Pain Reliever

Product NDC: 0363-0175
11-digit product format: 003630175
Labeler code: 0363
Product ID: 0363-0175_9b25babe-5e4e-459f-ac51-6515648f3587
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Walgreen Company
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0363-0175	0363-0175-08	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-12	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-14	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-15	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-20	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-29	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-37	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-57	D	Discontinued by firm	2026-10-23
excluded package	package	0363-0175	0363-0175-99	D	Discontinued by firm	2026-10-23

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 2 · 104 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	0363-0175-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-29	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0175-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0175-29	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0175-29	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0175-29	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0175-29	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0175-29	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0175-57	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0175-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0175-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0175-37	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0175-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0175-99	`302b2466d912…`	`e7b80fea0513…`

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
f7667529-09c0-4603-8080-f236144fac36	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0175-03	Pain RelieverExtra Strength	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	25
0363-0175-08	Pain RelieverExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	24	25
0363-0175-08	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-12	Pain RelieverExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	25
0363-0175-12	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-14	Pain RelieverExtra Strength	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	25
0363-0175-15	Pain RelieverExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	25
0363-0175-15	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-20	Pain RelieverExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	225	25
0363-0175-20	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-29	Pain RelieverExtra Strength	150 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	150	25
0363-0175-37	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-37	Pain RelieverExtra Strength	75 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	75	25
0363-0175-57	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-57	Pain RelieverExtra Strength	125 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	125	25
0363-0175-99	Pain RelieverExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	25
0363-0175-99	Pain RelieverExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	24	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0175-08	EA - Each	0363-0175	1785b67f-dae5-4bd7-bf49-2a18c917a43e	1	2012-07-24
0363-0175-12	EA - Each	0363-0175	080c808e-3a8b-4c5a-af0b-4434d903ebe4	1	2012-07-24
0363-0175-14	EA - Each	0363-0175	f746f447-21e4-460f-9c02-1cd1136c4b16	1	2012-07-24
0363-0175-15	EA - Each	0363-0175	7ab0b567-db1d-444e-81aa-21757e7a18cf	1	2012-07-24
0363-0175-20	EA - Each	0363-0175	42a2211c-bd60-46b4-8d2b-42ceba0f637b	1	2024-04-05
0363-0175-29	EA - Each	0363-0175	2ae5278f-300e-48a0-851e-4d1feb4cb916	1	2012-07-24
0363-0175-37	EA - Each	0363-0175	3d03849d-5174-498a-8e5c-3e4507212a04	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN CO.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0175	PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN COMPANY]	24	Current NDC, Legacy NDC, 17 package rows	20250108_f7667529-09c0-4603-8080-f236144fac36.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 79 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief PM Extra Strength	ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	423a8445-964c-4cdb-889a-f391ca5253e7	2018-12-31	Warnings	Exact identifier application number: M013
Cold Multi-Symptom Night-time	ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI	Allegiant Health	3f020cf2-6011-4216-9b39-0b3dc5f0749c	2018-12-26	Warnings	Exact identifier application number: M013
Aspirin Chewable	ASPIRIN 81 MG	Allegiant Health	92b8637b-03a9-461f-b2f6-6eddaa214953	2018-12-21	Warnings	Exact identifier application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Allegiant Health	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	2018-12-21	Warnings	Exact identifier application number: M013
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Exact identifier application number: M013
ASPIRIN Enteric Coated	ASPIRIN 81 MG	Allegiant Health	5910a882-eb40-440f-8a30-c21fbce9050e	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN 325 MG	Allegiant Health	88b54062-8b3d-4024-a957-62b3255184b9	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5	2018-11-07	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier application number: M013
SED-MAX	ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG	Command Brands, LLC	4920a0e9-6f88-4df0-8657-77c95a3b9617	2017-01-19	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	f7667529-09c0-4603-8080-f236144fac36	25
198440	acetaminophen 500 MG Oral Tablet	SCD	f7667529-09c0-4603-8080-f236144fac36	25
198440	APAP 500 MG Oral Tablet	SY	f7667529-09c0-4603-8080-f236144fac36	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0175-03	00363017503	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-03)	1993-04-02	0000-00-00	No	No	Current
0363-0175-08	00363017508	1 BOTTLE, PLASTIC in 1 CARTON (0363-0175-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
0363-0175-12	00363017512	1 BOTTLE, PLASTIC in 1 CARTON (0363-0175-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
0363-0175-14	00363017514	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-14)	1993-04-02	0000-00-00	No	No	Current
0363-0175-15	00363017515	1 BOTTLE, PLASTIC in 1 CARTON (0363-0175-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
0363-0175-20	00363017520	1 BOTTLE, PLASTIC in 1 CARTON (0363-0175-20) > 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current
0363-0175-29	00363017529	150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0175-29)	1993-04-02	0000-00-00	No	No	Current
0363-0175-37	00363017537	1 in 1 CARTON					Historical
0363-0175-57	00363017557	1 in 1 CARTON					Historical
0363-0175-99	00363017599	1 BOTTLE, PLASTIC in 1 CARTON (0363-0175-99) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1993-04-02	0000-00-00	No	No	Current