Severe Cold and Flu Daytime, Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Kit — NDC 51316-509-08 (Billing 51316-0509-08)
This is a package of Severe Cold and Flu Daytime, Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl Kit from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 51316-509-08 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 51316 labeler · 509 product · 08 package
- Package marketed since
- Mar 6, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5131650908 5
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1086991
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗This is an over-the-counter kit containing two multi-ingredient products labeled for daytime and nighttime cold and flu symptom relief. The kit includes acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant to help thin mucus), phenylephrine (a nasal decongestant), and chlorpheniramine maleate (an antihistamine to relieve sneezing and runny nose). These products are marketed under FDA's over-the-counter monograph guidelines for cold and flu symptom management.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 51316-0509-08 You're viewing this Main listing | 1 KIT in 1 CARTON * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK | 2026-03-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Severe Cold and Flu Daytime, Nighttimethis 51316-0509-08 | CVS | 8 tablets | — | — | FDA listed | — |
| Severe Cold and Flu Relief Daytime/Nighttime 69842-0803-08 | CVS | 8 tablets | — | — | FDA listed | — |
| COLD AND FLU SEVERE Daytime, Nighttime 79481-5034-08 | Meijer | 1 kit | — | — | FDA listed | — |
| Cold and Flu Day and Night, Severe 55301-0547-08 | ARMY | 1 kit | — | — | FDA listed | — |
| Cold and Flu Severe, Daytime, Nighttime 11822-5034-08 | Rite | 8 tablets | — | — | FDA listed | — |
| Cold and Flu Severe Day Time / Night Time 55910-0573-08 | DOLGENCORP, | 8 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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.
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?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED labeler code 51316
- Night Time Cough Dextromethorphan HBr, Doxylamine Succinate 30 mg/30mL; 12.5 mg/30mL Liquid NDC 51316-499-12
- Cough and Congestion Dextromethorphan HBr, Guaifenesin 20 mg/20mL; 400 mg/20mL Solution NDC 51316-500-19
- Burn Relief Lidocaine 40 mg/g Aerosol, Spray NDC 51316-501-04
- Loratadine 5 mg Tablet, Orally Disintegrating NDC 51316-502-01
- Loratadine 10 mg Tablet, Orally Disintegrating NDC 51316-503-01
- 8 hr arthritis pain acetaminophen 650 mg Tablet, Film Coated, Extended Release NDC 51316-504-79
- CVS Ultra Strength Muscle Menthol, Camphor, Methyl Salicylate 40 mg/mL; 300 mg/mL; 100 mg/mL Cream NDC 51316-510-03
- ACID REDUCER Famotidine 20 mg Tablet, Film Coated NDC 51316-511-63
- childrens cold cough brompheniramine maleate, dextromethorphan hydrobromide 2 mg/10mL; 10 mg/10mL Solution NDC 51316-513-26
- Supreme Antacid Cherry calcium carbonate, magnesium hydroxide 135 mg/5mL; 400 mg/5mL Liquid NDC 51316-515-05
- Mucus Relief Sinus Severe Congestion and Pain Acetaminophen, Guaifenesin, Phenylephrine HCl 325 mg; 200 mg; 5 mg Tablet, Film Coated NDC 51316-516-09
- Arthritis Pain Relief Diclofenac Sodium 10 mg/g Gel NDC 51316-517-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure sneezing and runny nose (nighttime only) helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (daytime only) helps clear nasal passages relieves cough to help you sleep temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
⚠️ Warnings ▾
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. 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) 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 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, ask a health professional before use. 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. Do not take DAYTIME and NIGHTTIME products at the same time.
📦 Storage and Handling ▾
Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
🧪 Active Ingredient ▾
Active ingredients (in each caplet) (daytime) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Active ingredients (in each caplet) (nighttime) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients (daytime only) corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Inactive ingredients (nighttime only) corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
🎯 Purpose ▾
Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant
📄 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.
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only)
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only)
📄 When Using This Product ▾
When using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only)
📄 Stop Use and Ask a Doctor If ▾
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 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 ▾
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. Do not take DAYTIME and NIGHTTIME products at the same time.
📄 Questions or Comments ▾
Questions or comments? 1-800-426-9391
📄 Package Label / Principal Display Panel ▾
Principal display panel NDC 51316-509-08 ♥CVS ™ Daytime SEVERE COLD & FLU Acetaminophen Pain Reliever, Fever Reducer Dextromethorphan HBr, Cough Suppressant Guaifenesin, Expectorant Phenylephrine HCl, Nasal Decongestant Nighttime SEVERE COLD & FLU Acetaminophen Pain Reliever, Fever Reducer Chlorpheniramine Maleate, Antihistamine Dextromethorphan HBr, Cough Suppressant Phenylephrine HCl, Nasal Decongestant Compare to Tylenol® Cold + Flu Severe Day & Night active ingredients* Relieves: Fever, Headache, Sore throat, Nasal & chest congestion, Cough, Mucus 16 CAPLETS actual size Relieves: Fever, Headache, Sore throat, Runny nose, Cough, Nasal congestion 8 CAPLETS actual size 24 TOTAL CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Do Not Take Daytime and Nighttime Products at the Same Time. *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® Cold + Flu Severe Day & Night.
50844 ORG082550347308 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 100% money back guaranteed. CVS.com/returnpolicy CVS 44-503A473C CVS 44-503A473C
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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About this NDC listing & data coverage
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. |