Pain Reliever

Product NDC: 0363-0519
11-digit product format: 003630519
Labeler code: 0363
Product ID: 0363-0519_47a1e1b6-6aea-4562-8c40-bcf5bfe79e4c
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Walgreen Company
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0363-0519	0363-0519-19	D	Discontinued by firm	2026-10-16
excluded package	package	0363-0519	0363-0519-20	D	Discontinued by firm	2026-10-16
excluded package	package	0363-0519	0363-0519-29	D	Discontinued by firm	2026-10-16
excluded package	package	0363-0519	0363-0519-54	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 · 48 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	0363-0519-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0519-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0519-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0519-29	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0519-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0519-29	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0519-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0519-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0519-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0519-29	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0519-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0519-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0519-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0519-29	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0519-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0519-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0519-54	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0519-29	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0519-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0519-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0519-54	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0519-29	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0519-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0519-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0519-54	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0519-29	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0519-19	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0519-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0519-54	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0519-29	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0519-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0519-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0519-54	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0519-29	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0519-19	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0519-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0519-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0519-29	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0519-54	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0519-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0519-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0519-29	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0519-54	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0519-19	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0519-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0519-29	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0519-54	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0519-19	`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
fa33f6ef-522b-4630-9716-92371d9cd24a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0519-08	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	24
0363-0519-08	Pain RelieverExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	24
0363-0519-12	Pain RelieverExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	24
0363-0519-12	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	24
0363-0519-15	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	24
0363-0519-15	Pain RelieverExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	24
0363-0519-19	Pain RelieverExtra Strength	8 in 1 VIAL	TABLET, COATED	8	24
0363-0519-19	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	24
0363-0519-20	Pain RelieverExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, COATED	225	24
0363-0519-20	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	24
0363-0519-29	Pain RelieverExtra Strength	150 in 1 BOTTLE, PLASTIC	TABLET, COATED	150	24
0363-0519-37	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, COATED	1	24
0363-0519-37	Pain RelieverExtra Strength	75 in 1 BOTTLE, PLASTIC	TABLET, COATED	75	24
0363-0519-54	Pain RelieverExtra Strength	375 in 1 BOTTLE, PLASTIC	TABLET, COATED	375	24
0363-0519-92	Pain RelieverExtra Strength	150 in 1 BOTTLE, PLASTIC	TABLET, COATED	150	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0519-08	EA - Each	0363-0519	9a69870d-fdb2-4bc4-8a04-1bf8f981ae42	1	2012-07-24
0363-0519-12	EA - Each	0363-0519	3e513c0c-aedd-48d9-bcf5-603984d6f238	1	2012-07-24
0363-0519-15	EA - Each	0363-0519	beabd538-bc4f-4d80-a59a-8a7884e49924	1	2012-07-24
0363-0519-19	EA - Each	0363-0519	4dd1144b-a6a2-44da-a280-f0e95c923466	1	2012-07-24
0363-0519-20	EA - Each	0363-0519	ca07599c-a398-4321-be29-e16da39195a1	1	2012-07-24
0363-0519-29	EA - Each	0363-0519	3b4f0f1a-ebe6-4702-ba0b-70a0324c373a	1	2012-07-24
0363-0519-54	EA - Each	0363-0519	68c192ff-03d2-4c02-a129-310a1134b99a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [WALGREEN CO.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0519	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WALGREEN COMPANY]	23	Current NDC, Legacy NDC, 15 package rows	20250104_fa33f6ef-522b-4630-9716-92371d9cd24a.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	fa33f6ef-522b-4630-9716-92371d9cd24a	24
198440	acetaminophen 500 MG Oral Tablet	SCD	fa33f6ef-522b-4630-9716-92371d9cd24a	24
198440	APAP 500 MG Oral Tablet	SY	fa33f6ef-522b-4630-9716-92371d9cd24a	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0519-08	00363051908	1 BOTTLE, PLASTIC in 1 CARTON (0363-0519-08) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC		2004-05-10	0000-00-00	No	No	Current
0363-0519-12	00363051912	1 BOTTLE, PLASTIC in 1 CARTON (0363-0519-12) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC		2004-05-10	0000-00-00	No	No	Current
0363-0519-15	00363051915	1 BOTTLE, PLASTIC in 1 CARTON (0363-0519-15) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC		2004-05-10	0000-00-00	No	No	Current
0363-0519-19	00363051919	8 in 1 VIAL						Historical
0363-0519-20	00363051920	1 BOTTLE, PLASTIC in 1 CARTON (0363-0519-20) > 225 TABLET in 1 BOTTLE, PLASTIC		2004-05-10	0000-00-00	No	No	Current
0363-0519-29	00363051929	150 TABLET in 1 BOTTLE (0363-0519-29)	150 tablet	2004-05-10	0000-00-00	No	No	Current
0363-0519-37	00363051937	1 BOTTLE, PLASTIC in 1 CARTON (0363-0519-37) / 75 TABLET, COATED in 1 BOTTLE, PLASTIC		2024-12-30		No	No	Current
0363-0519-54	00363051954	375 TABLET in 1 BOTTLE, PLASTIC (0363-0519-54)	375 tablet	2004-05-10	0000-00-00	No	No	Current
0363-0519-92	00363051992	150 TABLET, COATED in 1 BOTTLE, PLASTIC (0363-0519-92)		2004-05-10	0000-00-00	No	No	Current