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Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride 325 mg; 10 mg; 5 mg Capsule, Liquid Filled — NDC 00280-0095-02 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 Maximum Strength Sinus, Congestion and Pain Power Max Gels Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride 325 mg; 10 mg; 5 mg Capsule, Liquid Filled — NDC 0280-0095-02 (Billing 00280-0095-02)

by Bayer HealthCare LLC. · 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride 325 mg; 10 mg; 5 mg Capsule, Liquid Filled from Bayer HealthCare LLC., marketed since Aug 2021 and currently FDA-listed.

NDC 00280-0095-02
🏷️ FDA NDC (as labeled) 0280-0095-02 billing pads the labeler segment with a zero
This package
Contains12 capsule, liquid filled in 1 blister pack Pack sizes2 compare ↓
Product page 00280-0095-01 Also comes in: 8 capsules 0280-0095-01
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 0280-0095-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0280 labeler · 0095 product · 02 package
Package marketed since
Aug 25, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0016500583493
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-0095-02
Product NDC 0280-0095
11-digit billing NDC 00280009502
RxCUI 1086997
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
UPC 0016500583493
Application # M012
SPL Set ID e07931fc-f753-1aeb-e053-2a95a90ada3f
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 On market
FDA listing status Listed (active directory)
Marketing start 2021-08-01
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1086997
Why two NDCs? The FDA registers this code as 0280-0095-02 — 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 → 00280-0095-02. 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

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

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

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

This is an over-the-counter oral capsule that combines three active ingredients commonly used to manage cold and sinus symptoms. Acetaminophen is typically used to reduce fever and relieve pain, while dextromethorphan is commonly included to suppress cough. Phenylephrine hydrochloride functions as a nasal decongestant intended to help relieve sinus congestion. This product is marketed under FDA's OTC monograph rules, which govern combinations of these types of symptom-relief ingredients.

