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	2026-10-12
excluded package	package	50844-175	50844-175-10	D	Discontinued by firm	2026-10-12
excluded package	package	50844-175	50844-175-94	D	Discontinued by firm	2026-10-12

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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	H E B	c713556c-cb9e-4ed2-bc2f-49b3d6256c0f	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Discount Drug Mart	4a1e9c79-5036-4c69-82f9-e48abc972b47	2026-04-02	Warnings	Exact identifier application number: M013
Wispirin	ASPIRIN	Wisdrug AG	4e70ec5e-d033-a525-e063-6394a90a5a93	2026-04-01	Warnings	Exact identifier application number: M013
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	ef2d75ee-9ed7-4b53-adbc-2ec40364da63	2026-03-31	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Hi-Tech Nutraceuticals, LLC	b119ba37-0ee3-851a-e053-2995a90a85b1	2026-03-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	RMT HEALTH LLC	4dc7229d-c895-1f80-e063-6394a90abfc3	2026-03-30	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	d1f05e56-c830-4f85-b685-2a5965d10a1c	2026-03-26	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	ad01aea6-4af3-469b-b99d-e1e66aa40e8d	2026-03-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Meijer Distribution Inc	c550b92e-de54-4599-9534-bd3022b0a86d	2026-03-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	AmerisourceBergen (Good Neighbor Pharmacy) 46122	db187226-0770-4934-90a4-c6ca50bdecef	2026-03-25	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	804d4b63-1bbe-47c0-ad49-39ddbeade6a3	2026-03-25	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	HyVee Inc	9d9c2bf6-8660-4987-8794-936d3102da8d	2026-03-24	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	BJWC (Berkley & Jensen / BJ's)	851228ea-eaf3-452b-a9ce-8cd244a0eaf3	2026-03-24	Warnings	Exact identifier application number: M013
FirstCare Childrens Pain Fever Acetaminophen	ACETAMINOPHEN 80 MG	USpharma Ltd	9fc05ba6-5667-457e-82c1-a8b4e16cadda	2026-03-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Aarkish Pharmaceuticals NJ Inc.	e5e9e1ce-666a-461f-8287-a4642902067c	2026-03-23	Warnings	Exact identifier application number: M013
Chewable Aspirin Low Dose	CHEWABLE ASPIRIN	Grocery Outlet	609c0389-8bed-4483-84fa-73ee73fdb4e4	2026-03-20	Warnings	Exact identifier application number: M013
Adult Low Dose Pain Reliever	ASPIRIN	TWIN MED LLC	a395acf4-f487-4c98-8c44-ca2aaaf72deb	2026-03-20	Warnings	Exact identifier application number: M013
Rapidol	ACETAMINOPHEN	Pharmadel LLC	3a210860-1fc1-e496-e063-6394a90a8705	2026-03-20	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