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Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr Kit — NDC 51316-984-03 (Billing 51316-0984-03)

by CVS Pharmacy, Inc · 1 KIT in 1 CARTON * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr Kit from CVS Pharmacy, Inc, marketed since Jul 2024 and currently FDA-listed. It is this product's only package size.

NDC 51316-0984-03
🏷️ FDA NDC (as labeled) 51316-984-03 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 51316-984-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51316 labeler · 984 product · 03 package
Package marketed since
Jul 10, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0050428137284
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51316-984-03
Product NDC 51316-984
11-digit billing NDC 51316098403
RxCUI 247324, 1098496, 2604579
UPC 0050428137284
Application # M012
SPL Set ID 31aa77e0-cfdb-57a8-e063-6394a90af98c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-10
Route ORAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 247324
Why two NDCs? The FDA registers this code as 51316-984-03 — 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 → 51316-0984-03. 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 oral over-the-counter combination kit containing acetaminophen, chlorpheniramine maleate, and dextromethorphan HBr. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Chlorpheniramine maleate is an antihistamine commonly used to relieve allergy and cold symptoms such as sneezing and runny nose. Dextromethorphan is typically used as a cough suppressant. This product is marketed under the FDA's over-the-counter monograph rules for combination cold and allergy preparations.

1
Nutrient depletion considerations

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
51316-0984-03 You're viewing this Main listing 1 KIT in 1 CARTON * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK 2024-07-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBrthis 51316-0984-03 CVS 10 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

🏛️
2024
On the market since
Jul 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.

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

LabelerCVS Pharmacy, Inc
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio104 products on file

More NDCs from CVS Pharmacy, Inc labeler code 51316

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 66 words ▾

Uses temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains cough due to minor throat and bronchial irritation minor sore throat pain temporarily reduces fever

Uses temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains cough due to minor throat and bronchial irritation minor sore throat pain runny nose temporarily reduces fever

⏱️ Dosage and Administration 149 words ▾

Directions do not use more than directed adults and children 12 years of age and over : take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use

Directions do not use more than directed adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age do not use

⚠️ Warnings ~3 min read ▾

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. in a child under 12 years of age if you are allergic to acetaminophen 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. liver disease a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema taking the blood thinning drug warfarin When using this product do not use more than directed. pain 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 a rash or headache that lasts These could be signs of a serious condition.

If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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. in a child under 12 years of age if you are allergic to acetaminophen 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. liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema taking the blood thinning drug warfarin taking sedatives or tranquilizers avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children pain 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 a rash or headache that lasts These could be signs… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 74 words ▾

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 32 words ▾

Drug Facts Active ingredients (in each caplet) Acetaminophen 500 mg Dextromethorphan HBr 15 mg

Drug facts Active ingredients (in each caplet) Acetaminophen 500 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 15 mg

🧪 Inactive Ingredients 58 words ▾

corn starch, crospovidone, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, mineral oil, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide.

corn starch, crospovidone, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

🎯 Purpose 13 words ▾

Purposes Pain reliever/Fever reducer Cough suppressant

Purposes Pain reliever/Fever reducer Antihistamine Cough suppressant

📄 Do Not Use 180 words ▾

in a child under 12 years of age if you are allergic to acetaminophen 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.

in a child under 12 years of age if you are allergic to acetaminophen 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 75 words ▾

liver disease a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

taking the blood thinning drug warfarin

taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 40 words ▾

When using this product do not use more than directed.

avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

📄 Stop Use and Ask a Doctor If 96 words ▾

pain 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 a rash or headache that lasts These could be signs of a serious condition.

pain 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 a rash or headache that lasts These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 18 words ▾

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

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

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children.

Keep out of reach of children.

📄 Other Information 27 words ▾

Other information Store in a dry place at 15º - 30°C (59° -86°F).

Other information Store in a dry place at 15° – 30°C (59° – 86°F).

📄 Questions or Comments 2 words ▾

1-800-231-4670

1-800-231-4670

📄 Package Label / Principal Display Panel 81 words ▾

CVS™ NDC 51316-984-03 Compare to Theraflu® Flu Relief Max Strength Daytime & Nighttime active ingredients* Maximum Strength† DAYTIME FLU RELIEF Acetaminophen Pain Reliever, Fever Reducer Dextromethorphan HBr Cough Suppressant Relieves: Fever, Body aches, Headache, Sore throat pain, Cough 20 DAYTIME CAPLETS Maximum Strength† NIGHTTIME FLU RELIEF Acetaminophen Pain Reliever, Fever Reducer Chlorpheniramine Maleate, Antihistamine Dextromethorphan HBr Cough Suppressant Additional Nighttime Relief of: Runny nose 20 NIGHTTIME CAPLETS 40 TOTAL CAPLETS †Maximum Strength per 6 hour dose under OTC monograph.

CVS Label

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, Chlorpheniramine Maleate, Dextromethorphan HBr — the ingredient across all brands.

Top reported reactions

Fatigue350
Nausea339
Pyrexia318
Pain313
Headache304
Dyspnoea283
Confusional State250

Reporter sex

3,261 reports
Male · 36%
Female · 64%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 245 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 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 — 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 CVS Pharmacy, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Pharmacy, 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.
← 51316-0982-01 · CVS 51316-0985-08 · CVS →
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.