Pain Relief

Product NDC: 69168-328
11-digit product format: 691680328
Labeler code: 69168
Product ID: 69168-328_7ed5b51e-f50e-42cd-965e-2962d68ec75f
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen 500 mg
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-17
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69168-328	69168-328-03	D	Discontinued by firm		2026-10-16

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69168-328-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69168-328-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69168-328-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69168-328-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69168-328-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69168-328-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69168-328-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69168-328-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69168-328-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69168-328-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69168-328-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69168-328-03	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69168-328-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69168-328-40	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69168-328-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69168-328-13	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69168-328-13	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69168-328-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69168-328-40	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69168-328-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
Brand name suffix: Extra Strength
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
8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69168-328-01	2020-12-07	Drug Facts
69168-328-03	2020-12-07	Drug Facts
69168-328-13	2020-12-07	Drug Facts
69168-328-40	2020-12-07	Drug Facts
69168-328-01	2020-01-31	Drug Facts
69168-328-03	2020-01-31	Drug Facts
69168-328-13	2020-01-31	Drug Facts
69168-328-40	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-328-01	Pain ReliefExtra Strength	100 in 1 CARTON	TABLET	100	10
69168-328-03	Pain ReliefExtra Strength	250 in 1 BOTTLE	TABLET	250	10
69168-328-13	Pain ReliefExtra Strength	175 in 1 BOTTLE	TABLET	175	10
69168-328-40	Pain ReliefExtra Strength	40 in 1 CARTON	TABLET	40	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-328	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]	10	Current NDC, Legacy NDC, 4 package rows	20231115_8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7.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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Rapid Relief	ACETAMINOPHEN	Haleon US Holdings LLC	3a36b7ca-396e-cfd8-e063-6294a90a76ab	2026-02-22	Warnings	Exact identifier application number: M013
CHILDRENS Acetaminophen	CHILDRENS ACETAMINOPHEN	Kesin Pharma Corporation	4af5b025-1fd7-e825-e063-6294a90aa005	2026-02-16	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	4a121a53-dbae-05c7-e063-6294a90aed89	2026-02-13	Warnings	Exact identifier application number: M013
MAX relief junior Grape	CHILDRENS ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	562d7901-44d6-4d9b-be8b-a8d468a22c43	2026-02-13	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	020fa486-31f0-4e0c-84d3-5b3aaded1eeb	2026-02-13	Warnings	Exact identifier application number: M013
ASPIRIN Low Strength	ASPIRIN	CVS Pharmacy	6e1c1129-562b-4a8a-ac37-db3cb2a82735	2026-02-11	Warnings	Exact identifier application number: M013
CVS Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	3dd21aaf-13b2-9e81-e063-6294a90afaec	2026-02-11	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE	CVS Pharmacy	ddd78b28-6e10-4708-bed1-8aea087b3d82	2026-02-11	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Topco Associates, LLC	2e31fe65-5f50-455b-99fa-c72879f43545	2026-02-10	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	Amerisource Bergen	9ea8bb1f-1924-4430-98bd-f2674d0da748	2026-02-09	Warnings	Exact identifier application number: M013
Acetaminophen , Caffeine and pyrilamine maleate	ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE	Softgel Healthcare Pvt Ltd	4a61313e-1b48-29df-e063-6394a90a27f0	2026-02-09	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	L. Perrigo Company	e9fddbc1-11fe-4cf6-8794-1650fa1b32ae	2026-02-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	2d375ec9-a528-4048-a15b-652fa20e74a7	2026-02-06	Warnings	Exact identifier application number: M013
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Sportpharm LLC	d3379569-7949-4f78-b634-5d4178b21ea4	2026-02-06	Warnings	Exact identifier application number: M013
Buffered Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	e5f68c1a-21f3-45a1-861f-229a95b3721c	2026-02-06	Warnings	Exact identifier application number: M013
pain relief extra strength	ACETAMINOPHEN	HyVee Inc	1e707628-08b1-4c72-b71c-2b4ae96071f2	2026-02-06	Warnings	Exact identifier application number: M013
CareOne Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	American Sales Company	2d2ded37-f241-4976-886d-5c038a85bfe1	2026-02-05	Warnings	Exact identifier application number: M013
Dolex Fem	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pharmadel LLC	b1cab10b-19f1-f5d5-e053-2995a90a4d5f	2026-02-05	Warnings	Exact identifier application number: M013
Alka-Seltzer Extra Strength Pain Relief	ANHYDROUS CITRIC ACID, ASPIRIN	Bayer HealthCare LLC.	4a16b6e5-f0c6-e3a4-e063-6294a90a85ad	2026-02-05	Warnings	Exact identifier application number: M013
Pain Relief childrens	ACETAMINOPHEN	CVS PHARMACY	b8ab85a6-3eab-4ef4-a13d-5ac300480f63	2026-02-03	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	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	10
198440	acetaminophen 500 MG Oral Tablet	SCD	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	10
198440	APAP 500 MG Oral Tablet	SY	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-328-01	69168032801	100 TABLET in 1 CARTON (69168-328-01)	100 tablet	2014-12-17	0000-00-00	No	No	Current
69168-328-03	69168032803	250 TABLET in 1 BOTTLE (69168-328-03)	250 tablet	2014-12-17	0000-00-00	No	No	Current
69168-328-13	69168032813	175 TABLET in 1 BOTTLE (69168-328-13)	175 tablet	2014-12-17	0000-00-00	No	No	Current
69168-328-40	69168032840	40 TABLET in 1 CARTON (69168-328-40)	40 tablet	2014-12-17	0000-00-00	No	No	Current