Home › NDC Lookup › Ingredients › Acetaminophen Dextromethorphan Hydrobrom... › 51316-0641-12
🧴image loading
(from DailyMed)

CVS NightTime Cold acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL Solution, 354 mL

by CVS PHARMACY · 354 mL in 1 BOTTLE, PLASTIC (51316-641-12)
NDC 51316-0641-12
🏷️ FDA NDC (as labeled) 51316-641-12 billing pads the product segment with a zero
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) 51316-641-12
Product NDC 51316-641
11-digit billing NDC 51316064112
RxCUI 1431245
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
Application # M010
SPL Set ID 0f0cc40d-7939-4d4d-a931-b4de4070fea1
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Receptor Antagonists [MoA
Mechanism of action Adrenergic alpha1-Agonists; Histamine Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-09
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 51316-641-12 — 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 → 51316-0641-12. 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 applicationM010 (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 NightTime Cold is an oral liquid solution sold over the counter under FDA's OTC monograph rules. It contains acetaminophen, which is typically used to reduce fever and relieve pain; dextromethorphan, which is commonly used to suppress cough; doxylamine, which functions as a sleep aid; and phenylephrine, which is typically used as a nasal decongestant. This combination is formulated for nighttime symptom relief during cold and flu illness.

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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

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

The official label also statescitric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

