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(from DailyMed)

Basic Care Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride 500 mg; 20 mg; 10 mg Powder, For Solution, 6-count

by Amazon.com Services LLC · 6 POWDER, FOR SOLUTION in 1 CARTON (72288-303-91)
NDC 72288-0303-91
🏷️ FDA NDC (as labeled) 72288-303-91 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 72288-303-91
Product NDC 72288-303
11-digit billing NDC 72288030391
RxCUI 1189316
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 968c605e-fea3-4c79-b650-6021aa17db7a
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2021-08-11
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 72288-303-91 — 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 → 72288-0303-91. 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

LabelerAmazon.com Services LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code72288
First marketedAug 2021
Product typeHuman Otc Drug
Portfolio331 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?

This is an over-the-counter powder product designed to be mixed with water and taken by mouth to address multiple cold and flu symptoms. It contains acetaminophen, which is typically used to reduce fever and relieve aches and pains, along with dextromethorphan, a cough suppressant commonly used to reduce coughing. The product also includes phenylephrine, a decongestant typically used to help relieve nasal congestion. As an OTC monograph drug, it is marketed under established FDA guidelines for this category of multi-symptom cold and flu products.

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.

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.

💲 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
Theraflu Multi-Symptom Severe Cold 500 mg/237mL; 20 mg/237mL; 10 mg/237mL 00067-6426-06 Haleon 6 packets FDA listed
THERAFLU Severe Cold Relief Daytime 500 mg/237mL; 20 mg/237mL; 10 mg/237mL 00067-6802-02 Haleon 6 packets FDA listed
Multi Symptom Wal Flu Severe Cold 500 mg/1; 20 mg/1; 10 mg 00363-5470-06 WALGREEN 6 powders FDA listed
Equate Severe Cold Multi Symptom 500 mg/1; 20 mg/1; 10 mg 49035-0907-91 Wal-Mart 6 powders FDA listed
Dg Health Multi Symptom Severe Cold 500 mg/1; 20 mg/1; 10 mg 55910-0509-91 Dolgencorp, 6 powders FDA listed
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 500 mg/5g; 10 mg/5g; 20 mg/5g 58933-0550-01 Procter 5 g FDA listed
Multi Symptom Severe Cold 500 mg/1; 20 mg/1; 10 mg 68163-0547-06 RARITAN 6 powders FDA listed
Basic Care Severe Cold and Flu 500 mg/1; 20 mg/1; 10 mgthis 72288-0303-91 Amazon.com 6 powders Discontinued
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

🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 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, Phenylephrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Choking25
Foreign Body In Respiratory Tract10
Foreign Body In Throat8
Fatigue7
Covid-196
Anxiety5
Insomnia5

Age at onset

Adult18
Elderly8

Reporter sex

93 reports
Male · 30%
Female · 70%

Serious outcomes

Hospitalization11
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 27 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
72288-0303-91 You're viewing this 6 POWDER, FOR SOLUTION in 1 CARTON (72288-303-91) 2021-08-11 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 72288-303-91, 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: 72288-0303-91, written without dashes as 72288030391. 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 72288-0303-91, the first segment (72288) is the labeler code FDA assigned to Amazon.com Services LLC; the middle segment (0303) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (91) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Amazon.com Services LLC 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 33 words

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever

⏱️ Dosage and Administration 97 words

Directions do not use more than directed (see overdose warning) take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water: sip while hot.

Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

⚠️ Warnings ~1 min read

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use in a child under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients 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 trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

📦 Storage and Handling 33 words

Other information each packet contains: potassium 10 mg and sodium 25 mg phenylketonurics: contains phenylalanine 22 mg per packet store at 20-25 ° C (68-77 ° F). Protect product from heat and moisture.

🧪 Active Ingredient 16 words

Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 30 words

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

🎯 Purpose 8 words

Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant

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