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CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief Chlorpheniramine maleate and Dextromethorphan Hydrobromide 2 mg/15mL; 15 mg/15mL Solution, 236 mL — NDC 51316-0752-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief Chlorpheniramine maleate and Dextromethorphan Hydrobromide 2 mg/15mL; 15 mg/15mL Solution, 236 mL — NDC 51316-752-08 (Billing 51316-0752-08)

by CVS PHARMACY · 236 mL in 1 BOTTLE, PLASTIC

This is a package of 236 mL of CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief Chlorpheniramine maleate and Dextromethorphan Hydrobromide 2 mg/15mL; 15 mg/15mL Solution from CVS PHARMACY, marketed since Feb 2023 and currently FDA-listed. It is this product's only package size.

NDC 51316-0752-08
🏷️ FDA NDC (as labeled) 51316-752-08 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51316-752-08
Product NDC 51316-752
11-digit billing NDC 51316075208
RxCUI 1114361
UNII V1Q0O9OJ9Z, 9D2RTI9KYH
UPC 0050428541005
Application # M010
SPL Set ID d66b1a2e-49b6-473b-acec-2694c73ce8b4
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-20
Route ORAL
Dosage form SOLUTION
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1114361
Why two NDCs? The FDA registers this code as 51316-752-08 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51316-0752-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists
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?

CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief is an oral liquid solution marketed as an over-the-counter product under FDA's monograph rules for cold and cough remedies. It contains chlorpheniramine maleate, an antihistamine typically used to reduce sneezing, itching, and runny nose, and dextromethorphan hydrobromide, a cough suppressant commonly used to reduce cough. This product is formulated for nighttime use in children and is intended to address multiple cold and upper respiratory symptoms.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51316-0752-08 You're viewing this Main listing 236 mL in 1 BOTTLE, PLASTIC 2023-02-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief 2 mg/15mL; 15 mg/15mL 49035-0545-08 WAL-MART 236 ml — — FDA listed —
CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief 2 mg/15mL; 15 mg/15mLthis 51316-0752-08 CVS 236 ml — — FDA listed —
Vicks NyQuil Kids BERRY COLD and COUGH plus RUNNY NOSE 2 mg/15mL; 15 mg/15mL 69423-0779-08 The 236 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
Feb 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.

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
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedFeb 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses temporarily relieves cold symptoms: ▪ cough due to minor throat & bronchial irritation ▪ sneezing ▪ runny nose

⏱️ Dosage and Administration 66 words ▾

Directions ▪ take only as directed ▪ do not exceed 4 doses per 24 hrs. ▪ only use the dose cup provided adults & children 12 yrs & over 30 mL every 6 hrs. children 6 to under 12 yrs 15 mL every 6 hrs. children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use

⚠️ Warnings ~1 min read ▾

Warnings 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. ▪ to make a child sleepy Ask a doctor before use if you have ▪ 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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product ▪ 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, & tranquilizers may increase drowsiness Stop use and ask a doctor if ▪ cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache. 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.

📦 Storage and Handling 24 words ▾

Other information ▪ each 15 mL contains: potassium 5 mg, sodium 5 mg ▪ sugar free ▪ aspirin free ▪ store at room temperature

🧪 Active Ingredient 18 words ▾

Active ingredients (in each 15 mL) Purpose Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan HBr 15 mg Cough suppressant

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

🎯 Purpose 18 words ▾

Active ingredients (in each 15 mL) Purpose Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan HBr 15 mg Cough suppressant

📄 Do Not Use 62 words ▾

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. ▪ to make a child sleepy

📄 Ask a Doctor Before Use If 46 words ▾

Ask a doctor before use if you have ▪ 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

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 39 words ▾

When using this product ▪ 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, & tranquilizers may increase drowsiness

📄 Stop Use and Ask a Doctor If 34 words ▾

Stop use and ask a doctor if ▪ cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 23 words ▾

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.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-467-2748

📄 Package Label / Principal Display Panel 102 words ▾

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label Compare to the active ingredients in Children’s Vicks Nyquil™ Cold & Cough* NDC 51316-752-08 Nighttime Childrens Cold & Cough Chlorpheniramine maleate 2 mg, Dextromethorphan HBr 15 mg • Sneezing • Runny Nose • Cough No Added Alcohol, Acetaminophen Free Berry Flavor Naturally and Artificially Flavored 8 FL OZ (236 ml) DISTRIBUTED BY: TAMPER EVIDENT: Do not use if printed shrink band is missing or broken. *This product is not manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks ® Nyquil™ Cold & Cough.

CVS Nighttime Children's cold and cough Berry Flavor

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — 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. 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.
← 51316-0745-04 · CVS 51316-0754-12 · 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.