Sinus Congestion and Pain Maximum Strength Acetaminophen, Phenylephrine HCl 325 mg; 5 mg Tablet, 24-count — NDC 0536-1289-35 (Billing 00536-1289-35)
This is a package of 24 tablets of Sinus Congestion and Pain Maximum Strength Acetaminophen, Phenylephrine HCl 325 mg; 5 mg Tablet from Rugby Laboratories, marketed since May 2020 and currently FDA-listed; retail pharmacies pay about $0.0853 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0536-1289-35 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0536 labeler · 1289 product · 35 package
- Package marketed since
- May 21, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 24 EA per package
- Barcode (UPC)
- 0305361289355
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 059707
- GCN: 25468
- GPI-14 (Medi-Span): 43991002100317
- HICL (First Databank): 000436
- AHFS class code: 12:12.04.00
- RxCUI (RxNorm): 1046378
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗This is an over-the-counter oral tablet marketed under FDA's OTC monograph rules for sinus and pain relief products. It contains acetaminophen, a pain reliever and fever reducer, combined with phenylephrine hydrochloride, a nasal decongestant. Together, these ingredients are typically used to help relieve sinus pressure, congestion, headache, and minor aches associated with colds or sinus conditions.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.085 | $2.05 / 24 tablets |
| 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. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00536-1289-35 You're viewing this Main listing | 2 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK | 2020-05-21 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sinus Congestion and Pain Maximum Strength 325 mg/1; 5 mgthis 00536-1289-35 | Rugby | 24 tablets | $0.085 | — | Availability likely | — |
| Sinus Pressure Pain Maximum Strength, Non-Drowsy 325 mg/1; 5 mg 46122-0443-62 | Amerisource | 24 tablets | $0.085 | — | Availability likely | — |
| Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 70000-0161-01 | Cardinal | 24 tablets | $0.085 | — | Availability likely | — |
| Sinus and Headache 325 mg/1; 5 mg 70000-0568-01 | Cardinal | 12 tablets | $0.085 | — | Availability likely | — |
| Sinus plus Headache 325 mg/1; 5 mg 83324-0094-24 | CHAIN | 12 tablets | $0.085 | — | Availability likely | — |
| Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-0607-02 | Haleon | 8 tablets | — | — | FDA listed | — |
| Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-7031-01 | Haleon | 2 tablets | — | — | FDA listed | — |
| Sinus and Headache 325 mg/1; 5 mg 00363-4066-08 | Walgreen | 12 tablets | — | — | FDA listed | — |
| Sinus And Headache 325 mg/1; 5 mg 11822-4669-08 | Rite | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure and Pain PE Maximum Strength 325 mg/1; 5 mg 11822-5022-08 | Rite | 24 tablets | — | — | FDA listed | — |
| Pain Relief Non Drowsy Daytime 325 mg/1; 5 mg 21130-0466-08 | Better | 12 tablets | — | — | Discontinued | — |
| Pain Relief Sinus Congestion 325 mg/1; 5 mg 21130-0474-08 | Better | 12 tablets | — | — | FDA listed | — |
| Sinus Relief MAXIMUM STRENGTH 325 mg/1; 5 mg 21130-0502-21 | Better | 24 tablets | — | — | FDA listed | — |
| Sinus Plus Headache 325 mg/1; 5 mg 30142-0466-08 | Kroger | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure plus Pain PE 325 mg/1; 5 mg 36800-0320-06 | TOPCO | 12 tablets | — | — | FDA listed | — |
| Sinus plus Headache 325 mg/1; 5 mg 36800-0322-05 | TOPCARE | 12 tablets | — | — | FDA listed | — |
| Sinus Congestion and Pain Daytime Non-Drowsy 325 mg/1; 5 mg 37808-0466-08 | H | 12 tablets | — | — | FDA listed | — |
| Sinus Congestion and Pain Daytime 325 mg/1; 5 mg 41163-0664-08 | United | 12 tablets | — | — | FDA listed | — |
| Sinus and Headache 325 mg/1; 5 mg 42507-0223-05 | HYVEE | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure and Pain PE 325 mg/1; 5 mg 42507-0320-06 | HYVEE | 12 tablets | — | — | FDA listed | — |
| Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 50580-0435-01 | Kenvue | 12 tablets | — | — | FDA listed | — |
| SUDAFED PE Pressure Plus Pain 325 mg/1; 5 mg 50580-0547-25 | Kenvue | 12 tablets | — | — | FDA listed | — |
| Tylenol Sinus Plus Headache Day 325 mg/1; 5 mg 50580-0598-01 | Kenvue | 12 tablets | — | — | Discontinued | — |
| Sinus and Headache 325 mg/1; 5 mg 50804-0123-05 | GOODSENSE | 12 tablets | — | — | FDA listed | — |
| sinus pressure and pain pe 325 mg/1; 5 mg 50804-0220-06 | GOODSENSE | 12 tablets | — | — | FDA listed | — |
| Sinus and Headache Daytime 325 mg/1; 5 mg 50844-0467-02 | L.N.K. | 12 tablets | — | — | FDA listed | — |
| Coltalin-Nd 325 mg/1; 5 mg 51467-0008-01 | FORTUNE | 24 tablets | — | — | FDA listed | — |
| Coltalin-Nd 325 mg/1; 5 mg 51467-0013-01 | FORTUNE | 24 tablets | — | — | FDA listed | — |
| Sinus Pressure plus Pain PE 325 mg/1; 5 mg 53943-0220-06 | DISCOUNT | 12 tablets | — | — | FDA listed | — |
