Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen Extra Strength (Acetaminophen) NDC 81522-104
Acetaminophen 500 mg/1 · Tablet, Coated · Oral · FSA Store Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)81522-104Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81522-0104Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81522-104-04 | 81522010404 | 1 BOTTLE, PLASTIC in 1 CARTON (81522-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 11, 2023 | |
| 81522-104-06 | 81522010406 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-104-06)Marketed from May 3, 2023 |
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)
- Acetaminophen Extra StrengthSuffix: Extra Strength
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 500 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- FSA Store Inc.NDC labeler code 81522
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 81522-104_24996677-f6f7-01be-e063-6394a90a10d7SPL ID 24996677-f6f7-01be-e063-6394a90a10d7SPL set ID ec6add55-f4a3-7818-e053-2a95a90aee04RxCUI 198440UNII 362O9ITL9D
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
N481522010404followed by a unit qualifier and the quantityPackage 81522-0104-04. 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: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 81522-104
- What is NDC 81522-104?
- 81522-104 is the product NDC for Acetaminophen Extra Strength (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by FSA Store Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen Extra Strength (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- FSA Store Inc., NDC labeler code 81522. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen Extra Strength?
- 25 other product NDCs are listed under this name. See all Acetaminophen Extra Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen Extra Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar Stores, LLC | 55319-062 | 55319-0062-1055319-0062-50 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-429 | 75907-0429-02 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-433 | 75907-0433-0175907-0433-52 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Bi-Mart | 37835-507 | 37835-0507-0137835-0507-0537835-0507-25 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-070 | 81522-0070-13 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | WALMART INC. | 79903-268 | 79903-0268-23 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Family Dollar Stores, LLC | 55319-053 | 55319-0053-1455319-0053-21 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Better Living Brands LLC | 21130-155 | 21130-0155-2121130-0155-35 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Aurohealth LLC | 58602-776 | 58602-0776-88 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Aurohealth LLC | 58602-746 | 58602-0746-44 |
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 Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-070 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6773 |
| MAX Cold, Flu, and Sore Throatacetaminophen,dextromethorphan hydrobromide, guaifenesin , phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | LiquidOral | H E B | 37808-316 |
| CVS Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | CapsuleOral | CVS Pharmacy | 51316-185 |
| Headache Relief, Extra Strength 24/7 Life by 7-Elevenacetaminophen, aspirin, caffeine tablet, film coated | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-5641 |
| Acetaminophen , Caffeine and pyrilamine maleate | Caffeine 60 mg/1 + 2 more ingredients | CapsuleOral | Softgel Healthcare Pvt Ltd | 35916-1234 |
| Vitapirenaacetaminophen | Acetaminophen 500 mg/1 | Granule, For solutionOral | Pharmadel LLC | 55758-012 |
| Headache Relief Extra Strengthacetaminophen, aspirin and caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Salado Sales, Inc. | 57243-334 |
| pain relieveracetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1502 |
| Acetaminophen Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALGREENS CO. | 0363-9664 |
| CVS Effervescent Antacid and Pain Relieveraspirin, anhydrous citric acid, sodium bicarbonate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | CVS Pharmacy | 69842-421 |
| Rugby Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Rugby Laboratories | 0536-1008 |
| Topcare Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Topco Associates LLC | 36800-484 |
| Regular Strength Pain Relieveracetaminophen | Acetaminophen 325 mg/1 | TabletOral | INGLES MARKETS, INC. | 62936-0102 |
| Childrens Pain Relief Dye-Freeacteaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | WinCo Foods, LLC | 67091-119 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | WALGREENS CO. | 0363-1320 |
| Chewable Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | RETAIL BUSINESS SERVICES , LLC. | 72476-205 |
| Acetaminophen PMacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | FSA STORE INC. | 81522-095 |
| Unisom PM Pain Nighttime Sleep Aid and Pain Relieveracetaminophen and diphenhydramine hydrochloride | Acetaminophen 325 mg/1; Diphenhydramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Chattem, Inc. | 41167-0040 |
| CVS Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | CapsuleOral | CVS Pharmacy | 51316-188 |
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