) Acetaminophen 325 mg Diphenhydramine HCL 12.5 mg Phenylephrine HCL 5mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

🎯 Purpose 8 words ▾

Purpose Pain reliever/Fever reducer Cough suppressant/Antihistamine Nasal decongestant

📄 Do Not Use 97 words ▾

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 taking a prescription monamine 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 with any other drug containing diphenhydramine, even one used on the skin for children under 4 years of age

📄 Ask a Doctor Before Use If 50 words ▾

Ask a doctor before use if you have liver disease heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema cough that occurs with too much phlegm (mucus)

📄 Ask a Doctor or Pharmacist Before Use If 19 words ▾

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

📄 When Using This Product 43 words ▾

When using this product do not use more than directed (see overdose warning) excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 67 words ▾

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children Keep out of reach of children

📄 Questions or Comments 12 words ▾

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

📄 Package Label / Principal Display Panel 134 words ▾

Product Label NDC 6801-154-08 *COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION Premier Value® Night Time Severe Cold and Cough Relief Acetaminophen ............ Pain Reliever/Fever Reducer Diphenhydramine.......... Antihistamine/Cough Suppressant Phenylephrine HCL ...... Nasal Congestion Fever and Body Aches Sore Throat Headache Nasal Congestion Runny Nose Cough Cherry Flavor

8.3FL OZ (245 mL) PV Independently Tested Satisfaction Guaranteed LF-007 DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING Failure to follow these warnings could result in consequences LB-007 DISTRIBUTED BY CHAIN DRUG CONSORTIUM 3301 NW BOCA RATON BLVD SUITE 101 BOCA RATON, FL 33431 Lot: Exp: *This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time AptaPharma 154-1 Label AptaPharma 154-2 Label AptaPharma154-3 Label AptaPharma154-4 Label

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

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 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 Chain Drug Consortium, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chain Drug Consortium, 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.
← 68016-0152-01 · Pharmacy 68016-0159-02 · Pharmacy →
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.