Over-the-counter drug · OTC MONOGRAPH DRUG
Extra Strength Headache Relief (Acetaminophen, aspirin, and caffeine) NDC 80513-362
Acetaminophen 250 mg/1 + 2 more ingredients · Tablet · Oral · Advanced Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-362-15 | 8051303621580513036215 | 150 TABLET in 1 BOTTLE (80513-362-15)Marketed from Jul 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Extra Strength Headache Relief
- Generic name (nonproprietary)
- acetaminophen, aspirin, and caffeine
- Active ingredients
- Acetaminophen — 250 mg/1Aspirin — 250 mg/1Caffeine — 65 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 80513-362_3f0f7803-0747-baa9-e063-6394a90aac25SPL ID 3f0f7803-0747-baa9-e063-6394a90aac25SPL set ID a7ed4c76-a5b5-44f7-866f-f43790e45c78RxCUI 308297UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338EUPC 0380513001771
- Pharmacologic class
- Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480513036215followed by a unit qualifier and the quantityPackage 80513-0362-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps
Excerpt only. Read the full label for complete information.
About NDC 80513-362
- What is NDC 80513-362?
- 80513-362 is the product NDC for Extra Strength Headache Relief, Acetaminophen 250 mg/1 + 2 more ingredients tablet, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Extra Strength Headache Relief (Acetaminophen, Aspirin, and Caffeine).
- What is the active ingredient?
- Acetaminophen, Aspirin, Caffeine.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Extra Strength Headache Relief?
- 5 other product NDCs are listed under this name. See all Extra Strength Headache Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Extra Strength Headache Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Extra Strength Headache Reliefacetaminophen aspirin caffeine | Aspirin 250 mg/1 + 2 more ingredients | Tablet, CoatedOral | WAL-MART STORES INC | 79903-044 | 79903-0044-2079903-0044-42 |
| Extra Strength Headache Reliefacetaminophen, aspirin, and caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | Lil' Drug Store Products, Inc. | 29485-6486 | 29485-6486-02 |
| Extra Strength Headache Reliefacetaminophen, aspirin, and caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, CoatedOral | Dollar General | 55910-440 | 55910-0440-01 |
| Extra Strength Headache Reliefacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | WALGREENS | 0363-8992 | 00363-8992-10 |
| Extra Strength Headache Reliefacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | WALGREENS | 0363-7214 | 00363-7214-25 |
Other NDCs under M 013
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-019 |
| Extra Strength Pain Releifacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1242 |
| Aspirin 81 mgaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | H E B | 37808-600 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1001 |
| Extra Strength Pain Relieveracetaminophen tablets 500 mg | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-0669 |
| Pain Relieveracetaminophen capsules 500mg (minis-red opaque) | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-6684 |
| Mommys Bliss Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-793 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | CVS Pharmacy | 59779-126 |
| Good Neighbor Pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-211 |
| Acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | A-S Medication Solutions | 50090-6059 |
| Members Mark Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sam's West Inc | 68196-606 |
| Mommys Bliss Infants Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-893 |
| Thompson Extra Strength Non-Aspirinacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Thompson | 73408-174 |
| Aspirin 81 mg Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-089 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-222 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | P & L Development, LLC | 49580-0282 |
| Dye Free Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreens | 0363-0285 |
| Pain Reliever Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0519 |
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