Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Relief PM Extra Strength (Acetaminophen, diphenhydramine hcl) NDC 63868-119

Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet, Coated · Oral · QUALITY CHOICE (Chain Drug Marketing Association)

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0119Add 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
63868-119-5063868011950638680119501 BOTTLE, PLASTIC in 1 BOX (63868-119-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 31, 2015

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 Relief 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 012
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63868-119_68f2d380-71de-422f-808a-77316fcf3017SPL ID 68f2d380-71de-422f-808a-77316fcf3017SPL set ID 47660794-22cc-4863-a183-e694d27e3543RxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0635515951051
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

N463868011950 followed by a unit qualifier and the quantity

Package 63868-0119-50. 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.

Full label on DailyMed (opens in a new tab)

About NDC 63868-119

What is NDC 63868-119?
63868-119 is the product NDC for Pain Relief PM Extra Strength, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, coated, listed with the FDA by QUALITY CHOICE (Chain Drug Marketing Association). It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Relief PM Extra Strength (Acetaminophen, Diphenhydramine HCl).
What is the active ingredient?
Acetaminophen, Diphenhydramine hydrochloride.
Who is the labeler?
QUALITY CHOICE (Chain Drug Marketing Association), NDC labeler code 63868. 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 Relief PM Extra Strength?
12 other product NDCs are listed under this name. See all Pain Relief 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 Relief PM Extra Strength NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-08583324-0085-0183324-0085-50
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-19568998-0195-02
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralMARC GLASSMAN, INC.68998-07168998-0071-03
Pain Relief PM Extra Strengthpain relief pmAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralAllegiant Health69168-00369168-0003-50
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralGoodSense50804-82550804-0825-02
Pain Relief PM Extra Strengthacetaminophen 500 mg and diphenhydramine hcl 25 mgAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1TabletOralAllegiant Health69168-39369168-0393-0269168-0393-2469168-0393-26+2 more
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHEB37808-79537808-0795-03
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralTopCo Associates LLC36800-09536800-0095-0336800-0095-17
Pain Relief PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralH E B37808-55637808-0556-0937808-0556-31
Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralDOLGENCORP, LLC55910-65555910-0655-1055910-0655-31

All 13 Pain Relief PM Extra Strength NDCs

Other NDCs under M 012

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

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Cough Reliefdextromethorphan hydrobromideDextromethorphan hydrobromide 15 mg/1Capsule, Liquid filledOralAdvanced Rx LLC80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr—KitTARGET CORPORATION82442-559
Geri-Dryl allergy reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVerityRx83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitTARGET Corporation11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxidePetrolatum 49 g/100g; Zinc oxide 15 g/100gCreamTopicalWelmedix LLC24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralTopco Associates LLC36800-143
Allergy Childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralH E B37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralH E B37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesinDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralStrategic Sourcing Services LLC49348-728
Dual Action Honey Lemon Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola Ag54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hclAcetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mLLiquidOralHaleon US Holdings LLC0031-0101
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola USA Inc.63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coatedGuaifenesin 200 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store products, Inc.66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsCapsule, Liquid filledOralWalgreens0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hclAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralWalgreens0363-9130
Pyrilamine Maleate and Dextromethorphan HydrobromideDextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mLLiquidOralWestminster Pharmaceuticals, LLC69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAptaPharma Inc.76281-604
Cough DropsmentholMenthol 5.8 mg/1PastilleOralTopco Associates LLC76162-016

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