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Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE 325 mg; 2 mg; 7.8 mg Tablet, Effervescent — NDC 00280-1400-32 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE 325 mg; 2 mg; 7.8 mg Tablet, Effervescent — NDC 0280-1400-32 (Billing 00280-1400-32)

by Bayer HealthCare LLC. · 16 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH

This is a package of Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE 325 mg; 2 mg; 7.8 mg Tablet, Effervescent from Bayer HealthCare LLC., marketed since Apr 2008 and currently FDA-listed. It is this product's only package size.

NDC 00280-1400-32
🏷️ FDA NDC (as labeled) 0280-1400-32 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 0280-1400-32 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0280 labeler · 1400 product · 32 package
Package marketed since
Apr 10, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0280140032 5
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-1400-32
Product NDC 0280-1400
11-digit billing NDC 00280140032
RxCUI 1536840
UNII R16CO5Y76E, V1Q0O9OJ9Z, 27O3Q5ML57
Application # M013
SPL Set ID 78537dcf-b157-4b67-a8b2-5cb144815166
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-04-10
Route ORAL
Dosage form TABLET, EFFERVESCENT
Substance ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
Quick answers
  • RxCUI (RxNorm): 1536840
Why two NDCs? The FDA registers this code as 0280-1400-32 — 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 → 00280-1400-32. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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?

This is an over-the-counter effervescent tablet containing aspirin, chlorpheniramine maleate, and phenylephrine bitartrate. Aspirin is typically used to reduce pain and fever, while chlorpheniramine maleate is an antihistamine commonly used to relieve allergy and cold symptoms such as sneezing and runny nose. Phenylephrine bitartrate functions as a nasal decongestant to help relieve stuffy nose. The tablet dissolves in water and is taken by mouth.

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
00280-1400-32 You're viewing this Main listing 16 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH 2008-04-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest 7 mg/1; 2 mg/1; 325 mg 00280-0020-01 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz 325 mg/1; 2 mg/1; 7.8 mg 00280-0060-01 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Medicine Sparkling Original 325 mg/1; 2 mg/1; 7.8 mgthis 00280-1400-32 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Orange Zest 325 mg/1; 2 mg/1; 7.8 mg 00280-1510-20 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Sparkling Original 325 mg/1; 7.8 mg/1; 2 mg 00280-1520-04 Bayer 2 tablets — — FDA listed —
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve 325 mg/1; 2 mg/1; 7.8 mg 00280-8270-16 Bayer 2 tablets — — FDA listed —
Walgreens Effervescent Cold Relief Plus 325 mg/1; 2 mg/1; 7.8 mg 00363-0875-36 Walgreens 2 tablets — — FDA listed —
Kroger Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 30142-0875-36 Kroger 2 tablets — — FDA listed —
Effervescent Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 36800-0768-20 Topco 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 37808-0768-20 H. 2 tablets — — FDA listed —
Equaline Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 41163-0768-20 United 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 41250-0123-20 Meijer 2 tablets — — FDA listed —
Meijer Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 41250-0768-36 Meijer 2 tablets — — FDA listed —
Equate Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 49035-0768-67 Walmart 2 tablets — — FDA listed —
Top Value Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 50201-7682-02 Tower 2 tablets — — FDA listed —
Top Value Effervescent Cold Relief - Orange 7.8 mg/1; 325 mg/1; 2 mg 50201-8752-00 Tower 2 tablets — — FDA listed —
Good Sense Effervescent Cold Relief 2 mg/1; 325 mg/1; 7.8 mg 50804-0873-20 Good 2 tablets — — FDA listed —
Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 53943-0873-20 Discount 2 tablets — — FDA listed —
Family Wellness Effervescent Cold Relief Orange 2 mg/1; 325 mg/1; 7.8 mg 55319-0875-20 Family 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 55910-0769-20 DOLGENCORP, 2 tablets — — FDA listed —
Dollar General Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 55910-0873-20 DOLGENCORP, 2 tablets — — FDA listed —
Quality Choice Effervescent Cold Relief Plus 325 mg/1; 2 mg/1; 7.8 mg 63868-0228-20 Chain 2 tablets — — FDA listed —
Quality Choice Effervescent Cold Relief - Orange 7.8 mg/1; 325 mg/1; 2 mg 63868-0568-20 Chain 2 tablets — — FDA listed —
Best Choice Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 63941-0873-20 Valu 2 tablets — — FDA listed —
WinCo Foods Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 67091-0109-20 WinCo 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 69842-0875-20 CVS 2 tablets — — 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

🏛️
2008
On the market since
Apr 2008
📍
2026
Currently FDA-listed
18 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
ShapeRound
ImprintALKA;SELTZER;PLUS
Size25 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII S4255P4G5M
    Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.

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

The official label also statesacesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBayer HealthCare LLC.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedApr 2008
Product typeHuman Otc Drug
Portfolio240 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. 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 12 words ▾

Uses temporarily relieves these symptoms due to a cold: temporarily reduces fever

⏱️ Dosage and Administration 42 words ▾

Directions adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use

⚠️ Warnings ~3 min read ▾

Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed 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 if you are allergic to aspirin or any other pain reliever/fever reducer 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 stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma diabetes thyroid disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction occurs.

Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain 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 ringing in the ears or a loss of hearing occurs nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

📦 Storage and Handling 22 words ▾

Other information each tablet contains: sodium 474 mg Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet store at room temperature. Avoid excessive heat.

🧪 Active Ingredient 27 words ▾

Active ingredients (in each tablet) Purposes Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine bitartrate 7.8 mg Nasal decongestant

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

🎯 Purpose 27 words ▾

Active ingredients (in each tablet) Purposes Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Phenylephrine bitartrate 7.8 mg Nasal decongestant

📄 Do Not Use 96 words ▾

Do not use to sedate children. Do not use if you are allergic to aspirin or any other pain reliever/fever reducer 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 68 words ▾

Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma diabetes thyroid disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis a sodium-restricted diet

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis taking sedatives or tranquilizers

📄 When Using This Product 39 words ▾

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

📄 Stop Use and Ask a Doctor If 87 words ▾

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain 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 ringing in the ears or a loss of hearing occurs nervousness, dizziness, or sleeplessness occurs

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Questions or Comments 9 words ▾

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

📄 Package Label / Principal Display Panel 57 words ▾

PRINCIPAL DISPLAY PANEL - 36 Tablet Carton Alka- Seltzer PLUS ® Aspirin (NSAID) / Pain reliever- fever reducer • Chlorpheniramine maleate / Antihistamine • Phenylephrine bitartrate / Nasal decongestant COLD FORMULA SPARKLING ORIGINAL Nasal Congestion • Runny Nose Headache & Body Ache Sore Throat • Sinus Pressure 36 EFFERVESCENT TABLETS Principal Display Panel - 36 Tablet Carton

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) ✓ 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.
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.
← 00280-1235-05 · Bayer 00280-1410-32 · 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.