FDA.reportPublic FDA data

Pain Reliever

Product NDC
0363-1178
11-digit product format
003631178
Labeler code
0363
Product ID
0363-1178_4279f6b6-cb09-01c6-e063-6294a90ad1e1
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-26
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
Pain Reliever
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
198439Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7aa624b-b00c-4fd3-9965-8e4d2b3eb4baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1178-50Pain Reliever50 in 1 BOTTLECAPSULE, LIQUID FILLED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1178PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [WALGREENS]4Current NDC, 1 package rows20250221_f7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba.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 4 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI87def9e0-0246-42cf-b8ea-2513d52e9f682026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENRite Aid Corporation3b5d4a5a-8c65-4db1-bf01-e8df6523f45a2026-08-04WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198439acetaminophen 500 MG Oral CapsulePSNf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba5
198439acetaminophen 500 MG Oral CapsuleSCDf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba5
198439APAP 500 MG Oral CapsuleSYf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0363-1178-500036311785050 CAPSULE, LIQUID FILLED in 1 BOTTLE (0363-1178-50) 2024-09-26NoNoCurrent