Tylenol Extra Strength

Product NDC: 67751-167
11-digit product format: 677510167
Labeler code: 67751
Product ID: 67751-167_2385e645-881c-5dd8-e063-6394a90adfab
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Navajo Manufacturing Company Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-09-22
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67751-167	67751-167-04	D	Discontinued by firm		2026-10-12
excluded package	package	67751-167	67751-167-03	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 · 30 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
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67751-167-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67751-167-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67751-167-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67751-167-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67751-167-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67751-167-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67751-167-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67751-167-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67751-167-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67751-167-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67751-167-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67751-167-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67751-167-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67751-167-04	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67751-167-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67751-167-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67751-167-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67751-167-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67751-167-03	`9bebd1f3094a…`	`5416666fcb17…`

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: Tylenol 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198440	Internal RxNorm lookup
209459	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
86b6ac01-3866-4cd8-a1be-9babb6ff311b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
67751-167-01	2024-04-17	d6a99b39-4b62-a426-e053-dadaa90af4c2	Tylenol Extra Strength
67751-167-02	2024-04-17	d6a99b39-4b62-a426-e053-dadaa90af4c2	Tylenol Extra Strength
67751-167-03	2024-04-17	9d75b9cf-e68d-f424-e053-dadaa90a57ce	Tylenol Extra Strength
67751-167-04	2024-04-17	d6a99b39-4b62-a426-e053-dadaa90af4c2	Tylenol Extra Strength
67751-167-01	2022-01-28	d6a99b39-4b62-a426-e053-dadaa90af4c2	Tylenol Extra Strength
67751-167-02	2022-01-28	d6a99b39-4b62-a426-e053-dadaa90af4c2	Tylenol Extra Strength
67751-167-04	2022-01-28	d6a99b39-4b62-a426-e053-dadaa90af4c2	Tylenol Extra Strength
67751-167-03	2020-01-31	9d75b9cf-e68d-f424-e053-dadaa90a57ce	Tylenol Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-167-01	Tylenol Extra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	6
67751-167-01	Tylenol Extra Strength	2 in 1 POUCH	TABLET, FILM COATED	2	6
67751-167-02	Tylenol Extra Strength	4 in 1 POUCH	TABLET, FILM COATED	4	6
67751-167-02	Tylenol Extra Strength	1 in 1 CARTON	TABLET, FILM COATED	1	6
67751-167-04	Tylenol Extra Strength	12 in 1 TRAY	TABLET, FILM COATED	12	6
67751-167-04	Tylenol Extra Strength	1 in 1 POUCH	TABLET, FILM COATED	1	6
67751-167-03	Tylenol Extra Strength	12 in 1 TRAY	TABLET, FILM COATED	12	2
67751-167-03	Tylenol Extra Strength	2 in 1 POUCH	TABLET, FILM COATED	2	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-167	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]	6	Current NDC, Legacy NDC, 6 package rows	20241004_86b6ac01-3866-4cd8-a1be-9babb6ff311b.zip
