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	2026-10-23
excluded package	package	57344-170	57344-170-03	D	Discontinued by firm	2026-10-23
excluded package	package	57344-170	57344-170-12	D	Discontinued by firm	2026-10-23

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 49 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	38b839b6-de7d-4f33-a19a-efc92cdad92c	2025-01-24	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	523b68da-cd2a-4960-95e7-de5d51ce33c1	2025-01-23	Warnings	Exact identifier application number: M013
Safety Coated Aspirin 81 mg Low Dose	ASPIRIN 81MG	Ulai Health LLC	3d225a11-a53b-4dc2-9c25-13cab007900f	2025-01-20	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 325 MG	Ulai Health LLC	55bb7e6c-e98c-48bd-b7bb-9848ff0273ca	2025-01-20	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MG	Ulai Health LLC	d4a568c9-a721-48d1-aebc-fc65444947ce	2025-01-20	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	c9d3cee1-531c-439f-ae19-07acd366aad6	2025-01-20	Warnings	Exact identifier application number: M013
Percogesic Original Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Medtech Products Inc.	529974c2-0121-4892-8e47-c2c447581091	2025-01-17	Warnings	Exact identifier application number: M013
Little Remedies Childrens Fever Pain Reliever	ACETAMINOPHEN	Medtech Products Inc.	e1e44c85-d10c-4997-8f85-064cda7906eb	2025-01-17	Warnings	Exact identifier application number: M013
Stanback	ASPIRIN AND CAFFEINE	Medtech Products Inc.	caaa1313-09e4-45aa-8836-346f6a370196	2025-01-17	Warnings	Exact identifier application number: M013
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	Precision Dose Inc.	5cc698fa-0841-4851-ae21-0aac8b40eb0a	2025-01-16	Warnings	Exact identifier application number: M013
Ecotrin	ASPIRIN	Medtech Products Inc.	222d187b-aae6-410b-baeb-b2bd42f5c676	2025-01-16	Warnings	Exact identifier application number: M013
Children Pain and Fever Reliever	ACETAMINOPHEN	Target Corporation	0dd643a4-3cbc-423d-95b4-ba373b09d895	2025-01-16	Warnings	Exact identifier application number: M013
Chewable Low Dose Aspirin	ASPIRIN	TARGET CORPORATION	f934e72a-2e9f-da17-e053-6394a90a1a2e	2025-01-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	2651bf11-4d66-43ba-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M013
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

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