Pain Relief

Product NDC: 69168-328
Requested package NDC: 69168-328-03
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		2026-08-03

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 · 14 matching rows.

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

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

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 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Acetaminophen 325 mg	ACETAMINOPHEN	NUVICARE LLC	49a59b79-b8b4-4bf5-a403-0a14751efc55	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Childrens Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	4f86419a-b940-a9c6-e063-6394a90a6a2b	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	5468b149-8fac-8d6a-e063-6294a90a8c51	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ba0a9f2-062a-401e-82eb-54383a822366	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable	ASPIRIN	Better Living Brands, LLC	7afce7b4-c86a-43f7-83cf-15ebffba2f35	2026-07-28	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	f818996c-36d2-4d3d-af3e-39949157edb9	2026-07-28	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	03b871e8-3e14-4ed8-a978-45129255b272	2026-07-27	Warnings	Exact identifier application number: M013
Pain Relief Acetaminophen PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Rite Aid Corporation	17d27771-a112-474f-9a58-29af0d7e1af3	2026-07-27	Warnings	Exact identifier application number: M013
Children Pain Relief Gummy	ACETAMINOPHEN CHILDREN GUMMY	Gummy USA	5513db67-f023-7f47-e063-6294a90a2757	2026-07-24	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	2143cc16-86db-4060-96da-5c228ae9207b	2026-07-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Softgel Healthcare Pvt Ltd	352bb451-ffdc-411a-e063-6294a90a8cf5	2026-07-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	fdb7331a-d029-8b2a-e053-6294a90adfcd	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	5ada044e-50e8-4874-ac04-df5f1f9e735d	2026-07-24	Warnings	Exact identifier application number: M013
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	a63727c3-64d8-4ae9-8da3-974cae6beed2	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e4a2566e-48ec-4602-87e3-143398d15f33	2026-07-24	Warnings	Exact identifier application number: M013
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	920e7055-7ed1-4db4-9215-f8933078bb7b	2026-07-24	Warnings	Exact identifier application number: M013
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	c6665c11-9a01-4472-a444-acadb1de0b69	2026-07-23	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	103d109d-f520-409c-8da2-eb6b0fbec891	2026-07-22	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	ce58105b-f010-47af-8f31-6dd4ce4e9cba	2026-07-22	Warnings	Exact identifier application number: M013
Vicks PainQuil PAIN RELIEVER	ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	0ad7b313-5d72-4cc0-97f0-1a30770350af	2026-07-22	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
69168-328-03	69168032803	250 TABLET in 1 BOTTLE (69168-328-03)	250 tablet	2014-12-17	0000-00-00	No	No	Current