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 52 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e5df0e-06d3-6f72-e053-2995a90a2d07	2024-12-14	Warnings	Exact identifier application number: M013
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	2928e140-c868-5bf5-e063-6394a90ab024	2024-12-13	Warnings	Exact identifier application number: M013
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	b8ee568c-80cf-4e35-865e-35516bdab0fd	2024-12-13	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	c0de0bd2-4868-46dc-a20f-3ca02caaa26b	2024-12-11	Warnings	Exact identifier application number: M013
Rite Aid Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Rite Aid	b4797380-9cef-d640-e053-2a95a90a0665	2024-12-11	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE	Tower Laboratories Ltd	44babed8-cf38-1c12-e054-00144ff8d46c	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	b5e2300a-b77b-53cc-e053-2a95a90a7a6e	2024-12-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH Headache Relief geltabs	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	b432771a-4f7d-4d39-a038-d1561d8f6708	2024-12-11	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6	2024-12-10	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	UNFI	e689c9e3-dd4d-c646-e053-2a95a90a4b6a	2024-12-09	Warnings	Exact identifier application number: M013
DrKids Childrens Pain and Fever	ACETAMINOPHEN 80MG/PIECE	CalmCo LLC	ff4b0528-39a0-80d5-e053-6394a90a8a83	2024-12-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	972f09a7-2aa1-4b1b-a6dc-2c4578a07803	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6feff0a-3347-194d-e053-2a95a90acd20	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6fee238-0b6f-cb84-e053-2995a90a361b	2024-12-05	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	L.N.K. International, Inc.	379ef03c-3b6a-40c3-b736-99f0537d26c8	2024-12-05	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Marc Glassman, Inc.	43bf297f-2832-424f-a013-4bfa1d6c03e6	2024-12-04	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	5a68ab98-720c-479a-a60a-4e594add6c09	2024-12-04	Warnings	Exact identifier application number: M013
HEB Effervescent Pain Relief	ASPIRIN	H. E. BUTT GROCERY COMPANY	03876c71-60ec-3280-e063-6294a90a62dc	2024-12-03	Warnings	Exact identifier application number: M013
Migrafein FORTE	ACETAMINOPHEN, CAFFEINE	OPMX LLC	028875c9-4129-ce2c-e063-6294a90a26cc	2024-12-03	Warnings	Exact identifier application number: M013
Neo-Lubrina Fuerte	ACETAMINOPHEN, CAFFEINE	OPMX LLC	0288a327-fd4b-1991-e063-6294a90ace50	2024-12-03	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