FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-9810
11-digit product format
003639810
Labeler code
0363
Product ID
0363-9810_59d03f57-1366-f80d-e063-6294a90a4519
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-21
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
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
543f93d1-df14-0bd2-e063-6294a90a4413Available on FDA.report

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 42 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
application number: M013
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
application number: M013
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc39800c27-f39f-cd60-e063-6394a90acd552025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397f2b63-733e-5b44-e063-6394a90a97182025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEBETTER LIVING BRANDS, LLCeb6026d5-d88a-f6b3-e053-2a95a90a5b202025-07-15WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESafewayf9597abc-3f01-4b94-8078-228e0b74677e2025-07-15WarningsExact identifier
application number: M013
Berkley and Jensen Pain ReliefACETAMINOPHENBJWCd3ee3341-93b8-487c-921e-2892d213efbb2025-07-15WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy9e459853-5951-4ae7-88a6-85b502e9dd412025-07-14WarningsExact identifier
application number: M013
Coated AspirinASPIRINL.N.K. International, Inc.e077fe14-62bb-462b-bfa3-8a83c06c22f12025-07-11WarningsExact identifier
application number: M013
EXTRA PAIN RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINETIME CAP LABS59482917-f80b-4bed-9218-068b35366eb32025-07-11WarningsExact identifier
application number: M013
Up and Up Childrens acetaminophenACETAMINOPHENTarget Corporation25a476a4-9969-49b3-94bf-b076bada4cea2025-07-10WarningsExact identifier
application number: M013
Tylenol Extra Strength CapletACETAMINOPHENJones Healthcare Group - Packaging Services, Incfba711c1-4e69-49b0-8994-97c455aebcb22025-07-09WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENL. Perrigo Companyaf7ae548-38ad-41d5-b1cb-761cd2e386d32025-07-08WarningsExact identifier
application number: M013
topcare pain reliefACETAMINOPHENTopco Associates LLC6aca88df-d3b5-4a60-b23b-1e66dc41ee7b2025-07-08WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9810-1000363981010100 TABLET in 1 CARTON (0363-9810-10) 100 tablet2026-08-21NoNoCurrent
0363-9810-2500363981025225 TABLET in 1 CARTON (0363-9810-25) 225 tablet2026-08-21NoNoCurrent
0363-9810-500036398105050 TABLET in 1 CARTON (0363-9810-50) 50 tablet2026-08-21NoNoCurrent
0363-9810-7500363981075375 TABLET in 1 BOTTLE (0363-9810-75) 375 tablet2026-08-21NoNoCurrent