Acetaminophen tablets USP 500 mg (Round)

Manufacturer: Granules India Limited
Effective date: 2023-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:54:02

Label at a glance#

ProductAcetaminophen 500 mg Round

Active ingredientACETAMINOPHEN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

apap-500-mg-red

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	3
198440	acetaminophen 500 MG Oral Tablet	SCD	3
198440	APAP 500 MG Oral Tablet	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62207-538-85	Acetaminophen 500 mgRound	90000 in 1 BOX	TABLET	90000		3
62207-538-87	Acetaminophen 500 mgRound	15000 in 1 BOX	TABLET	15000		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-538	ACETAMINOPHEN 500 MG ROUND (ACETAMINOPHEN) TABLET [GRANULES INDIA LIMITED]	3	2 package rows	20230213_ebe97ec1-bb02-9dc4-e053-2995a90a149d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Acetaminophen 500 mg Round
Acetaminophen
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
LECITHIN, SOYBEAN
FD&C RED NO. 40
POVIDONE K30
FD&C YELLOW NO. 6
STARCH, CORN
SUCRALOSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62207-538	62207-538-87, 62207-538-85

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
POVIDONE K30	U725QWY32X	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f339915b-70e9-3ab6-e053-2a95a90a1b91			ebe97ec1-bb02-9dc4-e053-2995a90a149d	2023-01-27		Exact identifier spl id: f339915b-70e9-3ab6-e053-2a95a90a1b91 spl set id: ebe97ec1-bb02-9dc4-e053-2995a90a149d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.