ACETAMINOPHEN 500 MG

Product NDC: 76420-488
11-digit product format: 764200488
Labeler code: 76420
Product ID: 76420-488_411a7984-fff2-6710-e063-6394a90a1704
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: ASCLEMED USA INC.
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
db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-488-01	ACETAMINOPHEN 500 MG	100 in 1 BOTTLE, PLASTIC	TABLET	100	1
76420-488-10	ACETAMINOPHEN 500 MG	10 in 1 BOTTLE, PLASTIC	TABLET	10	1
76420-488-20	ACETAMINOPHEN 500 MG	20 in 1 BOTTLE, PLASTIC	TABLET	20	1
76420-488-30	ACETAMINOPHEN 500 MG	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
76420-488-60	ACETAMINOPHEN 500 MG	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
76420-488-90	ACETAMINOPHEN 500 MG	90 in 1 BOTTLE, PLASTIC	TABLET	90	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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sanatos Multi Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI	Pharmadel LLC	0ab11691-5b29-55fc-e063-6394a90aa328	2023-11-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	1e223faa-f6d0-4235-bc4c-6cfca84a5b0a	2023-11-17	Warnings	Exact identifier application number: M013
SanaTos X	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	85b8ef3d-7318-7f3b-e053-2991aa0a0777	2023-11-14	Warnings	Exact identifier application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	8badbaad-eb35-4251-a779-00474819360d	2023-11-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	09935a74-34b0-0e7c-e063-6294a90a7c83	2023-11-07	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	f6dd6396-93e9-1096-e053-6394a90af06d	2023-11-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	eb644e9e-36dc-5f84-e053-2a95a90affa5	2023-11-02	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	Proficient Rx LP	46527b1f-7515-44ce-b5cb-9d24223b9af1	2023-11-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	12feb32b-4b8c-4b17-9e86-cb286457b088	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Proficient Rx LP	af8b30a0-7a56-4557-8404-cc8059fcd6bc	2023-11-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AMERIFOODS TRADING COMPANY	f6dd387d-c768-9443-e053-6394a90aca14	2023-10-31	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	AMERIFOODS TRADING COMPANY	f6cec280-17a5-5c5d-e053-6394a90a81aa	2023-10-31	Warnings	Exact identifier application number: M013
Regular Strength Aspirin	ASPIRIN	CARDINAL HEALTH, INC.	8aaa82c6-b46b-25c5-e053-2a95a90a3793	2023-10-30	Warnings	Exact identifier application number: M013
SafeTynadol	ACETAMINOPHEN	Sinew Pharma Inc.	b956d527-7ea7-e084-e053-2a95a90a866d	2023-10-28	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Magno-Humphries, Inc.	9d2275c8-0c3d-d2b3-e053-2995a90a368e	2023-10-27	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22bedb-9fb3-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	Magno-Humphries, Inc.	9d22d642-8aaf-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M013
ENTERIC COATED ASPIRIN	ASPIRIN	Magno-Humphries, Inc.	a7c02378-4213-4e57-aca2-2437ad02f786	2023-10-27	Warnings	Exact identifier application number: M013
Extraprin	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Magno-Humphries, Inc.	9d22cdc8-29c5-4273-e053-2a95a90ad0bf	2023-10-27	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	c321208c-f192-42c5-9454-e0df5d02d685	2023-10-26	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	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	1
198440	acetaminophen 500 MG Oral Tablet	SCD	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	1
198440	APAP 500 MG Oral Tablet	SY	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-488-01	76420048801	100 TABLET in 1 BOTTLE, PLASTIC (76420-488-01)	100 tablet	2025-10-14	No	No	Current
76420-488-10	76420048810	10 TABLET in 1 BOTTLE, PLASTIC (76420-488-10)	10 tablet	2025-10-14	No	No	Current
76420-488-20	76420048820	20 TABLET in 1 BOTTLE, PLASTIC (76420-488-20)	20 tablet	2025-10-14	No	No	Current
76420-488-30	76420048830	30 TABLET in 1 BOTTLE, PLASTIC (76420-488-30)	30 tablet	2025-10-14	No	No	Current
76420-488-60	76420048860	60 TABLET in 1 BOTTLE, PLASTIC (76420-488-60)	60 tablet	2025-10-14	No	No	Current
76420-488-90	76420048890	90 TABLET in 1 BOTTLE, PLASTIC (76420-488-90)	90 tablet	2025-10-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN 500 MG TABLET	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-10-14	HUMAN OTC DRUG LABEL	1