Extra Strength Acetaminophen

Product NDC: 57896-222
11-digit product format: 578960222
Labeler code: 57896
Product ID: 57896-222_27fcbced-e80c-777a-e063-6394a90a8580
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Geri-Care Pharmaceutical Corp
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-08-01
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Extra Strength Acetaminophen
Listing expiration: 2026-12-31

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
7a7b6318-b7d6-31b1-e053-2991aa0abf25	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57896-222-01	Extra Strength Acetaminophen	100 in 1 BOTTLE	TABLET	100	6
57896-222-10	Extra Strength Acetaminophen	1000 in 1 BOTTLE	TABLET	1000	6
57896-222-20	Extra Strength Acetaminophen	200 in 1 BOTTLE	TABLET	200	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-222-01	EA - Each	57896-222	365a662c-dea1-49fa-ac83-842a380b9cd4	1	2019-02-13
57896-222-10	EA - Each	57896-222	435c04a0-3126-4242-8be2-da090bc34497	1	2022-06-06
57896-222-20	EA - Each	57896-222	dbde652c-eb9a-4f10-963c-391eb28fb894	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-222	EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]	6	Current NDC, Legacy NDC, 3 package rows	20241129_7a7b6318-b7d6-31b1-e053-2991aa0abf25.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 72 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Tension Headache	ACETAMINOPHEN, CAFFEINE	Haleon US Holdings LLC	12c074d1-81ac-47d2-8747-b018cda0058a	2024-03-13	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Strive Pharmaceuticals Inc.	78c12459-3b27-4ed0-943d-520794eb438d	2024-03-07	Warnings	Exact identifier application number: M013
Pain Reliever fever Reducer Extra Strength	ACETAMINOPHEN	CVS Pharmacy	7b5263ad-01b7-4fc5-9384-4da8efe89e35	2024-03-06	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	11a8439b-0159-4351-b0f5-fe7fad6a33c0	2024-03-05	Warnings	Exact identifier application number: M013
Winco Foods Effervescent Pain Relief	ASPIRIN	Winco Foods, LLC	128afdd7-a9d1-8957-e063-6294a90af569	2024-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	Care One (Retail Business Services, LLC.)	6659e103-fa03-4de0-af42-d2fbd548a87c	2024-03-05	Warnings	Exact identifier application number: M013
Dolex Children Pain and Fever	ACETAMINOPHEN	Pharmadel LLC	f9158463-aeb1-5de0-e053-6294a90a748b	2024-03-04	Warnings	Exact identifier application number: M013
SEDALMEX FORTE	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Belmora LLC	33b3508e-4caa-4d05-9b15-cb82a2ee2d4d	2024-02-28	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AMERISOURCE BERGEN	2b923a97-836c-4dac-a8c0-3047a35fb62e	2024-02-23	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	BJWC (Berkley & Jensen / BJ's)	b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86	2024-02-22	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	31a41976-7f65-42d7-acf5-de9c2c5ca58e	2024-02-20	Warnings	Exact identifier application number: M013
Publix Fast Relief Effervescent - Original Flavor	ASPIRIN	PUBLIX SUPER MARKETS INC.	0a342f72-45fd-3e12-e063-6394a90ae33e	2024-02-16	Warnings	Exact identifier application number: M013
Equaline Effervescent Pain Reliever	ASPIRIN	UNITED NATURAL FOODS, INC. DBA UNFI	0761299a-e913-7665-e063-6394a90a6003	2024-02-16	Warnings	Exact identifier application number: M013
TopCare Effervescent Pain Relief	ASPIRIN	TOPCO ASSOCIATES LLC	075f36e1-110c-e839-e063-6294a90a89d7	2024-02-16	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	115d0b4f-6f0f-79a9-e063-6394a90ab18a	2024-02-14	Warnings	Exact identifier application number: M013
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	e1799765-c247-42b4-ad6a-8ba7d136abf2	2024-02-06	Warnings	Exact identifier application number: M013
Panadol Cold and Flu NonDrowsy	ACETAMINOPHEN AND PHENYLEPRINE HCL	Haleon US Holdings LLC	f626ab17-01c9-4493-ba9e-0c8c11146384	2024-02-06	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	7a7b6318-b7d6-31b1-e053-2991aa0abf25	6
198440	acetaminophen 500 MG Oral Tablet	SCD	7a7b6318-b7d6-31b1-e053-2991aa0abf25	6
198440	APAP 500 MG Oral Tablet	SY	7a7b6318-b7d6-31b1-e053-2991aa0abf25	6
198440	acetaminophen 500 MG Oral Tablet	PSN	b25faa8c-2d13-450a-970f-81c17a633030	1
198440	acetaminophen 500 MG Oral Tablet	SCD	b25faa8c-2d13-450a-970f-81c17a633030	1
198440	APAP 500 MG Oral Tablet	SY	b25faa8c-2d13-450a-970f-81c17a633030	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-222-01	57896022201	100 TABLET in 1 BOTTLE (57896-222-01)	100 tablet	2018-08-01	0000-00-00	No	No	Current
57896-222-10	57896022210	1000 TABLET in 1 BOTTLE (57896-222-10)	1000 tablet	2018-08-01	0000-00-00	No	No	Current
57896-222-20	57896022220	200 TABLET in 1 BOTTLE (57896-222-20)	200 tablet	2018-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
gc222	Preferred Pharmaceuticals Inc.	2026-01-28	HUMAN OTC DRUG LABEL	1
gc222	Geri-Care Pharmaceutical Corp	2024-11-28	HUMAN OTC DRUG LABEL	6
Acetaminophen	NuCare Pharmaceuticals,Inc.	2022-02-07	HUMAN OTC DRUG LABEL	2