Acetaminophen

Product NDC
55319-177
11-digit product format
553190177
Labeler code
55319
Product ID
55319-177_4654c5c0-d567-0231-e063-6294a90aa741
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
FAMILY DOLLAR
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8383108-0970-9f1e-e053-6294a90ad38fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-177-05Acetaminophen50 in 1 BOTTLETABLET506
55319-177-10Acetaminophen100 in 1 BOTTLETABLET1006
55319-177-24Acetaminophen24 in 1 BOTTLETABLET246
55319-177-25Acetaminophen250 in 1 BOTTLETABLET2506
55319-177-50Acetaminophen500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-177ACETAMINOPHEN TABLET [FAMILY DOLLAR]5Current NDC, 5 package rows20241218_f8383108-0970-9f1e-e053-6294a90ad38f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
application number: M013
CHILDRENS TYLENOLACETAMINOPHENKenvue Brands LLC3162733b-9382-39f1-e063-6294a90ac4202026-06-12WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9769e0c0-2f4c-3b7a-1a65-c98fbce116812026-06-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.54010ddf-25d1-2016-e063-6294a90a877d2026-06-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALGREENS40b4fe91-b1dd-147c-e063-6294a90a807d2026-06-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC3f17fa06-4932-b8ec-e063-6294a90a03812026-06-09WarningsExact identifier
application number: M013
Sleep Aid Plus Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companye3929179-dad2-4f7e-a971-dbf80f2b5e1b2026-06-08WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINPinnacle RX LLC53c11fb4-ba31-b5e5-e063-6394a90a9c1a2026-06-08WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Company9655c38a-126b-459e-b31d-0aa33d9eb5222026-06-08WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCdce938f5-eeba-4a76-9261-2b1324c39a312026-06-08WarningsExact identifier
application number: M013
Childrens MapapACETAMINOPHENBryant Ranch Prepack69c90cc8-846a-42cf-933a-108671689e8f2026-06-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINRugby Laboratories63fcd93a-b1db-44ba-8f2b-055a7deb205d2026-06-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENASCLEMED USA INC.707a9ea7-8f4e-4274-97bd-b8071a0ee06b2026-06-04WarningsExact identifier
application number: M013
Aspirin Adult low doseACETYLSALICYCLIC ACIDMedline Industries, LP6dd6501f-841c-4994-e053-2a91aa0ae2312026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECVS Pharmacy749e2be2-594a-4052-8fa5-45c9ade2d23c2026-06-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf8383108-0970-9f1e-e053-6294a90ad38f6
198440acetaminophen 500 MG Oral TabletSCDf8383108-0970-9f1e-e053-6294a90ad38f6
198440APAP 500 MG Oral TabletSYf8383108-0970-9f1e-e053-6294a90ad38f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-177-055531901770550 TABLET in 1 BOTTLE (55319-177-05) 50 tablet2023-09-01NoNoCurrent
55319-177-1055319017710100 TABLET in 1 BOTTLE (55319-177-10) 100 tablet2023-09-01NoNoCurrent
55319-177-245531901772424 TABLET in 1 BOTTLE (55319-177-24) 24 tablet2023-09-01NoNoCurrent
55319-177-2555319017725250 TABLET in 1 BOTTLE (55319-177-25) 250 tablet2023-09-01NoNoCurrent
55319-177-5055319017750500 TABLET in 1 BOTTLE (55319-177-50) 500 tablet2023-09-01NoNoCurrent