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 39 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ULINE Aspirin	ASPIRIN	ULINE	9b2b053c-11e7-8169-e053-2995a90ae336	2025-09-09	Warnings	Exact identifier application number: M013
Green Guard Chewable Aspirin 81 mg	ASPIRIN	Unifirst First Aid Corporaiton	173a53ca-b6ea-2042-e063-6294a90a8437	2025-09-08	Warnings	Exact identifier application number: M013
Medique Products Chewable Low Dose Aspirin	ASPIRIN	Unifirst First Aid Corporation	17009501-674d-c839-e063-6294a90a59fa	2025-09-08	Warnings	Exact identifier application number: M013
Henry Schein Acetaminophen	ACETAMINOPHEN	Henry Schein, Inc.	a56a5ca1-578c-40cd-90cc-cc4c2dfec847	2025-09-08	Warnings	Exact identifier application number: M013
Henry Schein Acetaminophen	ACETAMINOPHEN	Henry Schein, Inc.	f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa	2025-09-08	Warnings	Exact identifier application number: M013
Green Guard Maximum Non-Aspirin	ACETAMINOPHEN	Unifirst First Aid Corporation	30f77d4d-839e-4d96-9f24-0254e6a47b81	2025-09-08	Warnings	Exact identifier application number: M013
Green Guard Extra Strength Pain Relief	ASPIRIN. CAFFEINE	Unifirst First Aid Corporation	e729319a-6a2c-bfe6-e053-2a95a90a4620	2025-09-08	Warnings	Exact identifier application number: M013
Medique APAP	ACETAMINOPHEN	Unifirst First Aid Corporation	04805d9c-d959-4870-a185-48b58a880880	2025-09-08	Warnings	Exact identifier application number: M013
Green Guard Maximum Strength Non-Aspirin	ACETAMINOPHEN	Unifirst First Aid Corporation	f77c9554-d1c2-1682-e053-6294a90ac572	2025-09-08	Warnings	Exact identifier application number: M013
Medique Back Pain Relief	MAGNESIUM SALICYLATE TETRAHYDRATE	Unifirst First Aid Corporation	e5563a0a-776a-83d4-e053-2a95a90a9500	2025-09-08	Warnings	Exact identifier application number: M013
MEDIQUE APAP Extra Strength	ACETAMINOPHEN	Unifirst First Aid Corporation	56822785-d5fb-4869-971e-5de637c2eda8	2025-09-08	Warnings	Exact identifier application number: M013
Medique Medi-Seltzer Pain Relief	ASPIFIN	Unifirst First Aid Corporation	3d593dee-b932-b611-e063-6294a90ad3b7	2025-09-08	Warnings	Exact identifier application number: M013
Medique Extra Strength APAP	ACETAMINOPHEN	Unifirst First Aid Corporation	f77f8ef5-4aa8-fa80-e053-6394a90a70c2	2025-09-08	Warnings	Exact identifier application number: M013
Medique Pain Off	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Unifirst First Aid Corporation	c2d7af6b-f477-2462-e053-2995a90aff0f	2025-09-08	Warnings	Exact identifier application number: M013
Medique Extra Strength Apap	ACETAMINOPHEN	Unifirst First Aid Corporation	14bcbaf9-76b6-f8ba-e063-6294a90a91f6	2025-09-08	Warnings	Exact identifier application number: M013
Crane Safety XS Non-Aspirin	ACETAMINOPHEN 500 MG	Crane Safety LLC	9626b3b2-c8ba-5a58-e053-2995a90a35c8	2025-09-08	Warnings	Exact identifier application number: M013
Thompson Aspirin	ASPIRIN	Thompson	9623d9c6-f241-bf4a-e053-2a95a90a4eb5	2025-09-08	Warnings	Exact identifier application number: M013
Thompson XS Pain Ache	ASPIRIN, CAFFEINE	Thompson Safety	e87c2874-2a95-6839-e053-2a95a90ad14b	2025-09-08	Warnings	Exact identifier application number: M013
Medique at Home APAP	ACETAMINOPHEN	Unifirst First Aid Corporation	b5582e23-5079-1f2b-e053-2a95a90ad800	2025-09-08	Warnings	Exact identifier application number: M013
Thompson Extra Strength Non-Aspirin	ACETAMINOPHEN	Thompson	f837c31f-24e5-a8df-e053-6394a90a0b36	2025-09-08	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