| Sinus And Headache 325 mg/1; 5 mg 53943-0323-05 | DISCOUNT | 12 tablets | — | — | FDA listed | — |
| Sinus Headache and Pain Day, Non-drowsy 325 mg/1; 5 mg 55301-0446-08 | ARMY | 12 tablets | — | — | FDA listed | — |
| Suphedrine PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 55301-0902-08 | ARMY | 24 tablets | — | — | FDA listed | — |
| Sinus and Headache 325 mg/1; 5 mg 55319-0496-08 | Family | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure and Pain 325 mg/1; 5 mg 55319-0702-08 | Family | 24 tablets | — | — | FDA listed | — |
| Sinus and Headache Daytime 325 mg/1; 5 mg 55910-0466-08 | DOLGENCORP, | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 55910-0925-08 | DOLGENCORP, | 24 tablets | — | — | FDA listed | — |
| Sinus and Headache 325 mg/1; 5 mg 57344-0923-05 | AAA | 12 tablets | — | — | FDA listed | — |
| Sinus Pain And Congestion Daytime 325 mg/1; 5 mg 59779-0466-08 | CVS | 12 tablets | — | — | FDA listed | — |
| Sinus PE Pressure plus Pain MAXIMUM STRENGTH 325 mg/1; 5 mg 59779-0802-08 | CVS | 24 tablets | — | — | FDA listed | — |
| Sinus plus Headache 325 mg/1; 5 mg 63868-0582-24 | CHAIN | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure plus Pain PE 325 mg/1; 5 mg 63941-0220-06 | VALU | 12 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE and Pain Relief Maximum Strength 325 mg/1; 5 mg 67091-0209-24 | WinCo | 24 tablets | — | — | FDA listed | — |
| Sinus Congestion and Pain Relief Non-Drowsy 325 mg/1; 5 mg 67091-0213-24 | WinCo | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure plus Pain PE 325 mg/1; 5 mg 68998-0220-06 | MARC | 12 tablets | — | — | FDA listed | — |
| Sinus plus Headache 325 mg/1; 5 mg 68998-0323-05 | MARC | 12 tablets | — | — | FDA listed | — |
| Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy 325 mg/1; 5 mg 69168-0270-95 | Allegiant | 18 tablets | — | — | FDA listed | — |
| Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72036-0320-06 | Harris | 12 tablets | — | — | FDA listed | — |
| Sinus plus Headache 325 mg/1; 5 mg 72036-0323-05 | Harris | 12 tablets | — | — | FDA listed | — |
| Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72476-0120-06 | RETAIL | 12 tablets | — | — | FDA listed | — |
| Sinus And Headache 325 mg/1; 5 mg 72476-0123-05 | RETAIL | 12 tablets | — | — | FDA listed | — |
| Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 85766-0183-24 | Sportpharm | 12 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
-
UNII GYP6Z2JR6Q
FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
9 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Rugby Laboratories labeler code 00536
- First Aid Antiseptic POVIDONE-IODINE 100 mg/g Ointment NDC 0536-1271-80
- Rugby Antifungal Clotrimazole .01 g/g Cream NDC 0536-1272-11
- Rugby Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release NDC 0536-1279-12
- Stomach Relief Regular Strength Bismuth subsalicylate 525 mg/30mL Liquid NDC 0536-1286-36
- Stomach Relief Ultra Bismuth subsalicylate 525 mg/15mL Liquid NDC 0536-1287-36
- Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine HCI .25 g/100g; 14 g/100g; 74.9 g/100g Ointment NDC 0536-1288-06
- Acetaminophen 500 mg Tablet, Coated NDC 0536-1292-29
- Antacid aluminum hydroxide, magnesium hydroxide, simethicone 400 mg/10mL; 400 mg/10mL; 40 mg/10mL Liquid NDC 0536-1293-83
- Diclofenac sodium 10 mg/g Gel NDC 0536-1294-31
- Meclizine 12.5 mg Tablet NDC 0536-1297-01
- Rugby Famotidine 20 mg Tablet, Film Coated NDC 0536-1298-01
- Meclizine Hydrochloride 25 mg Tablet, Chewable NDC 0536-1299-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions do not use more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
⚠️ Warnings ▾
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.
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 Ask a doctor before use if you have heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📦 Storage and Handling ▾
Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
🧪 Active Ingredient ▾
Active ingredients (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid
🎯 Purpose ▾
Purpose Pain reliever/fever reducer Nasal decongestant
📄 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
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland
📄 Ask a Doctor or Pharmacist Before Use If ▾
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 nervousness, dizziness, or sleeplessness occur 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 These could be signs of a serious condition.
🤰 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📄 Questions or Comments ▾
Questions or comments? 1-800-426-9391
📄 Package Label / Principal Display Panel ▾
Principal display panel Rugby ® NDC 0536-1289-35 compare to the active ingredients in Sudafed PE ® Sinus Pressure + Pain* maximum strength sinus congestion & pain acetaminophen 325 mg pain reliever/fever reducer phenylephrine HCl 5 mg nasal decongestant relieves: sinus headache, sinus pressure and nasal congestion non-drowsy actual size 24 caplets Rugby 44-502 Rugby 44-502