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 79 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Dr. Wayne's	eacbdf9e-5642-4986-a03c-b0812d28265d	2021-11-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	d9abe780-7e58-43d8-848f-c6c8893aea2e	2021-10-14	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500MG	Allegiant Health	0f72be92-fac0-4be4-87a3-3f20f0f01db5	2021-05-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	8cacf02c-9925-40d4-92bc-78788aa0681a	2020-11-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500 MG	Allegiant Health	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	2020-03-13	Warnings	Exact identifier application number: M013
Acetaminophen 500mg ES	ACETAMINOPHEN 500MG	Allegiant Health	91acc132-01b6-467b-9af5-70f4dc93e087	2019-01-08	Warnings	Exact identifier application number: M013
Acetaminophen 325mg RS	ACETAMINOPHEN 325MG	Allegiant Health	61c6d281-e59b-4277-bbce-f71c12c2a56d	2019-01-07	Warnings	Exact identifier application number: M013
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Allegiant Health	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	2019-01-02	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	423a8445-964c-4cdb-889a-f391ca5253e7	2018-12-31	Warnings	Exact identifier application number: M013
Cold Multi-Symptom Night-time	ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI	Allegiant Health	3f020cf2-6011-4216-9b39-0b3dc5f0749c	2018-12-26	Warnings	Exact identifier application number: M013
Aspirin Chewable	ASPIRIN 81 MG	Allegiant Health	92b8637b-03a9-461f-b2f6-6eddaa214953	2018-12-21	Warnings	Exact identifier application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Allegiant Health	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	2018-12-21	Warnings	Exact identifier application number: M013
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Exact identifier application number: M013
ASPIRIN Enteric Coated	ASPIRIN 81 MG	Allegiant Health	5910a882-eb40-440f-8a30-c21fbce9050e	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN 325 MG	Allegiant Health	88b54062-8b3d-4024-a957-62b3255184b9	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5	2018-11-07	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier application number: M013
SED-MAX	ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG	Command Brands, LLC	4920a0e9-6f88-4df0-8657-77c95a3b9617	2017-01-19	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