Pain Reliever

Product NDC: 50844-175
11-digit product format: 508440175
Labeler code: 50844
Product ID: 50844-175_195fd310-b148-478a-aad5-2894a0ace24c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: L.N.K. International, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1993-04-02
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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	50844-175	50844-175-08	D	Discontinued by firm	2026-10-15
excluded package	package	50844-175	50844-175-10	D	Discontinued by firm	2026-10-15
excluded package	package	50844-175	50844-175-94	D	Discontinued by firm	2026-10-15

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 · 28 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	50844-175-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50844-175-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	50844-175-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	50844-175-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	50844-175-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	50844-175-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	50844-175-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	50844-175-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	50844-175-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	50844-175-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	50844-175-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	50844-175-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	50844-175-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	50844-175-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	50844-175-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	50844-175-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	50844-175-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	50844-175-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	50844-175-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	50844-175-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	50844-175-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	50844-175-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	50844-175-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	50844-175-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	50844-175-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	50844-175-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	50844-175-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	50844-175-12	`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 Reliever
Brand name suffix: Extra Strength
Listing expiration: 2027-12-31

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
8fed703a-9de2-4c76-a783-fcf004f9b890	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50844-175-08	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	14
50844-175-08	Pain RelieverExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	24	14
50844-175-10	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	14
50844-175-10	Pain RelieverExtra Strength	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	14
50844-175-12	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	14
50844-175-12	Pain RelieverExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	14
50844-175-94	Pain RelieverExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50844-175	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	14	Current NDC, Legacy NDC, 7 package rows	20250116_8fed703a-9de2-4c76-a783-fcf004f9b890.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 40 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique at Home APAP Extra Strength	ACETAMINOPHEN 500 MG	Unifirst First Aid Corporation	b56b4110-fb8f-e5a0-e053-2995a90a0ad3	2025-09-08	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	64c642b7-ef83-44b7-a014-6fa248dff3ba	2025-09-08	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE	BJWC (Berkley & Jensen / BJ's)	2f473f1f-7cf3-2af5-e063-6394a90aaa17	2025-09-01	Warnings	Exact identifier application number: M013
foster and thrive rapid release pain relief	ACETAMINOPHEN	Strategic Sourcing Services LLC	d2130173-b107-4ae6-a1f7-6db467da3820	2025-08-30	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	e1d4f562-433c-4344-9b77-1a7c731d1be5	2025-08-29	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated Low Dose	ASPIRIN	Walgreen Company	b11a4c4e-374c-403e-a757-5e9700f9f03b	2025-08-27	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Safeway	0e0a73f9-8c18-41fd-812e-8be20287e77a	2025-08-26	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	577035a5-88ab-431c-8598-7a19dd633fe9	2025-08-26	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Sixarp, LLC	2e20be17-2b6c-1a07-e063-6394a90acdd3	2025-08-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	2f32b096-d29a-c7c7-e063-6294a90a2bbe	2025-08-22	Warnings	Exact identifier application number: M013
Medique Medi Seltzer	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Unifirst First Aid Corporation	528da9d9-2a52-4c16-b7b2-61b3eee1abea	2025-08-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Publix Super Markets Inc	6b691dc1-09e4-46d3-b199-8917e42848a6	2025-08-19	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	P & L Development, LLC	59eb14a5-40b0-4331-beb5-7166e6cdf411	2025-08-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	4005f8dd-3050-4590-8703-6997444e8df3	2025-08-13	Warnings	Exact identifier application number: M013
good sense headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	4cae0580-7ee3-4f38-8d13-79c7d7615f8f	2025-08-12	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Exact identifier application number: M013
Dr Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Farmacias De Similares TX LLC	3c19ad99-6e0f-3116-e063-6394a90a914c	2025-08-11	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	8fed703a-9de2-4c76-a783-fcf004f9b890	14
198440	acetaminophen 500 MG Oral Tablet	SCD	8fed703a-9de2-4c76-a783-fcf004f9b890	14
198440	APAP 500 MG Oral Tablet	SY	8fed703a-9de2-4c76-a783-fcf004f9b890	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50844-175-08	50844017508	1 BOTTLE, PLASTIC in 1 CARTON (50844-175-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
50844-175-10	50844017510	1 BOTTLE, PLASTIC in 1 CARTON (50844-175-10) > 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
50844-175-12	50844017512	1 BOTTLE, PLASTIC in 1 CARTON (50844-175-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
50844-175-94	50844017594	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-175-94)	1993-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pain Reliever	L.N.K. International, Inc. \| LNK International, Inc.	2026-01-07	HUMAN OTC DRUG LABEL	15