acetaminophen

Product NDC: 68196-919
11-digit product format: 681960919
Labeler code: 68196
Product ID: 68196-919_2d2a7fc6-966a-4716-a3af-98e09b1dc3a7
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Sam's West Inc
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-05-10
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
Brand name suffix: extra strength
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
dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68196-919-05	acetaminophenextra strength	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68196-919	ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAM'S WEST INC]	12	Current NDC, Legacy NDC, 1 package rows	20241027_dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d.zip

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 16 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain Relief Dye free	ACTEMINOPHEN	BETTER LIVING BRANDS LLC.	41f504d1-29c4-f075-e063-6394a90ad64c	2026-04-11	Warnings	Exact identifier application number: M013
Dr. Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4f1e1f1a-44f4-2356-e063-6294a90a8cdd	2026-04-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Akron Pharma Inc.	e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed	2026-04-10	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	28413cb3-22c4-40e2-ad6b-42beb438dea3	2026-04-10	Warnings	Exact identifier application number: M013
Pain Reliever Childrens	ACETAMINOPHEN	H E B	7e43de11-d20b-4920-a04d-3c1b5d35e005	2026-04-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Navajo Manufacturing Company Inc.	f7e572e9-82a7-2127-e053-6394a90ab01a	2026-04-08	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Navajo Manufacturing Company Inc.	f6f2ce71-5728-aefb-e053-6394a90a20e4	2026-04-08	Warnings	Exact identifier application number: M013
Midol	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Navajo Manufacturing Company Inc.	cabd10f2-a91e-4406-9249-915e306c867b	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	HyVee Inc	3730ee46-b241-44eb-94fa-52b9d12a9c35	2026-04-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Walgreen Company	82cc404b-fcf5-4e48-ab1a-09d8c47f9e04	2026-04-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Cardinal Health 107, LLC	9efcce86-dd57-4ea2-ad31-d2038eb61bf1	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	1b164780-ec84-4187-8afa-6f8a0da550fc	2026-04-07	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	201b860d-dc3c-4380-affa-e757bf2103cf	2026-04-07	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreens	6e7475e2-81a9-43b5-9b81-b58ab761a6f4	2026-04-07	Warnings	Exact identifier application number: M013
Pain Relief Aspirin Low Dose	ASPIRIN	Rite Aid Corporation	503408ed-e799-48a0-8d38-3034f4a0ead5	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Lidl US LLC	468f4a2f-60f7-4808-95d7-a00be1bb112f	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Grocery Outlet, Inc.	44de6f5a-0b5c-6c28-e063-6394a90a7e0b	2026-04-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	26ae0d0a-34c0-4d16-951a-8d5a463c808b	2026-04-02	Warnings	Exact identifier application number: M013
Pain Reliever plus Sleep Aid NightTime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger Company	286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	COSTCO WHOLESALE CORPORATION	c8a8986b-1ab4-9da0-71da-42595db08b44	2026-04-02	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	dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	13
198440	acetaminophen 500 MG Oral Tablet	SCD	dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	13
198440	APAP 500 MG Oral Tablet	SY	dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68196-919-05	68196091905	400 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-919-05)	2004-05-10	0000-00-00	No	No	Current