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 36 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEXACLEAR PAIN RELIEVER	CAFFEINE, CHOLINE SALICYLATE	GM Pharmaceuticals, INC	065bd10c-3bcf-486f-a49c-40544127007f	2025-10-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	ASCLEMED USA INC.	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	2025-10-14	Warnings	Exact identifier application number: M013 ndc (product): 76420-488
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	fa33f6ef-522b-4630-9716-92371d9cd24a	2025-10-14	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Rite Aid Corporation	a8bb4f45-7a1a-4bf7-92ca-3afd508032f3	2025-10-09	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Health Pharma USA LLC	b15a7dcb-f143-4aea-8850-d0aacbf709b6	2025-10-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	3f96aeb1-a533-4d36-9a1f-62fc094b6754	2025-10-08	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	f2eb9575-d527-44c7-aa5e-efabfd9a0278	2025-10-07	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	bbc704e5-79f6-4c72-846b-cc30c5c43cb4	2025-10-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	f1ce15a3-9824-4eb5-910a-39078165f385	2025-10-07	Warnings	Exact identifier application number: M013
BupropiDex	DEXTROMETHORPHAN HYDROBROMIDE	DXM Pharmacuetical, Inc.	90cc9bcd-7891-4324-a1f4-f6df7a0457e0	2025-10-06	Warnings	Exact identifier application number: M013
Dextabs	DEXTROMETHORPHAN HYDROBROMIDE	DXM Pharmacuetical, Inc.	71b567df-844a-4563-b85a-f4592233f37d	2025-10-06	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Rising Pharma Holdings, Inc.	50f72713-50f5-4bab-9e96-b9fa73c9df1f	2025-10-06	Warnings	Exact identifier application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL	ACETAMINOPHEN 160 MG / 5 ML	MEDWISE LIFESCIENCES INC.	40507559-aee4-a603-e063-6394a90afc4f	2025-10-04	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	004c39cd-b4f4-1cae-e063-6394a90a0697	2025-10-03	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Family Dollar (FAMILY WELLNESS)	43573e35-6776-446e-aa28-75c8edc5b98d	2025-10-03	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Family Dollar (FAMILY WELLNESS)	f8e5fab4-1212-4c60-a160-9b782f76a198	2025-10-03	Warnings	Exact identifier application number: M013
CVS Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	3d71a0aa-5e03-0bdc-e063-6294a90a6634	2025-10-02	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	cc865351-34e8-4e8e-b8bf-23336c45bc61	2025-10-02	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	8e40f8f1-03c5-444b-8b5e-4532c3146e47	2025-10-02	Warnings	Exact identifier application number: M013
ASPIRIN 325 MG EC	ASPIRIN	Proficient Rx LP	9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77	2025-10-01	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