Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen PM Extra Strength (Acetaminophen, diphenhydramine hcl) NDC 41163-228
Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC DirectoryProduct NDC (as listed)41163-228Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41163-0228Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-228-50 | 41163022850 | 1 BOTTLE, PLASTIC in 1 BOX (41163-228-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Aug 29, 2014 |
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 Extra StrengthSuffix: Extra Strength
- Generic name (nonproprietary)
- acetaminophen, diphenhydramine hcl
- Active ingredients
- Acetaminophen — 500 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- United Natural Foods, Inc. dba UNFINDC labeler code 41163
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Marketing end
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41163-228_fe731291-4046-4366-96f7-2bcd869124f7SPL ID fe731291-4046-4366-96f7-2bcd869124f7SPL set ID 24173e77-92ec-4a87-a471-d6867837c180RxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0041163265394
- 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
N441163022850followed by a unit qualifier and the quantityPackage 41163-0228-50. 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 41163-228
- What is NDC 41163-228?
- 41163-228 is the product NDC for Acetaminophen PM Extra Strength, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen PM Extra Strength (Acetaminophen, Diphenhydramine HCl).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride.
- Who is the labeler?
- United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. 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 Extra Strength?
- 8 other product NDCs are listed under this name. See all Acetaminophen PM 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 PM 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 PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | WinCo Foods, LLC | 67091-137 | 67091-0137-50 |
| acetaminophen pm extra strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-515 | 41163-0515-0141163-0515-03 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-956 | 41163-0956-09 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | FOODHOLD U.S.A., LLC | 41520-956 | 41520-0956-0941520-0956-31 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-210 | 63868-0210-20 |
| acetaminophen pm extra strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Sam's West Inc | 68196-556 | 68196-0556-54 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | CVS PHARMACY | 69842-956 | 69842-0956-31 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-235 | 55301-0235-15 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| 12 Hour Nasal Decongestant Extra Moisturizingnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-377 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | Sheffield Pharmaceuticals LLC | 11527-140 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-378 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate solution | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | SolutionOral | Lil' Drug Store products, Inc. | 66715-6416 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| 4 Way Fast Actingphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | Haleon US Holdings LLC | 0067-2086 |
| 7 Select Maximum Strengthdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | 7-ELEVEN | 10202-740 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Health Pharma USA LLC | 71679-101 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgacetaminophen, dextromethorphan hbr and phenylephrine hcl | Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0188 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | — | KitOral | CVS Pharmacy, Inc | 51316-984 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-122 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-322 |
| Acetaminophen, Dextromethorphan HBr | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-036 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | Guaifenesin 200 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0184 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0185 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | — | KitOral | CVS Pharmacy, Inc | 51316-609 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-628 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0154 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | SOFTGEL HEALTHCARE PRIVATE LIMITED | 35916-0189 |
Showing 20 of 39.