Pain Relief

Product NDC: 36800-770
11-digit product format: 368000770
Labeler code: 36800
Product ID: 36800-770_286014c1-2183-fc25-e063-6394a90aa15e
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TopCo Associates LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-31
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	36800-770	36800-770-01	D	Discontinued by firm	2026-10-16
excluded package	package	36800-770	36800-770-03	D	Discontinued by firm	2026-10-16
excluded package	package	36800-770	36800-770-05	D	Discontinued by firm	2026-10-16
excluded package	package	36800-770	36800-770-12	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	36800-770-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-770-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-770-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-770-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-770-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-770-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-770-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-770-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-770-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-770-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-770-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-770-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-770-01	`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 Relief
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
ecd6df7e-e7e2-446b-85ef-25971281fe31	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-770-01	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-01	Pain ReliefExtra Strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	7
36800-770-02	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-02	Pain ReliefExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	7
36800-770-03	Pain ReliefExtra Strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	7
36800-770-03	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-05	Pain ReliefExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
36800-770-05	Pain ReliefExtra Strength	225 in 1 BOTTLE, PLASTIC	TABLET, COATED	225	7
36800-770-12	Pain ReliefExtra Strength	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-770	PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [TOPCO ASSOCIATES LLC]	7	Current NDC, Legacy NDC, 9 package rows	20241206_ecd6df7e-e7e2-446b-85ef-25971281fe31.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 59 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Regular Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e21e821c-9694-5db0-e053-2995a90ad034	2024-10-22	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	MARC GLASSMAN, INC.	e21e90e8-b9f1-1133-e053-2995a90a664b	2024-10-22	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Publix Super Markets Inc	c51dae48-aa49-4926-b04a-0da264e08dfa	2024-10-22	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	b96a2280-ec4f-7c61-e053-2995a90a18bb	2024-10-22	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	f17a18b0-a7c2-4c64-868c-460cf34e1f7d	2024-10-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	HEB	0863aeaa-15ec-4c67-ba79-4dad54555bd2	2024-10-21	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	American Health Packaging	3c0175a0-175b-48b8-9192-3f869690c0f2	2024-10-21	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	American Health Packaging	0d6553bd-3e18-4624-a83a-899bcafb3272	2024-10-21	Warnings	Exact identifier application number: M013
Childrens Acetaminophen Oral Suspension	ACETAMINOPHEN	American Health Packaging	8231dd91-e9e6-4350-a485-fa95d65a6d25	2024-10-21	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	KROGER COMPANY	cf63c372-acdd-6e6e-e053-2995a90a1662	2024-10-21	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	L. Perrigo Company	8b56bfc0-2253-458d-99a6-0b0f9ae0ba50	2024-10-21	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	GOODSENSE	662a2bc6-9507-465c-b467-7ae1b2e1dedc	2024-10-18	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	GoodSense	da4339c0-1822-41d8-8c20-214c379a5aa7	2024-10-18	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	GoodSense	8972d95a-51da-40b5-8ef1-9dfed220d7eb	2024-10-18	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	AmeriSource Bergen	d571f520-a56e-4f7f-9214-d89197f742b6	2024-10-18	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	6b4b7f72-dac8-4b59-a58c-7c59d4b1ef32	2024-10-18	Warnings	Exact identifier application number: M013
dg health pain relief	ACETAMINOPHEN	Dolgencorp Inc	2e1470f5-e88f-4d1d-a308-170f7080387e	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	146c735b-5081-4de4-9025-d939d560bbba	2024-10-17	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	DISCOUNT DRUG MART	c8483d64-874c-3056-e053-2995a90ad8aa	2024-10-17	Warnings	Exact identifier application number: M013
Adult Chewable Aspirin	ASPIRIN	DISCOUNT DRUG MART	c8484998-e0e1-ffce-e053-2995a90aa7de	2024-10-17	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	ecd6df7e-e7e2-446b-85ef-25971281fe31	7
198440	acetaminophen 500 MG Oral Tablet	SCD	ecd6df7e-e7e2-446b-85ef-25971281fe31	7
198440	APAP 500 MG Oral Tablet	SY	ecd6df7e-e7e2-446b-85ef-25971281fe31	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-770-01	36800077001	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	0000-00-00	No	No	Current
36800-770-02	36800077002	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	0000-00-00	No	No	Current
36800-770-03	36800077003	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	0000-00-00	No	No	Current
36800-770-05	36800077005	1 BOTTLE, PLASTIC in 1 CARTON (36800-770-05) > 225 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-03-31	2022-09-30	No	No	Current
36800-770-12	36800077012	400 TABLET, COATED in 1 BOTTLE, PLASTIC (36800-770-12)	2016-01-01	2022-03-31	No	No	Current