Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen PM NDC 81522-095
acetaminophen and diphenhydramine hydrochloride · Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · FSA STORE INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)81522-095Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81522-0095Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81522-095-03 | 81522009503 | 1 BOTTLE, PLASTIC in 1 CARTON (81522-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 2, 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 PM
- Generic name (nonproprietary)
- acetaminophen and diphenhydramine hydrochloride
- Active ingredients
- Acetaminophen — 500 mg/1Diphenhydramine hydrochloride — 25 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
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 81522-095_2499e0c3-bbc3-58aa-e063-6294a90a4ed5SPL ID 2499e0c3-bbc3-58aa-e063-6294a90a4ed5SPL set ID f4322f34-ac19-371e-e053-2a95a90ac864RxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0099581912055
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N481522009503followed by a unit qualifier and the quantityPackage 81522-0095-03. 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 temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 81522-095
- What is NDC 81522-095?
- 81522-095 is the product NDC for Acetaminophen PM, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by FSA STORE INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen PM (Acetaminophen and Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride.
- 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 PM?
- 10 other product NDCs are listed under this name. See all Acetaminophen PM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen PM 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 PMacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-090 | 72288-0090-78 |
| Acetaminophen PMacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-095 | 85828-0095-03 |
| Acetaminophen PMacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association, Inc. | 83324-070 | 83324-0070-20 |
| Acetaminophen PMacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-171 | 72476-0171-0172476-0171-03 |
| Acetaminophen PMacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-056 | 63981-0056-54 |
| Acetaminophen PMacetaminophen 500mg / diphenhydramine hcl 25mg | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Ulai Health LLC | 73057-352 | 73057-0352-03 |
| Acetaminophen PMacetaminophen, diphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6731 | 00904-6731-51 |
| Acetaminophen PMacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-171 | 72036-0171-02 |
| Acetaminophen PMacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-095 | 57344-0095-0157344-0095-0257344-0095-03+1 more |
| Acetaminophen PM | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-133 | 17714-0133-50 |
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 |
| 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 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-600 |
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