Over-the-counter drug · OTC MONOGRAPH DRUG

Pain Relief (Acetaminophen) NDC 36800-591

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

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-591Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0591Add 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
36800-591-053680005910536800059105400 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-591-05)Marketed from Dec 23, 2019
36800-591-0836800059108368000591081 BOTTLE, PLASTIC in 1 CARTON (36800-591-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Dec 23, 2019
36800-591-1236800059112368000591121 BOTTLE, PLASTIC in 1 CARTON (36800-591-12) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Dec 23, 2019
36800-591-2036800059120368000591201 BOTTLE, PLASTIC in 1 CARTON (36800-591-20) / 225 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Dec 23, 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, 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 36800-591_2fef8293-e904-4b4a-a16a-8379d3dd1c14SPL ID 2fef8293-e904-4b4a-a16a-8379d3dd1c14SPL set ID 2e31fe65-5f50-455b-99fa-c72879f43545RxCUI 198440UNII 362O9ITL9DUPC 0036800199910

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

N436800059105 followed by a unit qualifier and the quantity

Package 36800-0591-05. 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 the common cold backache minor pain from arthritis toothache muscular aches 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 36800-591

What is NDC 36800-591?
36800-591 is the product NDC for Pain Relief (acetaminophen), Acetaminophen 500 mg/1 tablet, coated, listed with the FDA by Topco Associates, LLC. It has 4 package NDCs, 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
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralGrocery Outlet, Inc.85828-922
Pain Relief Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC83324-076
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
good neighbor pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-210
AspirinAspirin 81 mg/1Tablet, Delayed releaseOralGOODSENSE50804-880
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralMorning Star OTC53209-1002
AcetaminophenAcetaminophen 500 mg/1TabletOralCardinal Health 107, LLC55154-7897
Headache Formula Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-334
childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreen Company0363-1239
Tylenol PMacetaminophen, diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralSavings Distributors LLC73097-013
Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonateAnhydrous citric acid 1000 mg/1 + 2 more ingredientsTablet, EffervescentOralBayer HealthCare LLC.0280-4000
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1260
basic care infants pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-946
AcetaminophenAcetaminophen 500 mg/1TabletOralSportpharm LLC85766-223
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralUnited Natural Foods, Inc. dba UNFI41163-421
Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralChain Drug Consortium, LLC68016-154
Tension Headache ReliefAcetaminophen 500 mg/1; Caffeine 65 mg/1Capsule, CoatedOralAllegiant Health69168-001
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralProficient Rx LP71205-263
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-075

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