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 36 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEXACLEAR PAIN RELIEVER	CAFFEINE, CHOLINE SALICYLATE	GM Pharmaceuticals, INC	065bd10c-3bcf-486f-a49c-40544127007f	2025-10-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	ASCLEMED USA INC.	db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	2025-10-14	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	fa33f6ef-522b-4630-9716-92371d9cd24a	2025-10-14	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Rite Aid Corporation	a8bb4f45-7a1a-4bf7-92ca-3afd508032f3	2025-10-09	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Health Pharma USA LLC	b15a7dcb-f143-4aea-8850-d0aacbf709b6	2025-10-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	3f96aeb1-a533-4d36-9a1f-62fc094b6754	2025-10-08	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Walgreens	f2eb9575-d527-44c7-aa5e-efabfd9a0278	2025-10-07	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	bbc704e5-79f6-4c72-846b-cc30c5c43cb4	2025-10-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	f1ce15a3-9824-4eb5-910a-39078165f385	2025-10-07	Warnings	Exact identifier application number: M013
BupropiDex	DEXTROMETHORPHAN HYDROBROMIDE	DXM Pharmacuetical, Inc.	90cc9bcd-7891-4324-a1f4-f6df7a0457e0	2025-10-06	Warnings	Exact identifier application number: M013
Dextabs	DEXTROMETHORPHAN HYDROBROMIDE	DXM Pharmacuetical, Inc.	71b567df-844a-4563-b85a-f4592233f37d	2025-10-06	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin and Caffeine	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Rising Pharma Holdings, Inc.	50f72713-50f5-4bab-9e96-b9fa73c9df1f	2025-10-06	Warnings	Exact identifier application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL	ACETAMINOPHEN 160 MG / 5 ML	MEDWISE LIFESCIENCES INC.	40507559-aee4-a603-e063-6394a90afc4f	2025-10-04	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	004c39cd-b4f4-1cae-e063-6394a90a0697	2025-10-03	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Family Dollar (FAMILY WELLNESS)	43573e35-6776-446e-aa28-75c8edc5b98d	2025-10-03	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Family Dollar (FAMILY WELLNESS)	f8e5fab4-1212-4c60-a160-9b782f76a198	2025-10-03	Warnings	Exact identifier application number: M013
CVS Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	3d71a0aa-5e03-0bdc-e063-6294a90a6634	2025-10-02	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	cc865351-34e8-4e8e-b8bf-23336c45bc61	2025-10-02	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Bryant Ranch Prepack	8e40f8f1-03c5-444b-8b5e-4532c3146e47	2025-10-02	Warnings	Exact identifier application number: M013
ASPIRIN 325 MG EC	ASPIRIN	Proficient Rx LP	9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77	2025-10-01	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