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CVS Severe Multi-Symptom Cough Cold Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid

by CVS PHARMACY · 1 BOTTLE in 1 CARTON (51316-630-04) / 118 mL in 1 BOTTLE
NDC 51316-0630-04
🏷️ FDA NDC (as labeled) 51316-630-04 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 237 mL 51316-0630-08
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 51316-630-04
Product NDC 51316-630
11-digit billing NDC 51316063004
RxCUI 1116572
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID bb24c298-1d00-4378-8de3-b4056220fa75
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-09
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 51316-630-04 — 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 → 51316-0630-04. 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.

🏭 Manufacturer & labeler

LabelerCVS PHARMACY
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio550 products on file
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.

🩺 Clinical

🧪 What is this product?

CVS Severe Multi-Symptom Cough Cold Flu is an over-the-counter liquid taken by mouth that contains four active ingredients commonly used together for cold and flu symptoms. Acetaminophen is typically used to reduce fever and relieve aches and pain. Dextromethorphan is a cough suppressant commonly used to reduce coughing. Guaifenesin functions as an expectorant, helping to thin mucus so it is easier to clear from the airways. Phenylephrine is a decongestant typically used to help relieve nasal and sinus congestion.

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.

🧪 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 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 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII EE90ONI6FF
    Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
  • UNII 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive ingredients anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

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.

💲 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.
Try another pack size: 237 mL
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
leader tussin cf 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 70000-0623-01 Cardinal 1 bottle $0.024 — Availability likely —
Mucinex Fast-Max Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0015-66 Reckitt 180 ml $0.061 — FDA listed —
Maximum Strength Mucinex Fast-Max Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0527-03 Reckitt 180 ml $0.061 — FDA listed —
Mucinex Childrens Multi-Symptom Cold and Sore Throat 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 63824-0952-17 Reckitt 1 bottle $0.067 — FDA listed —
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 63824-0958-64 Reckitt 1 bottle $0.067 — FDA listed —
Robitussin Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00031-8751-12 Haleon 1 bottle — — FDA listed —
Mucus Relief Maximum StrengthCold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0782-06 Walgreens 177 ml — — FDA listed —
Mucus Relief All in One Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0886-06 Walgreens 177 ml — — FDA listed —
Mucus Relief Cold Flu Sore Throat Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-3361-06 Walgreens 177 ml — — FDA listed —
Cough Cold and Sore Throat Childrens 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 00363-4050-04 Walgreens 1 bottle — — FDA listed —
Walgreen Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-6300-08 WALGREENS 1 bottle — — FDA listed —
Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-8005-45 Walgreen 177 ml — — FDA listed —
Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-9042-45 Walgreen 177 ml — — FDA listed —
Mucus Relief Severe Cold Daytime Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0410-06 TARGET 177 ml — — FDA listed —
Target Maximum Strength Cold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0773-06 TARGET 180 ml — — FDA listed —
tussin severe cough cold flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11822-1400-00 Rite 1 bottle — — Discontinued —
Cold Flu and Sore Throat Relief Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0036-06 Safeway, 177 ml — — FDA listed —
COLD, FLU and SORE THROAT RELIEF 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0909-03 BETTER 177 ml — — FDA listed —
Complete Cold Relief 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 27854-0299-00 Belmora 177 ml — — FDA listed —
Maximum Strength Cold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 30142-0731-06 KROGER 180 ml — — FDA listed —
MAX Cold, Flu, and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 37808-0316-25 H 117 ml — — FDA listed —
Mucus Relief Cough Cold Sore Throat 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 37808-0811-40 H 1 bottle — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0035-06 United 177 ml — — FDA listed —
Maximum Strength Mucus Relief Cold,Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0737-06 SUPERVALU 180 ml — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0336-06 EQUATE 177 ml — — FDA listed —
Maximum Strength Mucus Relief Cold,Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0771-09 Wal-Mart 266 ml — — FDA listed —
Tukol Max Action Cold, Flu and Sore Throat 32.5 mg/mL; 1 mg/mL; 20 mg/mL; .5 mg/mL 50066-0313-06 Genomma 1 bottle — — FDA listed —
Tukol MAX ACTION Cold, Sore Throat and Cough 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50066-0516-25 Genomma 177 ml — — FDA listed —
Childrens Tukol Multi-Symptom Cold and Flu 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 50066-0519-24 Genomma 118 ml — — FDA listed —
severe tussin cf 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 51316-0323-26 CVS 1 bottle — — FDA listed —
CVS Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mLthis 51316-0630-04 CVS 1 bottle — — FDA listed —
Tussnex FM Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53041-0618-58 Guardian 177 ml — — FDA listed —
Mucosan Max with Acetaminophen 650 mg/20mL; 400 mg/20mL; 20 mg/20mL; 10 mg/20mL 53145-0696-06 Menper 1 bottle — — FDA listed —
Cold, Flu and Sore Throat Maxium Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53942-0516-25 DeMoulas 177 ml — — FDA listed —
Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55319-0705-45 Family 177 ml — — FDA listed —
SanaTos X Children 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 55758-0443-04 Pharmadel 1 bottle — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0336-09 Dolgencorp, 266 ml — — FDA listed —
dg health tussin 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0398-26 Dolgencorp 1 bottle — — FDA listed —
Mucus Relief All in One Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0886-06 Dolgencorp, 177 ml — — FDA listed —
tussin severe 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 59640-0010-26 H 1 bottle — — FDA listed —
Maximum Strength Mucinex Fast-Max Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0548-64 Reckitt 1 bottle — — FDA listed —
Mucinex Childrens Cold and Flu 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 63824-0954-04 Reckitt 1 bottle — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63868-0746-07 QUALITY 177 ml — — FDA listed —
WINCO Maximum StrengthCold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 67091-0457-06 WINCO 180 ml — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 68163-0737-09 Raritan 266 ml — — FDA listed —
Multi-Symptom Cold and Fever Childrens 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 69842-0475-36 CVS 1 bottle — — FDA listed —
CVS Maximum Strength Cold and Flu Relief 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0566-06 CVS 180 ml — — FDA listed —
CVS Maximum Strength Cold and Flu Relief 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0903-06 CVS 180 ml — — FDA listed —
basic care tussin cf severe 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 72288-0463-34 Amazon.com 1 bottle — — FDA listed —
Mucinex Fast-Max Kickstart Severe Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 72854-0138-66 RB 180 ml — — FDA listed —
topcare tussin cf max 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0000-26 Topco 1 bottle — — FDA listed —
Mucus Relief Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0050-45 TOPCO 177 ml — — FDA listed —
Meijer Adult Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 79481-6300-08 MEIJER 1 bottle — — FDA listed —
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL; 10 mg/20mL; 650 mg/20mL 83324-0143-06 Chain 177 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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51316-0630-04 You're viewing this 1 BOTTLE in 1 CARTON (51316-630-04) / 118 mL in 1 BOTTLE 2023-01-09 Active
51316-0630-08 1 BOTTLE in 1 CARTON (51316-630-08) / 237 mL in 1 BOTTLE 2023-01-09 Active

