FDA.reportPublic FDA data

Tylenol Extra Strength

Product NDC
50090-1695
11-digit product format
500901695
Labeler code
50090
Product ID
50090-1695_fcaa8a52-99a7-46b9-9644-c472532fc3ae
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-01
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
Tylenol Extra Strength
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
85294a70-3233-4ba5-bc36-ee3f2964aebfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1695-0Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED115
50090-1695-0Tylenol Extra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1695-0EA - Each50090-169506ea6b84-af2b-4b2c-96cc-57254bc0d28412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1695TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20240606_85294a70-3233-4ba5-bc36-ee3f2964aebf.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 25 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINESelect Consumer Group3caa0a47-de83-90d2-e063-6394a90a34362025-12-27WarningsExact identifier
application number: M013
Aspirin Pain reliverASPIRINPioneer Life Sciences, LLCc2759844-a49c-450f-e053-2a95a90a29722025-12-26WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPioneer Life Sciences, LLCaa2de3a5-a20d-33c6-e053-2a95a90ada3e2025-12-26WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENDiscount Drug Mart2aa0f9f3-924c-4a4a-bb5f-2a326acc24082025-12-26WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLC667f6f1b-5179-481c-a131-940c7937aada2025-12-26WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENPharbest Pharmaceuticals, Inc.04dbd98f-c74d-43b2-8bda-74f18be7cf6c2025-12-24WarningsExact identifier
application number: M013
Adult Low Dose Aspirin Enteric CoatedASPIRIN 81MGPharbest Pharmaceuticals, Inc.45e5bae9-22a7-4699-85ea-5b922af6b96d2025-12-24WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINBETTER LIVING BRANDS, LLC424a242f-c8c6-9dd7-e063-6394a90ab4d52025-12-24WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.2763a733-d617-4d95-8429-fbf81d9d77fb2025-12-24WarningsExact identifier
application number: M013
Pharbetol Regular strengthACETAMINOPHENPharbest Pharmaceuticals, Inc.e0a39957-d918-4125-88f9-0e550b976fa12025-12-24WarningsExact identifier
application number: M013
PHARBETOLACETAMINOPHEN 500MGPharbest Pharmaceuticals, Inc.27337be9-e279-460e-903e-ae44630995992025-12-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f5af1d-365b-a97c-e063-6394a90a99ae2025-12-23WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC0d67bb52-7ae3-439e-9e47-4e21eb0ca3522025-12-23WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC11e6ec2a-5171-4496-a15f-6ff744bd1f2f2025-12-23WarningsExact identifier
application number: M013
Aspirin Pain reliverASPIRINPioneer Life Sciences, LLC8dc29957-2ac1-47f8-89fd-a6bcf97ee3d32025-12-23WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGranules USA, Inca1255f60-b9c6-9a95-e053-2995a90a9e802025-12-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGranules USA, Inca51395ea-e038-dc9c-e053-2a95a90a287d2025-12-22WarningsExact identifier
application number: M013
CareALL AcetaminophenACETAMINOPHENNew World Imports, Inc1148b4d9-fa6a-49e6-9663-17b2c83738462025-12-22WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Incf4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac2025-12-22WarningsExact identifier
application number: M013
VitapirenaACETAMINOPHENPharmadel LLC0547bc1f-d000-f5a6-e063-6294a90ac73d2025-12-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459Tylenol Extra Strength 500 MG Oral TabletPSN85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD85294a70-3233-4ba5-bc36-ee3f2964aebf15
198440acetaminophen 500 MG Oral TabletSCD85294a70-3233-4ba5-bc36-ee3f2964aebf15
198440APAP 500 MG Oral TabletSY85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459APAP 500 MG Oral Tablet [Tylenol]SY85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459Tylenol 500 MG Oral TabletSY85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459Tylenol Extra Strength 500 MG Oral TabletSY85294a70-3233-4ba5-bc36-ee3f2964aebf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1695-0500901695001 BOTTLE, PLASTIC in 1 CARTON (50090-1695-0) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2015-02-12NoNoCurrent