EXTRA STRENGTH ACETAMINOPHEN

Product NDC: 49483-697
11-digit product format: 494830697
Labeler code: 49483
Product ID: 49483-697_2dc52443-77b2-5143-e063-6394a90a4958
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-02-11
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-697-43	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-697-43	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-697-43	`0efc9e666f02…`	`f202fb6c5f17…`

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: EXTRA STRENGTH ACETAMINOPHEN
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
c9f80d24-bd05-e1ce-e053-2995a90aa646	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49483-697-43	2025-02-10	C162847	48780-1	2cef2736-7a6f-d83d-e063-dadaa90ab31f	697R Timely 49483-697 Extra Strength Acetaminophen 500 mg Rapid Release 400 count
49483-697-43	2025-01-30	C162847	48780-1	2cef2736-7a6f-d83d-e063-dadaa90ab31f	697R Timely 49483-697 Extra Strength Acetaminophen 500 mg Rapid Release 400 count

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49483-697-43	EXTRA STRENGTH ACETAMINOPHEN	400 in 1 BOTTLE	TABLET	400		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-697	EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [TIME CAP LABORATORIES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250212_c9f80d24-bd05-e1ce-e053-2995a90aa646.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 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6	2026-07-02	Warnings	Exact identifier application number: M013
pain relief EXTRA STRENGTH	ACETAMINOPHEN	Meijer Distribution, Inc.	ae84eb7e-a70b-4311-b2dc-ad153047a516	2026-07-01	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	Hi-Tech Nutraceuticals, LLC	b3426a9a-ea99-da30-e053-2995a90a1e4b	2026-07-01	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Salado Sales, Inc.	ca21d576-be3c-495d-9dbd-ed514bf65da7	2026-07-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Meijer Distribution Inc	4e08a7cb-3894-84c3-e063-6394a90a0b42	2026-06-30	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Wal-Mart Stores Inc	9b1201af-c802-4e19-b192-bbbf34367db4	2026-06-30	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	fc841cba-8f4f-407b-97de-0422977515bd	2026-06-30	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	United Natural Foods, Inc. dba UNFI	b6ff2b34-51ee-41bc-8b7d-7520ade0bf36	2026-06-30	Warnings	Exact identifier application number: M013
Medline	ASPIRIN	Medline Industries, LP	4b0c569a-ed7a-e104-e063-6394a90a6d54	2026-06-29	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	e50b3f60-b827-426c-8e78-8447c89130fe	2026-06-29	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Chain Drug Marketing Association, Inc.	e58417f4-3575-4433-ac2e-b7bf9fe8ba10	2026-06-29	Warnings	Exact identifier application number: M013
Dr Kids Pain and Fever	ACETAMINOPHEN	CalmCo LLC	5534a784-a7b1-5599-e063-6294a90a7961	2026-06-27	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Select Consumer Group LLC	529d3a51-a248-7c02-e063-6294a90a10ae	2026-06-27	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Sportpharm LLC	830ffcaa-7ff8-4732-bc84-6a8c5e78722d	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Strategic Sourcing Services LLC	ea2ef485-429e-4c63-ba7b-0a6b32892ad2	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	055d8420-c189-4a9e-acdc-21627935c8eb	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Topco Associates, LLC	5f32cf74-dbea-496c-ba23-2040ea354f40	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Salado Sales, Inc.	cf3139a5-e36e-48e3-bb6c-e102b0cec555	2026-06-25	Warnings	Exact identifier application number: M013
Pain Relief Aspirin	ASPIRIN	Rite Aid Corporation	bd69d3d2-5d38-47c6-98a6-124f7a43b8b0	2026-06-25	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	Walgreen Company	0b27c0fd-7ea8-4588-9169-5ad4e8df77ef	2026-06-25	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	c9f80d24-bd05-e1ce-e053-2995a90aa646	3
198440	acetaminophen 500 MG Oral Tablet	SCD	c9f80d24-bd05-e1ce-e053-2995a90aa646	3
198440	APAP 500 MG Oral Tablet	SY	c9f80d24-bd05-e1ce-e053-2995a90aa646	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-697-43	49483069743	400 TABLET in 1 BOTTLE (49483-697-43)	400 tablet	2022-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EXTRA STRENGTH ACETAMINOPHEN	TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2025-02-10	HUMAN OTC DRUG LABEL	3