Pack size FAQ

What quantity is in NDC 51316-0630-04?
NDC 51316-0630-04 is listed by the FDA — 1 bottle in 1 carton / 118 ml in 1 bottle.
What NDC number is used to bill for this package of CVS Severe Multi-Symptom Cough Cold Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid?
Bill NDC 51316-0630-04 — the 11-digit billing format is 51316063004. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) ✓ 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 FDA registers it as 51316-630-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51316-0630-04, written without dashes as 51316063004. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51316-0630-04, the first segment (51316) is the labeler code FDA assigned to CVS PHARMACY; the middle segment (0630) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
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. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (51316-0630-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CVS PHARMACY 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.

📄 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 61 words ▾

Uses ▪ temporarily relieves these symptoms occurring with a cold or flu: ▪ cough due to minor throat and bronchial irritation ▪ nasal congestion ▪ sinus congestion and pressure ▪ minor aches and pains ▪ sore throat ▪ headache ▪ temporarily reduces fever ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

⏱️ Dosage and Administration 85 words ▾

Directions ▪ do not take more than 6 doses in any 24-hour period ▪ do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ ml = milliliter ▪ this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 ml every 4 hours children under 12 years do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 6 doses in any 24-hour period, which is the maximum daily amount ▪ 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 ▪ 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. ▪ with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking any other oral nasal decongestant or stimulant ▪ taking any other pain reliever/fever reducer When using this product do not use more than directed Stop use and ask a doctor if ▪ you get nervous, dizzy, or sleepless ▪ pain, cough, or nasal congestion 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 at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

📦 Storage and Handling 18 words ▾

Other information • each 20 ml contains: sodium 7 mg • store at room temperature. Do not refrigerate.

🧪 Active Ingredient 24 words ▾

Active ingredients (in each 20 ml) Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCl, USP 10 mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

🎯 Purpose 9 words ▾

Purposes Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51316-0627-09 · CVS 51316-0631-08 · 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.