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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	H E B	c713556c-cb9e-4ed2-bc2f-49b3d6256c0f	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Discount Drug Mart	4a1e9c79-5036-4c69-82f9-e48abc972b47	2026-04-02	Warnings	Exact identifier application number: M013
Wispirin	ASPIRIN	Wisdrug AG	4e70ec5e-d033-a525-e063-6394a90a5a93	2026-04-01	Warnings	Exact identifier application number: M013
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	ef2d75ee-9ed7-4b53-adbc-2ec40364da63	2026-03-31	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Hi-Tech Nutraceuticals, LLC	b119ba37-0ee3-851a-e053-2995a90a85b1	2026-03-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	RMT HEALTH LLC	4dc7229d-c895-1f80-e063-6394a90abfc3	2026-03-30	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	d1f05e56-c830-4f85-b685-2a5965d10a1c	2026-03-26	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	ad01aea6-4af3-469b-b99d-e1e66aa40e8d	2026-03-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Meijer Distribution Inc	c550b92e-de54-4599-9534-bd3022b0a86d	2026-03-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	AmerisourceBergen (Good Neighbor Pharmacy) 46122	db187226-0770-4934-90a4-c6ca50bdecef	2026-03-25	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	804d4b63-1bbe-47c0-ad49-39ddbeade6a3	2026-03-25	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	HyVee Inc	9d9c2bf6-8660-4987-8794-936d3102da8d	2026-03-24	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	BJWC (Berkley & Jensen / BJ's)	851228ea-eaf3-452b-a9ce-8cd244a0eaf3	2026-03-24	Warnings	Exact identifier application number: M013
FirstCare Childrens Pain Fever Acetaminophen	ACETAMINOPHEN 80 MG	USpharma Ltd	9fc05ba6-5667-457e-82c1-a8b4e16cadda	2026-03-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Aarkish Pharmaceuticals NJ Inc.	e5e9e1ce-666a-461f-8287-a4642902067c	2026-03-23	Warnings	Exact identifier application number: M013
Chewable Aspirin Low Dose	CHEWABLE ASPIRIN	Grocery Outlet	609c0389-8bed-4483-84fa-73ee73fdb4e4	2026-03-20	Warnings	Exact identifier application number: M013
Adult Low Dose Pain Reliever	ASPIRIN	TWIN MED LLC	a395acf4-f487-4c98-8c44-ca2aaaf72deb	2026-03-20	Warnings	Exact identifier application number: M013
Rapidol	ACETAMINOPHEN	Pharmadel LLC	3a210860-1fc1-e496-e063-6394a90a8705	2026-03-20	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