TYLENOL EXTRA STRENGTH

Product NDC: 50090-5469
11-digit product format: 500905469
Labeler code: 50090
Product ID: 50090-5469_72fb757a-ac68-4800-bdc0-ace18841ef75
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: 2019-08-19
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
Ingredient	Strength
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
bcb7eb24-16cb-439e-879f-48d2f5e8ba83	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5469-0	2023-02-07	C162847	48780-1	f386c649-cc6a-0266-e053-dadaa90a7c1a	TYLENOL EXTRA STRENGTH
50090-5469-0	2023-01-30	C162847	48780-1	f386c649-cc6a-0266-e053-dadaa90a7c1a	TYLENOL EXTRA STRENGTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5469-0	TYLENOL EXTRA STRENGTH	1 in 1 CARTON	TABLET, FILM COATED	1		9
50090-5469-0	TYLENOL EXTRA STRENGTH	24 in 1 BOTTLE	TABLET, FILM COATED	24		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5469-0	EA - Each	50090-5469	7b30bff9-74b0-41cf-864d-4b5f3b52a012	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5469	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 2 package rows	20240518_bcb7eb24-16cb-439e-879f-48d2f5e8ba83.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 50 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regular Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	6158e954-32d8-4718-e053-2a91aa0a27f3	2024-12-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advanced Rx Pharmacy of Tennessee, LLC	f8375029-e567-c6a5-e053-6394a90a5b67	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Dollar General	4907056d-6013-46b1-ae86-469dc3001591	2024-12-31	Warnings	Exact identifier application number: M013
Pediacare Childrens Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	f9d531a2-234c-4feb-8f05-212dbee83dfe	2024-12-30	Warnings	Exact identifier application number: M013
Pediacare Childrens Acetaminophen Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	596372c7-eca3-4527-8e22-ab0751e2526b	2024-12-30	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	BAYER GENUINE ASPIRIN	Lil' Drug Store Products, Inc.	d17834d7-cb3e-6bf2-e053-2a95a90ae5c1	2024-12-30	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fd2b46-683e-4cf5-e053-2995a90a5512	2024-12-30	Warnings	Exact identifier application number: M013
Night Time Severe Cold and Cough Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Chain Drug Consortium, LLC	c8e9b57b-83e9-46c5-9791-02c4c2b94004	2024-12-29	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC.	1608b4f0-bf20-4024-b8f2-20a4df7a4b21	2024-12-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	f6a9ea44-08b8-4a33-bfbd-68cb2d852c39	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	cfc7eac3-35be-4002-b8ef-be1dfc8caf69	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	a3031139-4709-43f2-95a8-89840c595f7f	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	WALGREENS CO.	98bb28ed-d146-ca3d-e053-2a95a90a9eaf	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg	ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG	WALGREENS CO.	982faa74-d498-cd1e-e053-2995a90afa1e	2024-12-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	11bf6e1b-aed9-4f8f-9f03-ea911ae9f702	2024-12-23	Warnings	Exact identifier application number: M013
Rugby Regular Strength Acetaminophen	ACETAMINOPHEN	RUGBY LABORATORIES	295b0d00-4d4a-405f-9325-d01c5d4f3ed4	2024-12-20	Warnings	Exact identifier application number: M013
Walgreens Pain Relief Powder	ASPIRIN AND CAFFEINE	Walgreens Co.	61493d34-2432-4683-9b32-e1851a4337be	2024-12-18	Warnings	Exact identifier application number: M013
Reese Headache Powders	ASPIRIN AND CAFFEINE	Reese Pharmaceutical Co	386f7a6c-4bfc-4140-a67b-07f6b520d58f	2024-12-18	Warnings	Exact identifier application number: M013
NobleAid PAIN RELIEVER	ASPIRIN	Noble Otc LLC	aa08e488-2f69-4d7e-86ba-ccfad563edcf	2024-12-18	Warnings	Exact identifier application number: M013
Dollar General Headache Powders	ASPIRIN AND CAFFEINE	Dolgencorp, LLC	11b0271b-d65c-49c4-a081-d71044a0e04c	2024-12-18	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
198440	acetaminophen 500 MG Oral Tablet	SCD	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
198440	APAP 500 MG Oral Tablet	SY	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
209459	Tylenol 500 MG Oral Tablet	SY	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	bcb7eb24-16cb-439e-879f-48d2f5e8ba83	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5469-0	50090546900	1 BOTTLE in 1 CARTON (50090-5469-0) / 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-02-17	0000-00-00	No	No	Current