Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Reliever PM Extra Strength (Acetaminophen, diphenhydramine hcl) NDC 49035-363

Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-363Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0363Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49035-363-104903503631049035036310100 TABLET, COATED in 1 BOTTLE, PLASTIC (49035-363-10)Marketed from Jan 31, 2020
49035-363-2449035036324490350363241 BOTTLE, PLASTIC in 1 BOX (49035-363-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 31, 2020
49035-363-254903503632549035036325225 TABLET, COATED in 1 BOTTLE, PLASTIC (49035-363-25)Marketed from Jan 31, 2020

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)
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
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 49035-363_deb6f37e-6918-4276-81c2-638b9dd51cfeSPL ID deb6f37e-6918-4276-81c2-638b9dd51cfeSPL set ID 79886972-47a4-44c5-a131-1a691a328103RxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0681131357302
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

N449035036310 followed by a unit qualifier and the quantity

Package 49035-0363-10. 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.

Full label on DailyMed (opens in a new tab)

About NDC 49035-363

What is NDC 49035-363?
49035-363 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 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). It has 3 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?
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC), NDC labeler code 49035. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pain Reliever PM Extra Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralTOP CARE (Topco Associates LLC)36800-46636800-0466-1036800-0466-50
Pain Reliever PM extra strengthacetaminophen diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralP & L Development, LLC59726-86859726-0868-1059726-0868-2459726-0868-50
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralStrategic Sourcing Services LLC62011-042062011-0420-01
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralBJWC (Berkley & Jensen / BJ's)68391-86368391-0863-05
Pain Reliever PM Extra strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralWalgreens0363-086300363-0863-1000363-0863-1500363-0863-24+1 more
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralWalgreens0363-076000363-0760-1000363-0760-50
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralStrategic Sourcing Services LLC62011-025662011-0256-01
PAIN RELIEVER PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Capsule, Gelatin coatedOralBest Choice (Valu Merchandisers Company)63941-23163941-0231-50
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralWalgreen Company0363-055600363-0556-0100363-0556-09
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralL.N.K. International, Inc.50844-55650844-0556-10

All 13 Pain Reliever PM Extra Strength NDCs

Other NDCs under M 013

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 013
ProductStrengthForm · routeLabelerProduct NDC
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralATLANTIC BIOLOGICALS CORP.17856-3086
Childrens TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-614
Acetaminophen Regular strengthacetaminophenAcetaminophen 325 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-563
Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralTOP CARE (Topco Associates LLC)36800-466
Acetaminophen 325 MgacetaminophenAcetaminophen 325 mg/1TabletOralProficient Rx LP71205-456
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHarris Teeter72036-170
Topcare AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralTopco Associates LLC36800-467
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-592
Pain Relief Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-392
AcetaminophenAcetaminophen 500 mg/1TabletOralTrifecta Pharmaceuticals USA LLC69396-140
Goodnow Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralGobrands, Inc82501-0484
Tension Headache Pain Relieving Aidacetaminophen,caffeineAcetaminophen 500 mg/1; Caffeine 65 mg/1TabletOralWAL-MART STORES INC79903-373
Acetaminophen , Aspirin and CaffeineAspirin 250 mg/1 + 2 more ingredientsCapsuleOralSoftgel Healthcare Pvt Ltd35916-0709
AcetaminophenAcetaminophen 160 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0941
CareOne Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerican Sales Company41520-615
Childrens TYLENOLacetaminophenAcetaminophen 160 mg/5mLSuspensionOralKenvue Brands LLC50580-612
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthacetaminophenAcetaminophen 500 mg/1TabletOralAurex Laboratories Limited Liability Company71009-109
Acetaminophen PMacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHarris Teeter72036-171
Basic Care Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-130
good neighbor pharmacy aspirinaspirinAspirin 81 mg/1Tablet, ChewableOralAmerisource Bergen24385-278

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