Supplement & herbal interactions

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

Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 8 capsules
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
00280-0095-01 0280-0095-01 Main listing 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2021-08-25 — Active
00280-0095-02 You're viewing this 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2021-08-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride 325 mg; 10 mg; 5 mg Capsule, Liquid Filled?
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
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 00904-6995-44 Major 1 capsule $0.131 — Availability likely —
good neighbor pharmacy day time cold and flu 325 mg/1; 10 mg/1; 5 mg 24385-0036-62 Amerisource 2 capsules $0.131 — Availability likely —
Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 70000-0515-01 CARDINAL 1 capsule $0.131 — Availability likely —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 70000-0752-01 CARDINAL 1 capsule $0.131 — Availability likely —
good sense daytime 325 mg/1; 10 mg/1; 5 mg 00113-0994-51 L. 2 capsules $0.138 — Discontinued —
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels 325 mg/1; 10 mg/1; 5 mgthis 00280-0095-02 Bayer 12 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day Cold and Flu 325 mg/1; 10 mg/1; 5 mg 00280-1590-20 Bayer 10 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels 10 mg/1; 5 mg/1; 325 mg 00280-1630-16 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels 10 mg/1; 5 mg/1; 325 mg 00280-8275-24 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels 325 mg/1; 10 mg/1; 5 mg 00280-8281-24 Bayer 8 capsules — — FDA listed —
Daytime Cold and Flu 5 mg/1; 10 mg/1; 325 mg 00363-0853-16 WALGREENS 8 capsules — — FDA listed —
Daytime Non-Drowsy Cold and Flu 325 mg/1; 10 mg/1; 5 mg 00363-8998-16 Walgreens 8 capsules — — FDA listed —
Maximum Strength Congestion and Headache 325 mg/1; 10 mg/1; 5 mg 00363-9019-16 Walgreens 8 capsules — — FDA listed —
Daytime Ultra Concentrated Cold and Flu 5 mg/1; 325 mg/1; 10 mg 11673-0843-48 TARGET 48 capsules — — FDA listed —
Daytime Cold And Flu Multi Symptom 10 mg/1; 325 mg/1; 5 mg 11673-0975-24 TARGET 12 capsules — — FDA listed —
Multi-Symptom Cold And Flu Relief Daytime 5 mg/1; 325 mg/1; 10 mg 11822-1989-00 RITE 12 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 11822-3391-08 Rite 1 capsule — — FDA listed —
Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 21130-0598-24 Safeway, 1 capsule — — FDA listed —
Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 21130-0650-24 Safeway, 1 capsule — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 21130-0900-24 BETTER 12 capsules — — FDA listed —
Kroger Daytime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 30142-0087-48 The 12 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 35916-0155-01 SOFTGEL 12 capsules — — FDA listed —
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 5 mg/1; 10 mg/1; 325 mg 35916-0188-01 Softgel 1000 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 35916-0917-01 SOFTGEL 3000 capsules — — FDA listed —
Daytime 5 mg/1; 325 mg/1; 10 mg 37808-0093-16 H-E-B 8 capsules — — FDA listed —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 37808-0848-16 H 1 capsule — — FDA listed —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 37808-0864-16 H 1 capsule — — FDA listed —
day time 325 mg/1; 10 mg/1; 5 mg 37808-0994-60 H 2 capsules — — Discontinued —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 37835-0520-24 Bi-Mart 24 capsules — — FDA listed —
Daytime Cold and Flu Relief Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 41163-0848-24 United 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 41163-0998-24 United 1 capsule — — FDA listed —
Daytime Cold And Flu 10 mg/1; 5 mg/1; 325 mg 41226-0693-24 Kroger 12 capsules — — FDA listed —
Multi-Symptom Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 41520-0068-24 Care 1 capsule — — Discontinued —
cold and flu 325 mg/1; 10 mg/1; 5 mg 42507-0700-62 HyVee 2 capsules — — FDA listed —
Cold and Flu Daytime 325 mg/1; 10 mg/1; 5 mg 49035-0193-24 EQUATE 1 capsule — — FDA listed —
Daytime cold and flu 5 mg/1; 325 mg/1; 10 mg 49483-0693-48 TIME 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 51316-0896-24 CVS 1 capsule — — FDA listed —
DayTime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 53345-0004-01 Humanwell 4000 capsules — — FDA listed —
DayTime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 53345-0025-01 Humanwell 4000 capsules — — FDA listed —
ASP Daytime PE 325 mg/1; 10 mg/1; 5 mg 53345-0052-01 Humanwell 4000 capsules — — FDA listed —
DayTime Cold/Flu Relief 325 mg/1; 10 mg/1; 5 mg 55301-0604-03 ARMY 12 capsules — — FDA listed —
Maximum Strenght Day Cold And Flu Formula 325 mg/1; 10 mg/1; 5 mg 55319-0933-22 FAMILY 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 55319-0967-08 Family 1 capsule — — FDA listed —
Sanatos Daytime 325 mg/1; 10 mg/1; 5 mg 55758-0508-08 Pharmadel 8 capsules — — FDA listed —
Sanatos Daytime Relief 325 mg/1; 10 mg/1; 5 mg 55758-0514-08 Pharmadel 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 55910-0982-08 Dolgencorp, 1 capsule — — FDA listed —
dg health cold plus flu relief 325 mg/1; 10 mg/1; 5 mg 55910-0994-51 Dolgencorp, 2 capsules — — Discontinued —
daytime 325 mg/1; 10 mg/1; 5 mg 56062-0417-62 Publix 2 capsules — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 57243-0604-03 SALADO 12 capsules — — FDA listed —
Daytime Cold And Flu Multi-Symptom Relief 325 mg/1; 10 mg/1; 5 mg 58602-0768-15 Aurohealth 16 capsules — — FDA listed —
Kroger DayTime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 59450-0046-48 The 12 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 59726-0850-24 P 1 capsule — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 59726-0898-08 P 1 capsule — — Discontinued —
Mucinex Sinus-Max Severe Congestion and Pain 325 mg/1; 10 mg/1; 5 mg 63824-0692-16 Reckitt 8 capsules — — FDA listed —
Cold and Flu Daytime 325 mg/1; 10 mg/1; 5 mg 63868-0736-24 QUALITY 1 capsule — — FDA listed —
Circle K Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 66715-5571-08 Lil' 2 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 66715-6815-08 Lil' 2 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 67091-0394-24 WinCo 1 capsule — — FDA listed —
Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 68016-0797-16 Chain 1 capsule — — Discontinued —
Daytime Cold And Flu Multi-Symptom Relief 325 mg/1; 10 mg/1; 5 mg 68016-0877-16 Chain 16 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 68210-5053-01 Prodose, 3000 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 69168-0417-29 Allegiant 8 capsules — — FDA listed —
DayTime Cold Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69256-0898-24 Harris 1 capsule — — FDA listed —
Vicks DayQuil ULTRA CONCENTRATED COLD and FLU 5 mg/1; 325 mg/1; 10 mg 69423-0800-48 The 48 capsules — — FDA listed —
Vicks DayQuil COLD and FLU 325 mg/1; 10 mg/1; 5 mg 69423-0994-02 The 2 capsules — — FDA listed —
Day-Time Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 69517-0160-10 HealthLife 10 capsules — — FDA listed —
Activcin 10 mg/1; 325 mg/1; 5 mg 69729-0008-10 OPMX 10 capsules — — FDA listed —
Coldtac Plus Softgels 10 mg/1; 325 mg/1; 5 mg 69729-0120-10 OPMX 10 capsules — — FDA listed —
Desresfriol-DX Softgels 10 mg/1; 325 mg/1; 5 mg 69729-0121-10 OPMX 10 capsules — — FDA listed —
tabcin ACTIVE 10 mg/1; 325 mg/1; 5 mg 69729-0152-10 OPMX 10 capsules — — FDA listed —
Agrifen 325 mg/1; 5 mg/1; 10 mg 69729-0802-10 OPMX 10 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69842-0848-16 CVS 1 capsule — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69842-0897-24 CVS 1 capsule — — FDA listed —
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) 325 mg/1; 10 mg/1; 5 mg 71679-0101-00 Health 3000 capsules — — FDA listed —
Gencare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 72090-0005-01 Pioneer 48 capsules — — FDA listed —
Gencare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 72090-0062-01 Pioneer 48 capsules — — FDA listed —
Basic Care Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 72288-0994-62 Amazon.com 2 capsules — — FDA listed —
Multi-Symptom Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 72476-0848-24 Care 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 72476-0898-24 Care 1 capsule — — FDA listed —
Mucinex Fast-Max Congestion and Headache Maximum Strength 325 mg/1; 10 mg/1; 5 mg 72854-0128-16 Reckitt 8 capsules — — FDA listed —
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength 325 mg/1; 10 mg/1; 5 mg 72854-0203-16 Reckitt 8 capsules — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 76162-0065-16 TopCo 16 capsules — — FDA listed —
Daytime Cold and Flu Max Maximum Strength Softgels 325 mg/1; 10 mg/1; 5 mg 76162-0912-24 Topco 12 capsules — — FDA listed —
Daytime Cold and Flu Relief Liquid Filled Softgels 325 mg/1; 10 mg/1; 5 mg 76281-0604-03 AptaPharma 12 capsules — — FDA listed —
meijer Daytime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 79481-0807-04 Meijer, 12 capsules — — FDA listed —
meijer Daytime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 79481-0827-04 Meijer, 12 capsules — — FDA listed —
Daytime Cold And Flu Relief 325 mg/1; 10 mg/1; 5 mg 80513-0303-50 Advanced 50 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 81522-0898-16 FSA 1 capsule — — FDA listed —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0023-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu mini Softgels 325 mg/1; 10 mg/1; 5 mg 83059-0050-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom mini softgels 325 mg/1; 10 mg/1; 5 mg 83059-0094-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0113-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0114-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Mini Softgels 325 mg/1; 10 mg/1; 5 mg 83059-0128-01 Shield 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 83324-0145-24 QUALITY 1 capsule — — FDA listed —
Nuvicare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 84324-0018-01 NUVICARE 10 capsules — — FDA listed —
Nuvicare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 84324-0023-01 NUVICARE 10 capsules — — FDA listed —
Dr. Simi Daytime Cold and Flu 10 mg/1; 325 mg/1; 5 mg 85786-0601-12 Farmacias 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 85828-0417-93 Grocery 24 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

🏛️
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.

What it looks like

Color orange
ShapeOval
ImprintASP;CC
Size17 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerBayer HealthCare LLC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedAug 2021
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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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

⏱️ Dosage and Administration 48 words ▾

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 119 words ▾

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 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.

🧪 Active Ingredient 16 words ▾

Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients FD&C yellow No.6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

🎯 Purpose 8 words ▾

Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant

📄 Do Not Use 106 words ▾

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 55 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

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

📄 When Using This Product 10 words ▾

When using this product do not exceed recommended dosage ·

📄 Stop Use and Ask a Doctor If 67 words ▾

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 11 words ▾

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

📄 Keep Out of Reach of Children 44 words ▾

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 14 words ▾

Other information Other information store at room temperature. Avoid excessive heat above 40ºC (104ºF).

📄 Questions or Comments 12 words ▾

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

📄 Package Label / Principal Display Panel 1 words ▾

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 , 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
2022 2023 2024 2026 10 3
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
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by 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 8 capsules (00280-0095-01). 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.
← 00280-0092-01 · Bayer 00280-0097-01 · 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.