Pain Reliever

Product NDC: 50844-519
11-digit product format: 508440519
Labeler code: 50844
Product ID: 50844-519_9f5e3344-4f7b-4096-a4f0-929e140c175c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: L.N.K. International, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-05-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50844-519	50844-519-02	D	Discontinued by firm		2026-10-15
excluded package	package	50844-519	50844-519-15	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 · 13 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	50844-519-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	50844-519-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	50844-519-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	50844-519-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	50844-519-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	50844-519-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	50844-519-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	50844-519-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	50844-519-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	50844-519-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	50844-519-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	50844-519-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	50844-519-15	`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: 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
72babe91-2586-4f05-ae90-6debfd23aa5d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50844-519-02	Pain RelieverExtra Strength	12 in 1 BOTTLE, PLASTIC	TABLET, COATED	12	17
50844-519-02	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	17
50844-519-12	Pain RelieverExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	17
50844-519-15	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	17
50844-519-15	Pain RelieverExtra Strength	50 in 1 BOTTLE	TABLET, COATED	50	17
50844-519-20	Pain RelieverExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, COATED	225	17
50844-519-21	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	17
50844-519-21	Pain RelieverExtra Strength	16 in 1 BOTTLE, PLASTIC	TABLET, COATED	16	17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEVER EXTRA STRENGTH (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
50844-519	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.]	16	Current NDC, Legacy NDC, 8 package rows	20241109_72babe91-2586-4f05-ae90-6debfd23aa5d.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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	2024-07-02	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN	Discount Drug Mart Inc	1c35f394-a221-6531-e063-6394a90acb8a	2024-07-01	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wildman Business Group	cdbfcf14-8685-40a9-9778-a3b4329dc1ad	2024-07-01	Warnings	Exact identifier application number: M013
Back Pain Relief Extra Strength Doans	MAGNESIUM SALICYLATE	Wildman Business Group	2e17664f-a83f-48d1-8b2b-37f41eea65b6	2024-07-01	Warnings	Exact identifier application number: M013
Meijer Effervescent Pain Relief	ASPIRIN	Meijer Distribution Inc	17553911-e0fc-e355-e063-6394a90af7b8	2024-06-28	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4fb4f4b2-c238-4933-b874-08def3b34a28	2024-06-26	Warnings	Exact identifier application number: M013
good neighbor pharmacy pain and fever childrens	ACETAMINOPHEN	Amerisource Bergen	ca0833ef-837b-47dc-8676-e016af96622c	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	4a030c3e-8104-4a0a-98c5-6ab469451f20	2024-06-26	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	a426dd82-b2d6-405e-b0af-cfb1310a6e19	2024-06-26	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALMART INC. (see also Equate)	7d86a03f-74f4-4b24-b6a6-8747acfe905e	2024-06-26	Warnings	Exact identifier application number: M013
leader childrens pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	5bcc5da9-7e64-4308-a5be-2f47a8ca774d	2024-06-25	Warnings	Exact identifier application number: M013
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	NuCare Pharmaceuticals,Inc.	9e691264-d48a-6b48-e053-2995a90a9352	2024-06-20	Warnings	Exact identifier application number: M013
Aspirin	REGULAR STRENGTH ENTERIC COATED ASPIRIN	NuCare Pharmceuticals,Inc.	a0705f4f-55cb-214a-e053-2995a90aa680	2024-06-20	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG	Lil' Drug Store Products, Inc.	ee8e0e79-4da4-101f-e053-2a95a90a30a4	2024-06-19	Warnings	Exact identifier application number: M013
Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil' Drug Store Products, Inc.	b3a06e4b-0b31-4e2a-8dd1-9de85760477b	2024-06-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Meijer Distribution Inc	43c3fe72-a4ef-48a6-bc22-a644919c0c5c	2024-06-17	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	093182a6-3ed8-5a3f-e063-6294a90a354a	2024-06-14	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	093199be-e92a-6f60-e063-6294a90a8533	2024-06-14	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	RETAIL BUSINESS SERVICES , LLC.	09315a3d-bb2d-4f06-e063-6294a90a3bd3	2024-06-14	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	613bc633-0426-41a7-aea9-9ff56311b607	2024-06-13	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	72babe91-2586-4f05-ae90-6debfd23aa5d	17
198440	acetaminophen 500 MG Oral Tablet	SCD	72babe91-2586-4f05-ae90-6debfd23aa5d	17
198440	APAP 500 MG Oral Tablet	SY	72babe91-2586-4f05-ae90-6debfd23aa5d	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50844-519-02	50844051902	1 BOTTLE, PLASTIC in 1 CARTON (50844-519-02) > 12 TABLET, COATED in 1 BOTTLE, PLASTIC		2004-05-10	0000-00-00	No	No	Current
50844-519-12	50844051912	100 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-12)		2023-11-14		No	No	Current
50844-519-15	50844051915	1 BOTTLE in 1 CARTON (50844-519-15) > 50 TABLET in 1 BOTTLE	1 bottle	2004-05-10	0000-00-00	No	No	Current
50844-519-20	50844051920	225 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-20)		2023-11-14		No	No	Current
50844-519-21	50844051921	1 BOTTLE, PLASTIC in 1 CARTON (50844-519-21) / 16 TABLET, COATED in 1 BOTTLE, PLASTIC		2004-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Plus 44-519	L.N.K. International, Inc. \| LNK International, Inc.	2025-11-15	HUMAN OTC DRUG LABEL	17