ACETAMINOPHEN 500 MG

Product NDC: 50090-7961
11-digit product format: 500907961
Labeler code: 50090
Product ID: 50090-7961_50c13130-05da-459d-b94d-d930f6599768
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-11-01
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 500 MG
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	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
92559d65-f5e2-4054-9763-b9c560452dab	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7961-0	ACETAMINOPHEN 500 MG	14 in 1 BOTTLE	TABLET	14		1

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 53 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
St. Joseph Chewable Low Dose Aspirin	ASPIRIN	Foundation Consumer Healthcare LLC	248cd302-e380-4837-bdae-9df620b67e8a	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	2d98e390-4f2a-41cc-b307-3d2f6a3700dd	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	409b5fcd-5880-4dda-85d8-26aeceb4f8ab	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	c0c31523-c4c5-43c2-8d72-4d1456c720e9	2024-12-02	Warnings	Exact identifier application number: M013
NOTTS - Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	e6754f62-e3b2-773f-e053-2a95a90ad36a	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	a891896d-c9fa-4448-915a-e6b531157d22	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	SAFEWAY	d2d15e06-e9eb-3d2b-e053-2995a90a1cec	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	TopCo Associates LLC	c2d33352-431c-4683-a4fa-a54437e7b8d2	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	TopCo Associates LLC	bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Adult Low Dose	ASPIRIN	TopCare	14d010fb-c4a1-4c3d-942f-58719727bfc0	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc	c4473ee6-4e01-1ec2-e053-2995a90ac513	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Proficient Rx LP	9c186289-e309-45e8-8934-1d0eae0375c2	2024-12-01	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	22f63d62-c941-5b8f-e063-6394a90aeecd	2024-11-28	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a7b6318-b7d6-31b1-e053-2991aa0abf25	2024-11-28	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	INGLES MARKETS, INC.	27fd288e-c07a-617f-e063-6394a90a17a4	2024-11-28	Warnings	Exact identifier application number: M013
BAYER Aspirin Original, TRAVEL BASIX	ASPIRIN	Lil' Drug Store Products, Inc.	7f5d9ebe-8119-49a2-9380-eca18a5e5e85	2024-11-27	Warnings	Exact identifier application number: M013
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Jones Healthcare Group - Packaging Services, Inc	c4168e4d-3dfc-4e51-a32e-14704cb59c66	2024-11-27	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief	ACETAMINOPHEN, LIDOCAINE, MENTHOL	Kenvue Brands LLC	2611e984-0dd5-bda1-e063-6394a90a559a	2024-11-26	Warnings	Exact identifier application number: M013
First Aid Only Extra-Strength Non-Aspirin	ACETAMINOPHEN	Acme United Corporation	6891d57a-10a6-53de-e053-2a91aa0ac7c2	2024-11-26	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	MARC GLASSMAN, INC.	c8314910-71ff-5a55-e053-2995a90aafc7	2024-11-26	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	92559d65-f5e2-4054-9763-b9c560452dab	1
198440	acetaminophen 500 MG Oral Tablet	SCD	92559d65-f5e2-4054-9763-b9c560452dab	1
198440	APAP 500 MG Oral Tablet	SY	92559d65-f5e2-4054-9763-b9c560452dab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7961-0	50090796100	14 TABLET in 1 BOTTLE (50090-7961-0)	14 tablet	2026-05-11	No	No	Current