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.
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
Good Sense Severe NightTime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00113-0019-40 L. 354 ml $0.010 — Availability likely —
foster and thrive nighttime severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 70677-1030-01 Strategic 355 ml $0.013 — FDA listed —
Good Sense Severe NightTime Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00113-0763-34 L. 237 ml — — Discontinued —
good sense night time cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 00113-2501-40 L. 354 ml — — FDA listed —
Night Time Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-0331-26 Walgreen 237 ml — — FDA listed —
severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-0623-40 Walgreen 355 ml — — FDA listed —
Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-0763-40 Walgreen 355 ml — — FDA listed —
nighttime severe cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 00363-2029-40 Walgreen 355 ml — — FDA listed —
Walgreen NightTime Cold and Flu relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 00363-6142-12 WALGREENS 354 ml — — FDA listed —
Nighttime Severe Honey Cold and Flu 6.25 mg/15mL; 325 mg/15mL; 10 mg/15mL; 5 mg/15mL 11673-0322-01 TARGET 354 ml — — FDA listed —
Nighttime severe cold and flu 20 mg/30mL; 650 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 11673-0828-01 TARGET 354 ml — — FDA listed —
nighttime severe cold and flu relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 11822-0511-01 Rite 355 ml — — FDA listed —
severe cold and flu relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 11822-0763-01 Rite 355 ml — — FDA listed —
severe cold and flu relief 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 11822-4099-00 Rite 355 ml — — FDA listed —
Signature Care Nighttime Severe Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 21130-0129-40 Safeway 355 ml — — FDA listed —
NightTime Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 30142-0763-40 Kroger 354 ml — — FDA listed —
topcare nite time cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 36800-0291-40 Topco 355 ml — — FDA listed —
Vicks NyQuil Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 37000-0812-01 The 30 ml — — FDA listed —
Vicks NyQuil Severe Cold and Flu 10 mg/30mL; 12.5 mg/30mL; 20 mg/30mL; 650 mg/30mL 37000-0815-08 The 236 ml — — FDA listed —
nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 37808-0763-40 H 355 ml — — FDA listed —
equaline nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41163-0763-40 United 355 ml — — FDA listed —
Severe Cold and Flu Nighttime Honey 10 mg/15mL; 5 mg/15mL; 6.25 mg/15mL; 325 mg/15mL 41226-0767-01 Kroger 354 ml — — FDA listed —
Nighttime Severe Cold and Flu 12.5 mg/30mL; 10 mg/30mL; 650 mg/30mL; 20 mg/30mL 41226-0775-01 Kroger 354 ml — — FDA listed —
Nitetime Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41250-0763-40 Meijer 355 ml — — FDA listed —
nitetime cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41250-0811-40 Meijer 355 ml — — FDA listed —
CareOne Nighttime Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 41520-0561-40 American 355 ml — — FDA listed —
Severe Cold and Flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 42507-0020-40 HyVee 355 ml — — FDA listed —
Severe Cold and Flu Night time 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 42507-0763-40 HyVee 355 ml — — FDA listed —
severe cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 42507-0861-40 HyVee 355 ml — — FDA listed —
equate nighttime cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 49035-0807-40 Wal-Mart 355 ml — — FDA listed —
Severe cold and flu Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 49580-0416-08 P 237 ml — — FDA listed —
Severe cold and flu Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 49580-4160-08 P 237 ml — — FDA listed —
Tylenol Cold plus Flu plus Cough Night 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 50580-0369-01 Kenvue 240 ml — — FDA listed —
nighttime severe 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 51316-0179-40 CVS 355 ml — — FDA listed —
Severe Cold And Flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 51316-0533-40 CVS 355 ml — — FDA listed —
CVS NightTime Cold 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mLthis 51316-0641-12 CVS 354 ml — — FDA listed —
Severe Nighttime Cold and Flu Relief 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 55319-0641-08 Family 237 ml — — FDA listed —
Severe cold and flu Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 55910-0716-08 Dolgencorp, 237 ml — — FDA listed —
dg health cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 55910-0900-34 Dolgencorp, 237 ml — — FDA listed —
DG Health Cold and Flu Severe 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 55910-0928-40 Dolgencorp 355 ml — — FDA listed —
nitetime severe 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 56062-0763-40 Publix 355 ml — — FDA listed —
Rompe Pecho Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 58593-0830-06 EFFICIENT 1 bottle — — FDA listed —
Nighttime SEVERE 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 59640-0423-40 H 355 ml — — FDA listed —
Severe Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 59779-0763-34 CVS 237 ml — — Discontinued —
VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU 325 mg/15mL; 5 mg/15mL; 10 mg/15mL; 6.25 mg/15mL 69423-0807-08 Procter 236 ml — — FDA listed —
Vicks NyQuil Severe Honey Cold and Flu 325 mg/15mL; 5 mg/15mL; 10 mg/15mL; 6.25 mg/15mL 69423-0968-08 Procter 236 ml — — FDA listed —
NyQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION 10 mg/30mL; 12.5 mg/30mL; 20 mg/30mL; 650 mg/30mL 69423-0989-08 The 236 ml — — FDA listed —
Nighttime Severe 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 69842-0800-40 CVS 355 ml — — FDA listed —
basic care nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 72288-0189-40 Amazon.com 355 ml — — FDA listed —
basic care nighttime severe cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 72288-0601-40 Amazon.com 355 ml — — FDA listed —
basic care nighttime severe cold and flu 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 72288-0639-40 Amazon.com 355 ml — — FDA listed —
topcare nite time cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 76162-0202-40 Topco 355 ml — — FDA listed —
night time cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 79481-8999-00 Meijer, 355 ml — — FDA listed —
equate nighttime cold and flu 325 mg/15mL; 10 mg/15mL; 6.25 mg/15mL; 5 mg/15mL 79903-0122-12 WALMART 1 bottle — — FDA listed —
Cold and Flu plus Congestion Nighttime 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL 79903-0191-12 WALMART 355 ml — — FDA listed —
Nighttime Severe Cold and Flu 12.5 mg/30mL; 10 mg/30mL; 650 mg/30mL; 20 mg/30mL 85828-0775-01 Grocery 354 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Covid-19173
Disease Recurrence134
Nasopharyngitis131
Fatigue110
Cough102
Nausea100
Diarrhoea86

Age at onset

Child2
Adolescent8
Adult194
Elderly69

Reporter sex

1,461 reports
Male · 36%
Female · 64%

Serious outcomes

Hospitalization296
Death55
Life-threatening54
Disabling27
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 109 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51316-0641-12 You're viewing this 354 mL in 1 BOTTLE, PLASTIC (51316-641-12) 2023-01-09 Active

🧭 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 51316-641-12, 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: 51316-0641-12, written without dashes as 51316064112. 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 51316-0641-12, the first segment (51316) is the labeler code FDA assigned to CVS PHARMACY; the middle segment (0641) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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.
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 66 words ▾

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

⏱️ Dosage and Administration 50 words ▾

Directions • take only as directed • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses in 24 hours, which is the maximum daily amount for this product • 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 • glaucoma • 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 • trouble urinating due to enlarged prostate gland • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • you get nervous, dizzy or sleepless • 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 at 1-800-222-1222 . Quick 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 30 mL contains: sodium 81 mg • Store at room temperature. Do not refrigerate.

🧪 Active Ingredient 23 words ▾

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

🎯 Purpose 8 words ▾

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51316-0639-66 · CVS 51316-0643-04 · 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.