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 24 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual Relief Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	United Natural Foods, Inc. dba UNFI	807598ef-9f03-48df-b076-3ee95ef4b06c	2026-01-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength, Non-Aspirin	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1fb5e871-45fd-46fe-bf73-5192f8316e8e	2026-01-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Valu Merchandisers Company	0005aafa-08f8-4990-a54d-cc097195708f	2026-01-02	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	Walmart Inc.	152bb455-da5b-ae13-e063-6394a90acab0	2026-01-01	Warnings	Exact identifier application number: M013
Dr. Cocoa for Children Pain and Fever	ACETAMINOPHEN	Infirst Healthcare Inc.	486ea294-6d18-a907-e063-6294a90ad284	2026-01-01	Warnings	Exact identifier application number: M013
ED APAP	ACETAMINOPHEN	EDWARDS PHARMACEUTICALS, INC.	f76d5fff-ebea-40f9-aad3-4064a0c863f0	2025-12-31	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	99ec63ef-aa28-c2fb-e053-2a95a90a9f6d	2025-12-31	Warnings	Exact identifier application number: M013
Puregen Labs Acetaminophen	ACETAMINOPHEN	Advanced Rx LLC	474580af-f6b0-e440-e063-6394a90aaada	2025-12-31	Warnings	Exact identifier application number: M013
Liquid Acetaminophen	ACETAMINOPHEN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	2025-12-31	Warnings	Exact identifier application number: M013
Llorens Care Children Acetaminophen	ACETAMINOPHEN	Llorens Pharmaceutical International Division, Inc.	2a46d7d2-293b-5024-e063-6294a90a31aa	2025-12-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)	Walgreens	3a801457-c5d0-b134-e063-6294a90ac5cb	2025-12-31	Warnings	Exact identifier application number: M013
Daytime and Nighttime Severe Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Genexa Inc.	190c7eaf-dcd4-d314-e063-6294a90a6f33	2025-12-30	Warnings	Exact identifier application number: M013
BioElectro Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Genomma Lab USA	683a0fba-921c-48e7-a391-180c04f0d1c4	2025-12-30	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	0181af13-da32-4431-be39-c31fdfac9202	2025-12-29	Warnings	Exact identifier application number: M013
Gemma Cut the Cramp	ASPIRIN, CAFFEINE	Rally Labs LLC	16c9a296-077a-8e12-e063-6294a90a1b8b	2025-12-29	Warnings	Exact identifier application number: M013
Blowfish	ASPIRIN, CAFFEINE	Rally Labs LLC	0d3798bc-04ef-584e-821b-7aa76036b7d1	2025-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	ad29a37f-39a2-5c84-e053-2995a90a2f39	2025-12-29	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Pioneer Life Sciences, LLC	ac9efd62-8fee-b777-e053-2995a90a3783	2025-12-29	Warnings	Exact identifier application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry	ACETAMINOPHEN	Puro Pharma Inc.	a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009	2025-12-27	Warnings	Exact identifier application number: M013
Cystex PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Clarion Brands, LLC	9668a2ca-729e-4172-80b5-33e6c5175ba4	2025-12-27	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