FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-9798
11-digit product format
003639798
Labeler code
0363
Product ID
0363-9798_465347f3-6acd-a551-e063-6394a90a8729
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-24
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
b375de90-25c7-aa55-e053-2995a90a3cf8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0363-9798-052023-03-01Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-242023-03-01Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-052023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-242023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9798-05Acetaminophen50 in 1 BOTTLETABLET5012
0363-9798-10Acetaminophen100 in 1 BOTTLETABLET10012
0363-9798-15Acetaminophen150 in 1 BOTTLETABLET15012
0363-9798-21Acetaminophen225 in 1 BOTTLETABLET22512
0363-9798-24Acetaminophen24 in 1 BOTTLETABLET2412
0363-9798-37Acetaminophen375 in 1 BOTTLETABLET37512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9798ACETAMINOPHEN TABLET [WALGREEN CO.]11Current NDC, Legacy NDC, 6 package rows20241220_b375de90-25c7-aa55-e053-2995a90a3cf8.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 75 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-SeltzerBUFFERED ASPIRINLil' Drug Store Products, Inc.0c7a60e7-0bde-9aa2-e063-6294a90a32092023-12-14WarningsExact identifier
application number: M013
Circle K Aspirin 325ASPIRINLil Drug Store Products, Inc4cd306e3-2119-4272-9da4-a848fe2746fa2023-12-14WarningsExact identifier
application number: M013
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MARTc55b8f9d-1396-43c0-acc9-5e3485eadb072023-12-08WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MART775519ad-5683-451f-9bfc-5fafc70c68ec2023-12-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENBetter Living Brands LLCf9859be4-6d0b-2ab8-e053-6294a90aa8622023-12-06WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENKROGER COMPANYb9b7b849-c3b3-9af7-e053-2a95a90a00772023-12-06WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENKROGER COMPANYcf649478-57d2-cc88-e053-2a95a90ad1ba2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb9b6f878-1ec8-3dc0-e053-2995a90a54142023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.a48c522c-76c5-49f8-8c4d-3ee6b221e6f32023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.cc939a7c-ce56-5dd6-e053-2995a90aa8af2023-12-06WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorBUFFERED ASPIRIN, EFFERVESCENT TABLETLil' Drug Store Products, Inc.ea5df8be-a08c-5fa3-e053-2995a90a0bac2023-12-06WarningsExact identifier
application number: M013
RinglACETAMINOPHENSato Pharmaceutical Co., Ltd.ba5a0286-3e0f-4bef-96e5-29d92f51f4322023-12-06WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)41633554-474e-4d3c-9187-d90487d2ae8c2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP402c8563-b14b-453f-80bc-4275f1c737022023-12-01WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAurohealth LLC3ba51b52-7ae6-4335-b178-1b7b6ef362272023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLCbc03fa56-8880-4bbd-81a0-91853fecdd4e2023-11-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb375de90-25c7-aa55-e053-2995a90a3cf812
198440acetaminophen 500 MG Oral TabletSCDb375de90-25c7-aa55-e053-2995a90a3cf812
198440APAP 500 MG Oral TabletSYb375de90-25c7-aa55-e053-2995a90a3cf812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9798-050036397980550 TABLET in 1 BOTTLE (0363-9798-05) 50 tablet2021-09-240000-00-00NoNoCurrent
0363-9798-1000363979810100 TABLET in 1 BOTTLE (0363-9798-10) 100 tablet2021-09-240000-00-00NoNoCurrent
0363-9798-1500363979815150 TABLET in 1 BOTTLE (0363-9798-15) 150 tablet2022-09-24NoNoCurrent
0363-9798-2100363979821225 TABLET in 1 BOTTLE (0363-9798-21) 225 tablet2022-07-01NoNoCurrent
0363-9798-240036397982424 TABLET in 1 BOTTLE (0363-9798-24) 24 tablet2021-09-240000-00-00NoNoCurrent
0363-9798-3700363979837375 TABLET in 1 BOTTLE (0363-9798-37) 375 tablet2022-06-25NoNoCurrent