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		2026-10-21

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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	2024-07-02	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Exact identifier application number: M013
Back Pain Relief Extra Strength Doans	MAGNESIUM SALICYLATE	Wildman Business Group	2e17664f-a83f-48d1-8b2b-37f41eea65b6	2024-07-01	Warnings	Exact identifier application number: M013
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4fb4f4b2-c238-4933-b874-08def3b34a28	2024-06-26	Warnings	Exact identifier application number: M013
good neighbor pharmacy pain and fever childrens	ACETAMINOPHEN	Amerisource Bergen	ca0833ef-837b-47dc-8676-e016af96622c	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4a030c3e-8104-4a0a-98c5-6ab469451f20	2024-06-26	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	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