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VICKS CHILDRENS COUGH CONGESTION Dextromethorphan Hydrobromide, Diphenhydramine HCl, Guaifenesin, Phenylephrine Hydrochloride Kit — NDC 69423-0997-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

VICKS CHILDRENS COUGH CONGESTION Dextromethorphan Hydrobromide, Diphenhydramine HCl, Guaifenesin, Phenylephrine Hydrochloride Kit — NDC 69423-997-12 (Billing 69423-0997-12)

by The Procter & Gamble Manufacturing Company · 1 KIT in 1 PACKAGE * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC

This is a package of VICKS CHILDRENS COUGH CONGESTION Dextromethorphan Hydrobromide, Diphenhydramine HCl, Guaifenesin, Phenylephrine Hydrochloride Kit from The Procter & Gamble Manufacturing Company, marketed since Jul 2019 and currently FDA-listed, this package's marketing is listed to end Dec 2026. It is this product's only package size.

NDC 69423-0997-12
🏷️ FDA NDC (as labeled) 69423-997-12 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 69423-997-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69423 labeler · 997 product · 12 package
Package marketed since
Jul 9, 2019
Package marketing ended
Dec 31, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 6942399712 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69423-997-12
Product NDC 69423-997
11-digit billing NDC 69423099712
RxCUI 2166123, 2166129, 2626496, 2626497
Application # M012
SPL Set ID f1d67797-c806-261d-e053-2a95a90a3c15
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-09
Marketing end 2026-12-31
Route ORAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 2166123
Why two NDCs? The FDA registers this code as 69423-997-12 — 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 → 69423-0997-12. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter oral cough and cold kit for children containing four active ingredients. Dextromethorphan and diphenhydramine are typically used to suppress cough, while guaifenesin functions as an expectorant to help thin mucus. Phenylephrine is a nasal decongestant commonly used to reduce congestion. This product is marketed under the FDA's over-the-counter monograph rules for cough and cold medicines.

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 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
69423-0997-12 You're viewing this Main listing 1 KIT in 1 PACKAGE * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC 2019-07-09 Dec 31, 2026 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vicks Childrens Cough Congestionthis 69423-0997-12 The 1 kit — — 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

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color white
FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

From the label’s inactive-ingredient sectionanhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
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

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69423
First marketedJul 2019
Product typeHuman Otc Drug
Portfolio850 products on file

More NDCs from The Procter & Gamble Manufacturing Company labeler code 69423

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 🆘 Overdosage 📦 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 57 words ▾

Uses temporarily relieves common cold symptoms: nasal congestion runny nose & sneezing cough due to minor throat and bronchial irritation

Uses temporarily relieves common cold symptoms: nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

⏱️ Dosage and Administration 121 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 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use

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 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

⚠️ Warnings ~2 min read ▾

Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy 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 heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to 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, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a 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.

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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema a sodium-restricted diet When using this product, do not use more than directed.

Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a 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.

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 31 words ▾

Other information each 15 mL contains: sodium 44 mg Store at no greater than 25ºC.

Other information each 15 mL contains : sodium 44 mg store at no greater than 25ºC

🧪 Active Ingredient 42 words ▾

Active ingredients (in each 15 mL) Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg Purpose Antihistamine/Cough suppressant Nasal decongestant

Active ingredients (in each 15 mL) Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg Purpose Cough suppressant Expectorant Nasal decongestant

🧪 Inactive Ingredients 46 words ▾

Inactive ingredients anhydrous citric acid, flavor, glycerin, polysorbate 20, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Inactive ingredients anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

🎯 Purpose 11 words ▾

Purpose Antihistamine/Cough suppressant Nasal decongestant

Purpose Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 55 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.

📄 Ask a Doctor Before Use If 99 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to 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, or emphysema a sodium-restricted diet

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema a sodium-restricted diet

📄 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 50 words ▾

When using this product do not use more than directed. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

When using this product, do not use more than directed.

📄 Stop Use and Ask a Doctor If 102 words ▾

Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not improve within 7 days or occur with a fever cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 20 words ▾

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

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

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach of children.

Keep out of reach of children.

📄 Questions or Comments 4 words ▾

Questions? 1-800-362-1683

Questions? 1-800-362-1683

📄 Package Label / Principal Display Panel 97 words ▾

PRINCIPAL DISPLAY PANEL - Kit Carton DAY & NIGHT PACK children's Cough Congestion Phenylephrine HCl - nasal decongestant Dextromethorphan HBr - cough suppressant Guaifenesin - expectorant Non-Drowsy FREE of: Artificial Dyes & Flavors, High Fructose Corn Syrup & Alcohol Cough Chest congestion Stuffy nose Ages 4+ children's Cough Congestion Night Phenylephrine HCl - nasal decongestant Diphenhydramine HCl - antihistamine/cough suppressant Nighttime FREE of: Artificial Dyes & Flavors, High Fructose Corn Syrup & Alcohol Cough Runny nose Stuffy nose Sneezing Ages 6+ 2 BOTTLES - 6 FL OZ (177 mL) EACH; TOTAL 12 FL OZ (354 mL) 997.jpg

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 VICKS CHILDRENS COUGH CONGESTION (this brand).

Top reported reactions

Death1

Reporter sex

1 reports

Serious outcomes

Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 it is currently marketed — but The Procter & Gamble Manufacturing Company has reported a marketing end date of 2026-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Procter & Gamble Manufacturing Company 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.
← 69423-0996-12 · The 69423-0999-08 · The →
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.