Pain Relief

Product NDC: 36800-991
11-digit product format: 368000991
Labeler code: 36800
Product ID: 36800-991_44608f7f-377f-4006-9c9e-d154e3a45e10
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Topco Associates, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-01-30
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-991	36800-991-06	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
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
8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-991-06	Pain Relief	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	200	10
36800-991-15	Pain Relief	1 in 1 CARTON	TABLET, FILM COATED	1	10
36800-991-15	Pain Relief	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-991	PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]	9	Current NDC, Legacy NDC, 3 package rows	20240723_8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101.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 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAX relief junior	ACETAMINOPHEN	Akron Pharma Inc.	0e43b885-3843-4f11-9a53-02a38c228313	2026-08-31	Warnings	Exact identifier application number: M013
MAX relief junior	CHILDREN ACETAMINOPHEN	Akron Pharma Inc.	d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9	2026-08-31	Warnings	Exact identifier application number: M013
MAX relief junior Grape	CHILDREN ACETAMINOPHEN	Akron Pharma Inc.	3c7a7f40-4963-4fd1-942e-93fa08a45830	2026-08-31	Warnings	Exact identifier application number: M013
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5a615118-33c9-1520-e063-6394a90a21a6	2026-08-31	Warnings	Exact identifier application number: M013
acetaminophen extra strength	ACETAMINOPHEN	Sam's West Inc	dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d	2026-08-28	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	HAWAII REPACK, INC.	ac94cce3-9a39-41de-bb8b-10a5e5b8e83b	2026-08-28	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	WinCo Foods, LLC	a0a19cd1-eb8a-4773-be00-78de90d2a3c3	2026-08-28	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	FSA STORE INC.	5502ef15-9f40-db56-e063-6394a90a2de4	2026-08-26	Warnings	Exact identifier application number: M013
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d	2026-08-26	Warnings	Exact identifier application number: M013
HyVee Extra Strength Headache Relief CAPLET	ACETAMINOPHEN, ASPIRIN, CAFFEINE	HyVee Inc	495c75bf-c09a-accd-e063-6294a90a75ec	2026-08-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Walgreens	543f93d1-df14-0bd2-e063-6294a90a4413	2026-08-24	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	ab79fd60-8315-4c63-8045-1b0511ac268f	2026-08-24	Warnings	Exact identifier application number: M013
Genexa Infants Pain and Fever	ACETAMINOPHEN	Genexa Inc.	4fd048c3-70bc-2ea7-e063-6394a90a55f2	2026-08-22	Warnings	Exact identifier application number: M013
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	59adabeb-97e8-2de4-e063-6394a90acc47	2026-08-22	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Publix Super Markets Inc	a876daa7-ade3-497d-87bb-46d6e4dc185a	2026-08-21	Warnings	Exact identifier application number: M013
equate aspirin	ASPIRIN	Wal-Mart Stores Inc	ea3f8eed-7b70-4156-9586-125d27bf29a8	2026-08-19	Warnings	Exact identifier application number: M013
aspirin chewable, low dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	6a6ac7fe-91a4-4b55-979a-b53b51505d8b	2026-08-19	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Sam's West Inc	1098d0e7-8202-4018-a2d2-b0c80ee58b56	2026-08-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Safeway, Inc.	5e77dca4-2ff8-4a8c-94bd-f224b680ca23	2026-08-19	Warnings	Exact identifier application number: M013
dg health pain relief pm extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Dolgencorp Inc	4d1eddf0-eff7-4c47-b312-30dee08d9e5f	2026-08-19	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	8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101	10
198440	acetaminophen 500 MG Oral Tablet	SCD	8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101	10
198440	APAP 500 MG Oral Tablet	SY	8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-991-06	36800099106	200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-991-06)	2019-01-30	2022-09-02	No	No	Current
36800-991-15	36800099115	1 BOTTLE, PLASTIC in 1 CARTON (36800-991-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2019-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare 44-531	Topco Associates, LLC \| LNK International, Inc.	2026-08-12	HUMAN OTC DRUG LABEL	12