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 35 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodys Cool Orange Headache	ACETAMINOPHEN AND ASPIRIN AND CAFFEINE	Medtech Products Inc.	31212c97-9975-427e-bc3d-f7125f30299a	2025-10-23	Warnings	Exact identifier application number: M013
BC Arthritis	ASPIRIN AND CAFFEINE	Medtech Products Inc.	3a85be2d-6548-4de5-8109-60e1ca2bfca3	2025-10-23	Warnings	Exact identifier application number: M013
Goodys Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	d4325b17-23bc-44ac-868d-bb0886853a73	2025-10-23	Warnings	Exact identifier application number: M013
BC	ASPIRIN AND CAFFEINE	Medtech Products Inc.	226173d4-b6d5-4fe6-b24e-1cc5d1b31c88	2025-10-23	Warnings	Exact identifier application number: M013
BC MAX	ASPIRIN, ACETAMINOPHEN, CAFFEINE	Medtech Products Inc.	1e2a07ab-23e6-49b4-a676-212dc6880f14	2025-10-23	Warnings	Exact identifier application number: M013
Ecotrin Regular Strength	ASPIRIN	Medtech Products Inc.	36cb530b-25b2-4f62-a25d-aa04360815a8	2025-10-23	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	TOPCO ASSOCIATES LLC	bbc367cc-6c79-498e-8fca-1347e6ea1a8c	2025-10-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	b16ed4ef-689c-4df2-ab6c-207aa8b9925d	2025-10-22	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	TIME CAP LABS INC	05364eb4-07a1-a4d9-e063-6294a90a47e5	2025-10-21	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	CVS Pharmacy, Inc.	6deb854f-863e-24ad-e053-2991aa0afb17	2025-10-21	Warnings	Exact identifier application number: M013
BackAid	ACETAMINOPHEN, CAFFEINE	Kobayashi Healthcare International, Inc.	25db6bb5-96b6-4be1-e063-6294a90a2300	2025-10-21	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	1539dc44-15a0-153b-e063-6294a90a9d45	2025-10-21	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Method Pharmaceuticals, LLC	3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0	2025-10-21	Warnings	Exact identifier application number: M013
Walgreens Antacid Pain Relief Extra Strength	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	b60df498-07db-500b-e053-2a95a90aff6a	2025-10-17	Warnings	Exact identifier application number: M013
Equate Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walmart	6271b34b-55a0-40a8-e053-2a91aa0acb22	2025-10-17	Warnings, Adverse reactions	Exact identifier application number: M013
Xesso Neo	BENZOCAINE	PREMIUM NATURAL COSMETICS INC	163f32cd-4e51-950a-e063-6394a90a4816	2025-10-17	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	CHAIN DRUG MARKETING ASSOCIATION INC	913d8bdb-7644-464c-b9a6-55387ff12059	2025-10-17	Warnings	Exact identifier application number: M013
Alka-Seltzer Hangover Relief	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	dc235b06-999e-221d-e053-2a95a90a0ce1	2025-10-16	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	41386de5-5857-efab-e063-6294a90afd9c	2025-10-15	Warnings	Exact identifier application number: M013
Aspirin 81mg	ASPIRIN ENTERIC COATED TABLETS 81MG	VITANE PHARMACEUTICALS, INC	4138d4c0-baa5-1f20-e063-6394a90a788f	2025-10-15	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