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ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride Kit — NDC 00280-8286-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride Kit — NDC 0280-8286-24 (Billing 00280-8286-24)

by Bayer HealthCare, LLC. · 1 KIT in 1 CARTON * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride Kit from Bayer HealthCare, LLC., marketed since Jun 2026 and currently FDA-listed.

NDC 00280-8286-24
🏷️ FDA NDC (as labeled) 0280-8286-24 billing pads the labeler segment with a zero
This package
Contains1 kit in 1 carton * 1 capsule, liquid filled in 1 blister pack * 2 capsule, liquid filled in 1 blister pack * 1 capsule, liquid filled in 1 blister pack * 1 capsule, liquid filled in 1 blister pack Pack sizes2 compare ↓
Product page 00280-8286-16 Also comes in: 1 capsule 0280-8286-16
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0280-8286-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0280 labeler · 8286 product · 24 package
Package marketed since
Jun 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0016500584223
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-8286-24
Product NDC 0280-8286
11-digit billing NDC 00280828624
RxCUI 1297288, 1656815, 2634364
UPC 0016500584223
Application # M012
SPL Set ID 51a4195b-8776-964c-e063-6294a90aa075
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-01
Route ORAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1297288
Why two NDCs? The FDA registers this code as 0280-8286-24 — a 4-4-2 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 labeler segment → 00280-8286-24. 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.

Clinical

🧪 What is this product?

Alka Seltzer Cold is an oral over-the-counter kit containing fast-acting gels sold under FDA's OTC monograph rules. It combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine (a sleep aid) for daytime and nighttime symptom relief. The kit also includes guaifenesin (an expectorant to help thin mucus) and phenylephrine (a nasal decongestant). This product is intended to address multiple cold symptoms at once.

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.
Try another pack size: 1 capsule
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
00280-8286-16 0280-8286-16 Main listing 1 KIT in 1 CARTON * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2026-06-01 — Active
00280-8286-24 You're viewing this 1 KIT in 1 CARTON * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2026-06-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 carton * 1 capsule, liquid filled in 1 blister pack * 2 capsule, liquid filled in 1 blister pack * 1 capsule, liquid filled in 1 blister pack * 1 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride Kit?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gelsthis 00280-8286-24 Bayer 1 capsule — — FDA listed —
DayQuil and NyQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION 69423-0991-24 The 1 kit — — FDA listed —
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night 00280-0062-01 Bayer 2 capsules — — FDA listed —
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax 00280-0035-01 Bayer 3 capsules — — 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 green / red
ShapeOval
ImprintASP;N
Size16 mm
ScoringNot scored
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 sectionInactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

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

LabelerBayer HealthCare, LLC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Bayer HealthCare, LLC. labeler code 00280

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 📄 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 101 words ▾

Uses Uses · helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Uses Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · nasal congestion · sinus congestion and pressure · cough · sore throat · runny nose · sneezing · temporarily reduces fever

⏱️ Dosage and Administration 96 words ▾

Directions Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use

Directions Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use

⚠️ Warnings ~3 min read ▾

Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 10 capsules 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 or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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 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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age Ask a doctor before use if you have Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● cough is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ● difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dosage Stop use and ask a doctor if Stop use and ask a doctor if · 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 fever, rash or headache that lasts.

These could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 10 capsules 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 or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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 to sedate children. Do not use 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 presc… [Excerpted — this section continues on DailyMed.]

🧪 Active Ingredient 55 words ▾

Active ingredients Active ingredients (in each capsule) Purposes Acetaminophen 325 mg…………….……….Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg…………..Cough suppressant Guaifenesin 200 mg…………………………………………..Expectorant Phenylephrine hydrochloride 5 mg………………...Nasal decongestant

Active ingredients (in each capsule) Purposes Acetaminophen 325 mg…………….… ……...Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg…… ………Cough suppressant Doxylamine succinate 6.25 mg…………… ………………...Antihistamine Phenylephrine hydrochloride 5 mg.....…… ………...Nasal decongestant

🧪 Inactive Ingredients 64 words ▾

Inactive ingredients Inactive ingredients FD&C red No. 40, gelatin, glycerin, lecithin, medium chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Inactive ingredients Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

📄 Do Not Use 218 words ▾

Do not use 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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age

Do not use 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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 12 years of age

📄 Ask a Doctor Before Use If 140 words ▾

Ask a doctor before use if you have Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● cough is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ● difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you have Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● glaucoma ● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 58 words ▾

Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are ● taking the blood thinning drug warfarin ● taking sedatives or tranquilizers

📄 When Using This Product 64 words ▾

When using this product When using this product do not exceed recommended dosage

When using this product When using this product ● do not exceed recommended dosage ● may cause marked drowsiness ● alcohol, sedatives, and tranquilizers may increase the drowsiness effect ● avoid alcoholic drinks ● be careful when driving a motor vehicle or operating machinery ● excitability may occur, especially in children

📄 Stop Use and Ask a Doctor If 149 words ▾

Stop use and ask a doctor if Stop use and ask a doctor if · 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 fever, rash or headache that lasts. These could be signs of a serious condition. · nervousness, dizziness, or sleeplessness occurs

Stop use and ask a doctor if Stop use and ask a doctor if · 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. · nervousness, dizziness, or sleeplessness occurs

🤰 If Pregnant or Breast-Feeding 28 words ▾

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

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

📄 Keep Out of Reach of Children 99 words ▾

Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Other Information 25 words ▾

Other information Other information · store at 15°- 25°C (59° - 77°F)

Other information Other information · store at 15° - 25°C (59° - 77°F)

📄 Questions or Comments 24 words ▾

Questions or comments Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)

Questions or comments Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)

📄 Package Label / Principal Display Panel 3 words ▾

Package label PDP

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 Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Expired Product Administered1
Foreign Body In Throat1
Odynophagia1
Product Physical Consistency Issue1

Age at onset

Adult1

Reporter sex

1 reports
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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: this package is listed as actively marketed, with no marketing end date reported by Bayer HealthCare, LLC.. 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 capsule (00280-8286-16). 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?
Bayer HealthCare, 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.
← 00280-8285-24 · Bayer 00280-8287-24 · Bayer →
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.