Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Reliever PM Extra strength (Acetaminophen, diphenhydramine hcl) NDC 0363-0863
Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · Walgreens
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-0863Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0863Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0863-10 | 0036308631000363086310 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0863-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 30, 2019 | |
| 0363-0863-15 | 0036308631500363086315 | 150 TABLET, COATED in 1 BOTTLE, PLASTIC (0363-0863-15)Marketed from Oct 30, 2019 | |
| 0363-0863-24 | 0036308632400363086324 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0863-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Oct 30, 2019 | |
| 0363-0863-25 | 0036308632500363086325 | 250 TABLET, COATED in 1 BOTTLE, PLASTIC (0363-0863-25)Marketed from Oct 30, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Pain Reliever 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
- WalgreensNDC labeler code 0363
- 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 0363-0863_0db02edd-8984-4cc4-959b-bb683da514cbSPL ID 0db02edd-8984-4cc4-959b-bb683da514cbSPL set ID 54cbbc5f-908b-47b2-b37f-3646354d3568RxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0311917159669
- 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
N400363086310followed by a unit qualifier and the quantityPackage 00363-0863-10. 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 0363-0863
- What is NDC 0363-0863?
- 0363-0863 is the product NDC for Pain Reliever PM Extra strength, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by Walgreens. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Reliever PM Extra strength (Acetaminophen, Diphenhydramine HCL).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride.
- Who is the labeler?
- Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pain Reliever PM Extra strength?
- 12 other product NDCs are listed under this name. See all Pain Reliever 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 Pain Reliever 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) |
|---|---|---|---|---|---|
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | TOP CARE (Topco Associates LLC) | 36800-466 | 36800-0466-1036800-0466-50 |
| Pain Reliever PM extra strengthacetaminophen diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-868 | 59726-0868-1059726-0868-2459726-0868-50 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-363 | 49035-0363-1049035-0363-2449035-0363-25 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Strategic Sourcing Services LLC | 62011-0420 | 62011-0420-01 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | BJWC (Berkley & Jensen / BJ's) | 68391-863 | 68391-0863-05 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Walgreens | 0363-0760 | 00363-0760-1000363-0760-50 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Strategic Sourcing Services LLC | 62011-0256 | 62011-0256-01 |
| PAIN RELIEVER PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Gelatin coatedOral | Best Choice (Valu Merchandisers Company) | 63941-231 | 63941-0231-50 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0556 | 00363-0556-0100363-0556-09 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | L.N.K. International, Inc. | 50844-556 | 50844-0556-10 |
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 |
|---|---|---|---|---|
| Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | The Kroger Co. | 30142-722 |
| Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | HyVee Inc | 42507-598 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | H E B | 37808-932 |
| Medi First Plus Cherry Cough Dropsmenthol | Menthol 7.6 mg/1 | LozengeOral | Unifirst First Aid Corporation | 47682-915 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Kramer Novis | 52083-057 |
| SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin | Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1 | TabletOral | KRAMER LABORATORIES | 55505-231 |
| Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients | Solution/ dropsOral | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 54859-606 |
| Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Dolgencorp Inc | 55910-753 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SolutionNasal | Reckitt Benckiser LLC | 63824-120 |
| Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride | Oxymetazoline hydrochloride .0005 g/mL | SprayNasal | Procter & Gamble Manufacturing GmbH | 64336-002 |
| Walgreens Honey Lemon Cough Dropsmenthol | Menthol 7.5 mg/1 | LozengeOral | Walgreens | 0363-9959 |
| Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl | Acetaminophen 500 mg/20mL + 3 more ingredients | SyrupOral | OPMX LLC | 69729-787 |
| Guaifenesin | Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9616 |
| Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Harris Teeter | 72036-175 |
| DG Health Cough Drops Cherry Flavormenthol | Menthol 5.8 mg/1 | LozengeTopical | Dollar General Corporation | 75712-005 |
| Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | NUVICARE LLC | 84324-019 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6985 |
| severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Rite Aid Corporation | 11822-3120 |
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