67751-167	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240418_65bf1556-f25a-9439-e053-2a91aa0a3194.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 54 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NOTTS - Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	e6754f62-e3b2-773f-e053-2a95a90ad36a	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	a891896d-c9fa-4448-915a-e6b531157d22	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	SAFEWAY	d2d15e06-e9eb-3d2b-e053-2995a90a1cec	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	TopCo Associates LLC	c2d33352-431c-4683-a4fa-a54437e7b8d2	2024-12-02	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	TopCo Associates LLC	bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Adult Low Dose	ASPIRIN	TopCare	14d010fb-c4a1-4c3d-942f-58719727bfc0	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CVS Pharmacy, Inc	c4473ee6-4e01-1ec2-e053-2995a90ac513	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Proficient Rx LP	9c186289-e309-45e8-8934-1d0eae0375c2	2024-12-01	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	22f63d62-c941-5b8f-e063-6394a90aeecd	2024-11-28	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a7b6318-b7d6-31b1-e053-2991aa0abf25	2024-11-28	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	INGLES MARKETS, INC.	27fd288e-c07a-617f-e063-6394a90a17a4	2024-11-28	Warnings	Exact identifier application number: M013
BAYER Aspirin Original, TRAVEL BASIX	ASPIRIN	Lil' Drug Store Products, Inc.	7f5d9ebe-8119-49a2-9380-eca18a5e5e85	2024-11-27	Warnings	Exact identifier application number: M013
EXCEDRIN MIGRAINE	ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE	Jones Healthcare Group - Packaging Services, Inc	c4168e4d-3dfc-4e51-a32e-14704cb59c66	2024-11-27	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief	ACETAMINOPHEN, LIDOCAINE, MENTHOL	Kenvue Brands LLC	2611e984-0dd5-bda1-e063-6394a90a559a	2024-11-26	Warnings	Exact identifier application number: M013
First Aid Only Extra-Strength Non-Aspirin	ACETAMINOPHEN	Acme United Corporation	6891d57a-10a6-53de-e053-2a91aa0ac7c2	2024-11-26	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	MARC GLASSMAN, INC.	c8314910-71ff-5a55-e053-2995a90aafc7	2024-11-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Marc Glassman, Inc.	7990ca49-fb30-40fe-9ac4-48e89eac9bb2	2024-11-26	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin Regular Strength	ASPIRIN	Safeway	96359eb6-62bc-4b13-960c-050af99a8c02	2024-11-26	Warnings	Exact identifier application number: M013
ASPIRIN Low Dose	ASPIRIN	Marc Glassman, Inc.	3d519af3-9398-4439-8253-1e5d4612b8e3	2024-11-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	06eabf4b-f8c0-439a-acf1-aa6e3075c717	2024-11-25	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	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
198440	acetaminophen 500 MG Oral Tablet	SCD	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
198440	APAP 500 MG Oral Tablet	SY	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
209459	Tylenol 500 MG Oral Tablet	SY	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	86b6ac01-3866-4cd8-a1be-9babb6ff311b	6
198440	acetaminophen 500 MG Oral Tablet	PSN	65bf1556-f25a-9439-e053-2a91aa0a3194	2
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	65bf1556-f25a-9439-e053-2a91aa0a3194	2
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	65bf1556-f25a-9439-e053-2a91aa0a3194	2
198440	acetaminophen 500 MG Oral Tablet	SCD	65bf1556-f25a-9439-e053-2a91aa0a3194	2
198440	APAP 500 MG Oral Tablet	SY	65bf1556-f25a-9439-e053-2a91aa0a3194	2
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	65bf1556-f25a-9439-e053-2a91aa0a3194	2
209459	Tylenol 500 MG Oral Tablet	SY	65bf1556-f25a-9439-e053-2a91aa0a3194	2
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	65bf1556-f25a-9439-e053-2a91aa0a3194	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-167-01	67751016701	1 POUCH in 1 CARTON (67751-167-01) / 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2016-09-22	0000-00-00	No	No	Current
67751-167-02	67751016702	1 POUCH in 1 CARTON (67751-167-02) / 4 TABLET, FILM COATED in 1 POUCH	1 pouch	2016-09-22	0000-00-00	No	No	Current
67751-167-03	67751016703	12 in 1 TRAY						Historical
67751-167-04	67751016704	12 POUCH in 1 TRAY (67751-167-04) > 1 TABLET, FILM COATED in 1 POUCH	12 pouch	2016-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tylenol Extra Strength	Navajo Manufacturing Company Inc.	2024-10-02	HUMAN OTC DRUG LABEL	6
Tylenol Extra Strength	Navajo Manufacturing Company Inc. \| Navajo Manufacutring Company Inc.	2024-04-15	HUMAN OTC DRUG LABEL	2