FDA.reportPublic FDA data

ACETAMINOPHEN 500 MG

Product NDC
76420-488
11-digit product format
764200488
Labeler code
76420
Product ID
76420-488_411a7984-fff2-6710-e063-6394a90a1704
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 500 MG
Listing expiration
2027-12-31

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
db8e6702-88ac-4db2-9dd8-7d0ed997c2b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-488-01ACETAMINOPHEN 500 MG100 in 1 BOTTLE, PLASTICTABLET1001
76420-488-10ACETAMINOPHEN 500 MG10 in 1 BOTTLE, PLASTICTABLET101
76420-488-20ACETAMINOPHEN 500 MG20 in 1 BOTTLE, PLASTICTABLET201
76420-488-30ACETAMINOPHEN 500 MG30 in 1 BOTTLE, PLASTICTABLET301
76420-488-60ACETAMINOPHEN 500 MG60 in 1 BOTTLE, PLASTICTABLET601
76420-488-90ACETAMINOPHEN 500 MG90 in 1 BOTTLE, PLASTICTABLET901

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 5 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
application number: M013
Extra Strength Pain Reliever mini softgelsACETAMINOPHEN 500 MGShield Pharmaceuticals Corp0ebb1902-6f8a-4bfb-9f2e-839d43bfca372026-08-04WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENBetter Living Brands, LLC743af02c-c762-42f5-8e01-2f62da15e04e2026-08-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC9aea8aae-8702-4c93-8b07-69cd252f44d62026-08-03WarningsExact identifier
application number: M013
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY258975d2-d8e8-407d-9804-df3b37a184e42026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINCardinal Health 107, LLC277723db-3578-4842-92eb-2de325f876492026-07-28WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNdb8e6702-88ac-4db2-9dd8-7d0ed997c2b51
198440acetaminophen 500 MG Oral TabletSCDdb8e6702-88ac-4db2-9dd8-7d0ed997c2b51
198440APAP 500 MG Oral TabletSYdb8e6702-88ac-4db2-9dd8-7d0ed997c2b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-488-0176420048801100 TABLET in 1 BOTTLE, PLASTIC (76420-488-01) 100 tablet2025-10-14NoNoCurrent
76420-488-107642004881010 TABLET in 1 BOTTLE, PLASTIC (76420-488-10) 10 tablet2025-10-14NoNoCurrent
76420-488-207642004882020 TABLET in 1 BOTTLE, PLASTIC (76420-488-20) 20 tablet2025-10-14NoNoCurrent
76420-488-307642004883030 TABLET in 1 BOTTLE, PLASTIC (76420-488-30) 30 tablet2025-10-14NoNoCurrent
76420-488-607642004886060 TABLET in 1 BOTTLE, PLASTIC (76420-488-60) 60 tablet2025-10-14NoNoCurrent
76420-488-907642004889090 TABLET in 1 BOTTLE, PLASTIC (76420-488-90) 90 tablet2025-10-14NoNoCurrent