Extra Strength Acetaminophen

Product NDC: 57896-204
11-digit product format: 578960204
Labeler code: 57896
Product ID: 57896-204_45257b9e-6003-5356-e063-6294a90a1af0
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: 2018-07-01
Marketing end: 2027-02-28
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57896-204	57896-204-10	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57896-204	57896-204-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

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
7a29dde6-a177-6206-e053-2991aa0a01f2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57896-204-01	Extra Strength Acetaminophen	100 in 1 BOTTLE	TABLET	100	7
57896-204-05	Extra Strength Acetaminophen	50 in 1 BOTTLE	TABLET	50	7
57896-204-10	Extra Strength Acetaminophen	1000 in 1 BOTTLE	TABLET	1000	7
57896-204-20	Extra Strength Acetaminophen	200 in 1 BOTTLE	TABLET	200	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-204-01	EA - Each	57896-204	5b5981d9-4c39-4d62-9bb3-1944ee83a128	1	2018-12-13
57896-204-05	EA - Each	57896-204	0ef19d63-6981-46b8-a80e-e204eb7dc370	1	2021-06-02
57896-204-20	EA - Each	57896-204	a4fc79ba-8933-4ac1-9056-046d8a6d1c3b	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-204	EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]	6	Current NDC, Legacy NDC, 4 package rows	20241129_7a29dde6-a177-6206-e053-2991aa0a01f2.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 19 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin Regular Strength	ASPIRIN	Rite Aid Corporation	879e2258-f61b-47ad-a4b1-7d1e78823570	2026-03-05	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	ARMY AND AIR FORCE EXCHANGE SERVICE	87c580d3-6009-4be9-aea7-13539fbe6e31	2026-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable Orange	ASPIRIN	MAJOR PHARMACEUTICALS	fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	2026-03-05	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Kroger	41e149df-4140-95cc-e063-6294a90a866b	2026-03-03	Warnings	Exact identifier application number: M013
Medique Pain Off	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Sportpharm LLC	2b35acdc-ff88-46e6-a108-5240aac1d53f	2026-03-03	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Best Choice (Valu Merchandisers Company)	a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07	2026-03-03	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	HyVee Inc	6820a515-4004-407b-969b-c4069dc0c3b5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen, Diphenhydramine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	7be4d67e-1af9-f059-e053-2991aa0a382e	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	1f4ac0e6-e986-4c22-8248-0691d64e1a30	2026-02-26	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	Discount Drug Mart	f413a617-1166-4940-b6ec-fae32238a780	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	19735691-33f3-4e19-85ad-e5f270251ec5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger	44520aa1-b63f-4239-e063-6394a90a5e14	2026-02-25	Warnings	Exact identifier application number: M013
Leader Extra Strength Effervescent Antacid and Pain Reliever	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Cardinal Health	c5d7bf5f-3e59-52f2-e053-2a95a90a4a00	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	12fd643d-7c60-453f-a81f-407ed20e8725	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d96a1531-772b-4a5c-89e4-66fff1fa3d78	2026-02-25	Warnings	Exact identifier application number: M013
Gentle Care Kit	ZINC OXIDE	Kenvue Brands LLC	4b8f7a5a-2fc4-ea00-e063-6294a90ab95b	2026-02-24	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	444fa225-c204-45d1-b3b3-aa5650ee5d07	2026-02-23	Warnings	Exact identifier application number: M013
Excedrin Extra Strength and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	2c8df1c7-7864-48df-939c-d9ae22e0f52c	2026-02-23	Warnings	Exact identifier application number: M013
Equate Childrens Pain and Fever	ACETAMINOPHEN	Wal-Mart Stores Inc	40eedfe9-54e1-40a2-b4a2-55ff708b89cd	2026-02-23	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	ea417ddb-54b3-49e2-bec1-8fe450d9990c	101
198440	acetaminophen 500 MG Oral Tablet	SCD	ea417ddb-54b3-49e2-bec1-8fe450d9990c	101
198440	APAP 500 MG Oral Tablet	SY	ea417ddb-54b3-49e2-bec1-8fe450d9990c	101
198440	acetaminophen 500 MG Oral Tablet	PSN	7a29dde6-a177-6206-e053-2991aa0a01f2	7
198440	acetaminophen 500 MG Oral Tablet	SCD	7a29dde6-a177-6206-e053-2991aa0a01f2	7
198440	APAP 500 MG Oral Tablet	SY	7a29dde6-a177-6206-e053-2991aa0a01f2	7
198440	acetaminophen 500 MG Oral Tablet	PSN	e72bf35b-acc9-3562-e053-2995a90aeff3	1
198440	acetaminophen 500 MG Oral Tablet	SCD	e72bf35b-acc9-3562-e053-2995a90aeff3	1
198440	APAP 500 MG Oral Tablet	SY	e72bf35b-acc9-3562-e053-2995a90aeff3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-204-01	57896020401	100 TABLET in 1 BOTTLE (57896-204-01)	100 tablet	2018-07-01	2027-02-28	No	No	Current
57896-204-05	57896020405	50 TABLET in 1 BOTTLE (57896-204-05)	50 tablet	2018-07-01	2027-02-28	No	No	Current
57896-204-10	57896020410	1000 TABLET in 1 BOTTLE (57896-204-10)	1000 tablet	2018-07-01	0000-00-00	No	No	Current
57896-204-20	57896020420	200 TABLET in 1 BOTTLE (57896-204-20)	200 tablet	2018-07-01	2026-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
gc204	Bryant Ranch Prepack	2026-03-19	HUMAN OTC DRUG LABEL	101
gc204	Geri-Care Pharmaceutical Corp	2025-12-04	HUMAN OTC DRUG LABEL	7
ACETAMINOPHEN	Direct_Rx	2023-07-20	HUMAN OTC DRUG LABEL	3
gc204	NuCare Pharmaceuticals,Inc.	2022-08-26	HUMAN OTC DRUG LABEL	1
gc204	Bryant Ranch Prepack	2022-02-14	HUMAN OTC DRUG LABEL	3
gc204	Preferred Pharmaceuticals, Inc.	2021-05-04	HUMAN OTC DRUG LABEL	2
Acetaminophen - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-04-15	HUMAN OTC DRUG LABEL	1