Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen and Diphenhydramine HCL NDC 41415-661
Diphenhydramine 25 mg/1; Acetaminophen 500 mg/1 · Tablet · Oral · PUBLIX SUPERMARKETS, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41415-661-05 | 41415066105 | 50 TABLET in 1 BOTTLE (41415-661-05)Marketed from Aug 2, 2024 | |
| 41415-661-10 | 41415066110 | 100 TABLET in 1 BOTTLE (41415-661-10)Marketed from Aug 2, 2024 |
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 and Diphenhydramine HCL
- Generic name (nonproprietary)
- acetaminophen and diphenhydramine hcl
- Active ingredients
- Diphenhydramine — 25 mg/1Acetaminophen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PUBLIX SUPERMARKETS, INCNDC labeler code 41415
- 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 41415-661_465302f5-b590-5105-e063-6394a90aa9d0SPL ID 465302f5-b590-5105-e063-6394a90aa9d0SPL set ID 08f549cf-042a-7bf2-e063-6394a90a83efRxCUI 1092189UNII 8GTS82S83M, 362O9ITL9D
- 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
N441415066105followed by a unit qualifier and the quantityPackage 41415-0661-05. 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 41415-661
- What is NDC 41415-661?
- 41415-661 is the product NDC for Acetaminophen and Diphenhydramine HCL, Diphenhydramine 25 mg/1; Acetaminophen 500 mg/1 tablet, listed with the FDA by PUBLIX SUPERMARKETS, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen and Diphenhydramine HCL.
- What is the active ingredient?
- Diphenhydramine, Acetaminophen.
- Who is the labeler?
- PUBLIX SUPERMARKETS, INC, NDC labeler code 41415. 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 and Diphenhydramine HCL?
- 1 other product NDC are listed under this name. See all Acetaminophen and Diphenhydramine HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen and Diphenhydramine HCL 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 and Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | SAFEWAY | 21130-661 | 21130-0661-1021130-0661-2021130-0661-24 |
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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