Pain Relief

Product NDC: 57344-170
11-digit product format: 573440170
Labeler code: 57344
Product ID: 57344-170_284f8938-9753-c321-e063-6294a90a4895
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: AAA Pharmaceutical, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-01
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	57344-170	57344-170-01	D	Discontinued by firm	2026-10-27
excluded package	package	57344-170	57344-170-03	D	Discontinued by firm	2026-10-27
excluded package	package	57344-170	57344-170-12	D	Discontinued by firm	2026-10-27

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	57344-170-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	57344-170-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	57344-170-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	57344-170-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	57344-170-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	57344-170-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	57344-170-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	57344-170-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	57344-170-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	57344-170-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	57344-170-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	57344-170-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	57344-170-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	57344-170-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	57344-170-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	57344-170-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	57344-170-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	57344-170-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	57344-170-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	57344-170-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	57344-170-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	57344-170-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	57344-170-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	57344-170-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	57344-170-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	57344-170-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	57344-170-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	57344-170-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	57344-170-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	57344-170-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	57344-170-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	57344-170-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	57344-170-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	57344-170-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	57344-170-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	57344-170-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Pain Relief
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
a891896d-c9fa-4448-915a-e6b531157d22	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57344-170-01	Pain Relief	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	7
57344-170-01	Pain Relief	1 in 1 CARTON	TABLET, COATED	1	7
57344-170-02	Pain Relief	1 in 1 CARTON	TABLET, COATED	1	7
57344-170-02	Pain Relief	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	7
57344-170-03	Pain Relief	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	7
57344-170-03	Pain Relief	1 in 1 CARTON	TABLET, COATED	1	7
57344-170-12	Pain Relief	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57344-170	PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.]	7	Current NDC, Legacy NDC, 7 package rows	20241204_a891896d-c9fa-4448-915a-e6b531157d22.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 57 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive infants pain and fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	45770ad6-9bf7-41bd-a724-e5260cd31fa1	2024-10-31	Warnings	Exact identifier application number: M013
Midol Complete	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET	Lil' Drug Store Products, Inc.	d20425a4-f074-4154-e053-2995a90ae9fd	2024-10-30	Warnings	Exact identifier application number: M013
up and up infants acetaminophen	ACETAMINOPHEN	Target Corporation	31104956-04d7-41b5-82be-219ded5c02a9	2024-10-30	Warnings	Exact identifier application number: M013
Sunmark Aspirin	ASPIRIN	Strategic Sourcing Services LLC	a7139686-b351-47dc-a395-832429aaa569	2024-10-30	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1	2024-10-30	Warnings	Exact identifier application number: M013
Acetaminophen	PAIN RELIEVER	McKesson	9d620700-5d00-475f-e053-2995a90a9a3f	2024-10-28	Warnings	Exact identifier application number: M013
Junior Acetaminophen Ages 6-11	ACETAMINOPHEN	Chain Drug Consortium	d356bc9c-66f1-45c3-a455-98c0b8890f78	2024-10-28	Warnings	Exact identifier application number: M013
leader Acetaminophen	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	36bdcac9-eed4-40f9-a6f2-4c1e773a6b50	2024-10-25	Warnings	Exact identifier application number: M013
GOODYS PM	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	Medtech Products Inc.	db5d6c2b-688e-4e88-a42d-0fa2b0d8140b	2024-10-25	Warnings	Exact identifier application number: M013
Goodys Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	16d774cc-4247-4bf8-9b5a-c338ffebda3d	2024-10-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	PUBLIX SUPER MARKETS INC	9e77ab7a-07e8-42aa-e053-2995a90a0d0e	2024-10-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Kroger Company	5bfd9841-c781-43be-b823-d334893ae6ed	2024-10-24	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	H E B	add6952e-9dd5-487c-93e6-337e9d6a4872	2024-10-24	Warnings	Exact identifier application number: M013
Dye Free Pain Reliever Childrens	ACETAMINOPHEN	Safeway, Inc.	7d55cb42-295f-473a-941d-71825b44a3c0	2024-10-24	Warnings	Exact identifier application number: M013
rapid release pain relief	ACETAMINOPHEN	Publix Super Markets Inc	d0b34133-d69d-47db-bf51-be942769c612	2024-10-24	Warnings	Exact identifier application number: M013
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	00146b91-008d-4b16-95b0-6077f98821be	2024-10-24	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	9a20273e-a4d1-4c38-9efb-e6347f8dc14e	2024-10-24	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e221905b-a795-c067-e053-2a95a90a02e7	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e221bbce-83de-0f03-e053-2995a90abca5	2024-10-23	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e231c2f6-927c-1ab0-e053-2995a90a6121	2024-10-23	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	a891896d-c9fa-4448-915a-e6b531157d22	7
198440	acetaminophen 500 MG Oral Tablet	SCD	a891896d-c9fa-4448-915a-e6b531157d22	7
198440	APAP 500 MG Oral Tablet	SY	a891896d-c9fa-4448-915a-e6b531157d22	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57344-170-01	57344017001	1 BOTTLE, PLASTIC in 1 CARTON (57344-170-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2017-09-01	0000-00-00	No	No	Current
57344-170-02	57344017002	1 BOTTLE, PLASTIC in 1 CARTON (57344-170-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2015-01-01	0000-00-00	No	No	Current
57344-170-03	57344017003	1 BOTTLE, PLASTIC in 1 CARTON (57344-170-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2017-09-01	0000-00-00	No	No	Current
57344-170-12	57344017012	400 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-170-12)	2017-10-01	0000-00-00	No	No	Current