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 50 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASPIRIN 325 MG EC	ASPIRIN	Reliable 1 Laboratories LLC	2ab8564f-f958-7512-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 325 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	25626b46-78f8-7226-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Reliable 1 Laboratories LLC	b247fe39-7f65-e502-e053-2a95a90a08f1	2025-01-15	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	e64ce7b1-4501-4b51-b012-1882ed153b42	2025-01-13	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN 325MG	Ulai Health LLC	26942d32-d6e6-464d-8fc4-ffd9806d3e62	2025-01-12	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	a354b24e-0913-829f-e053-2995a90ad407	2025-01-11	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	8f221fdb-8138-c1a8-e053-2995a90a29c2	2025-01-11	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	3294ba24-f198-485e-88fc-435964434b80	2025-01-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	32ea1230-f9ae-46b0-910e-05cd187cee34	2025-01-09	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	e817bc4a-43ef-4126-b903-aabd1390cd0c	2025-01-08	Warnings	Exact identifier application number: M013
GeriCare Liquid Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceuticals, Corp	85a074da-14b7-4db5-9d47-8ad19f520721	2025-01-06	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	Meijer Distribution Inc	eb29d6be-f095-44b2-b6ed-7e4167b596f8	2025-01-02	Warnings	Exact identifier application number: M013
Headache, Circle K	ACETAMINOPHEN, CAFFEINE, ASPIRIN TABLET	Lil' Drug Store Products, Inc.	e711ff0a-2fa0-1f2a-e053-2a95a90a4e38	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache, Lil Drug Store	EXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0c41deda-490b-f5d2-e063-6394a90a5047	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache, Circle K	ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET	Lil' Drug Store Products, Inc.	d18e1631-de43-4b29-e053-2995a90af56d	2024-12-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED TABLET	Lil' Drug Store Products, Inc.	e5f9def4-4cf5-4e06-e053-2995a90a07ea	2024-12-31	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	6158e954-32d8-4718-e053-2a91aa0a27f3	2024-12-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advanced Rx Pharmacy of Tennessee, LLC	f8375029-e567-c6a5-e053-6394a90a5b67	2024-12-31	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Dollar General	4907056d-6013-46b1-ae86-469dc3001591	2024-12-31	Warnings	Exact identifier application number: M013
Pediacare Childrens Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	f9d531a2-234c-4feb-8f05-212dbee83dfe	2024-12-30	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