Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Relief (Acetaminophen) NDC 36800-991

Acetaminophen 500 mg/1 · Tablet, Film coated · Oral · Topco Associates, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-991Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0991Add 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
36800-991-1536800099115368000991151 BOTTLE, PLASTIC in 1 CARTON (36800-991-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jan 30, 2019

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
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Topco Associates, LLCNDC labeler code 36800
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 013
Marketing start
Listing expires
Identifiers
Product ID 36800-991_44608f7f-377f-4006-9c9e-d154e3a45e10SPL ID 44608f7f-377f-4006-9c9e-d154e3a45e10SPL set ID 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101RxCUI 198440UNII 362O9ITL9DUPC 0036800115842

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

N436800099115 followed by a unit qualifier and the quantity

Package 36800-0991-15. 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 temporarily relieves minor aches and pains due to: headache toothache muscular aches backache the common cold minor pain from arthritis premenstrual and menstrual cramps temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-991

What is NDC 36800-991?
36800-991 is the product NDC for Pain Relief (acetaminophen), Acetaminophen 500 mg/1 tablet, film coated, listed with the FDA by Topco Associates, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pain Relief (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Topco Associates, LLC, NDC labeler code 36800. 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?
62 other product NDCs are listed under this name. See all Pain Relief 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pain ReliefacetaminophenAcetaminophen 325 mg/1TabletOralShield Pharmaceuticals Corp.83059-0160—
Pain Reliefmenthol sprayMenthol 76.6 mg/mLSprayTopicalOwell Naturals Brand, LLC83570-00383570-0003-02
Pain Reliefarnica montana, belladonna, gelsemium sempervirens, gnaphalium polycephalum, magnesia phosphorica, sanguinaria canadensis, salix albaArnica montana whole 6 [hp_X]/1 + 6 more ingredientsTabletOralNaturalCare70163-002270163-0022-01
pain reliefacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralHyVee Inc42507-81342507-0813-78
Pain ReliefmentholMenthol 10.5 g/100mLSprayTopicalTrifecta Pharmaceuticals USA, LLC.69396-17569396-0175-03
Pain ReliefacetaminophenAcetaminophen 500 mg/1TabletOralHYVEE INC42507-10342507-0103-04
Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHYVEE INC42507-30342507-0303-03
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-40442507-0404-09
Pain ReliefacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralHYVEE INC42507-59242507-0592-03
Pain RelieflidocaineLidocaine .04 g/gPatchTopicalShanghai Chuangshi Medical Technology (Group) Co., Ltd.73557-18973557-0189-30

All 63 Pain Relief 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
AcetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralCOSTCO WHOLESALE CORPORATION63981-019
Extra Strength Pain ReleifacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralStrategic Sourcing Services, LLC70677-1242
Aspirin 81 mgaspirinAspirin 81 mg/1Tablet, Delayed releaseOralH E B37808-600
TYLENOL Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, Film coatedOralMorning Star OTC53209-1001
Extra Strength Pain Relieveracetaminophen tablets 500 mgAcetaminophen 500 mg/1TabletOralWALGREENS0363-0669
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)Acetaminophen 500 mg/1Capsule, Liquid filledOralWalgreens0363-6684
Mommys Bliss Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralMom Enterprises, LLC.71444-793
Childrens Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralCVS Pharmacy59779-126
Good Neighbor Pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-211
AcetaminophenAcetaminophen 160 mg/5mLLiquidOralA-S Medication Solutions50090-6059
Members Mark AcetaminophenacetaminophenAcetaminophen 500 mg/1TabletOralSam's West Inc68196-606
Mommys Bliss Infants Pain and FeveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralMom Enterprises, LLC.71444-893
Thompson Extra Strength Non-AspirinacetaminophenAcetaminophen 500 mg/1TabletOralThompson73408-174
Aspirin 81 mg Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-089
AcetaminophenAcetaminophen 500 mg/1TabletOralASCLEMED USA INC.87063-222
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
Pain and Fever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralP & L Development, LLC49580-0282
Dye Free Pain and Fever ChildrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreens0363-0285
Pain Reliever Extra StrengthacetaminophenAcetaminophen 500 mg/1Tablet, CoatedOralWalgreen Company0363-0519

Showing 20 of 40.

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