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 69 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KOSHER MEDS Childrens Pain and Fever	ACETAMINOPHEN	Mollec Inc	4d01c9ee-26be-4cdd-b52d-7fa344c1933a	2024-05-15	Warnings	Exact identifier application number: M013
Kosher Meds Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Mollec Inc	42ad618b-d2e5-4c58-9407-386df4fe4004	2024-05-15	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	P & L Development, LLC	1c081a7c-8cff-4253-97ac-5fa74a5c0668	2024-05-10	Warnings	Exact identifier application number: M013
dg health childrens pain and fever	ACETAMINOPHEN	Dolgencorp Inc	1d794621-9836-4ab8-92ee-fcd916964567	2024-05-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	76cb8209-6c43-322e-e053-2991aa0a51eb	2024-05-08	Warnings	Exact identifier application number: M013
Aspirin 81mg Dye-Free	ASPIRIN 81MG	Allegiant Health	26ad090d-7193-45c2-82eb-a2bc81955fe6	2024-05-08	Warnings	Exact identifier application number: M013
basic care infants pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	40329d8c-eb3d-4143-b4ae-9bafd0a1cb3c	2024-05-08	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	Walgreen Company	928bb80e-2e14-488c-99ab-abb860cbe7a8	2024-05-07	Warnings	Exact identifier application number: M013
basic care childrens pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	790d8883-52be-46f2-9838-564b6c5d57f9	2024-05-07	Warnings	Exact identifier application number: M013
Rugby Childrens Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	304a9aa2-9198-44ca-8627-d41b84ec6cbf	2024-05-07	Warnings	Exact identifier application number: M013
careone childrens acetaminophen	ACETAMINOPHEN	American Sales Company	808f4790-cadd-4285-ae70-25eb547137e2	2024-05-07	Warnings	Exact identifier application number: M013
Basic Care Childrens Pain and Fever	ACETAMINOPHEN	Amazon.com Services LLC	bf8bed5d-7dd4-492c-98ac-c36ff8be8f41	2024-05-06	Warnings	Exact identifier application number: M013
Basic Care Childrens Pain and Fever	ACETAMINOPHEN	Amazon.com Services LLC	0c133707-a8b8-4105-82f3-e3855ec19617	2024-05-06	Warnings	Exact identifier application number: M013
leader infants pain and fever	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	cfbb8553-f3ac-437d-8f63-caa93f257a77	2024-05-06	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	a272bf44-54df-448a-8bff-e31f9488b416	2024-05-06	Warnings	Exact identifier application number: M013
good sense childrens pain and fever	ACETAMINOPHEN	L. Perrigo Company	ab96395c-a19e-40d6-b37e-7f988026fc95	2024-05-06	Warnings	Exact identifier application number: M013
Good Sense pain and fever	ACETAMINOPHEN	L. Perrigo Company	48833e6a-db42-42b8-aa75-07103a1482a2	2024-04-30	Warnings	Exact identifier application number: M013
basic care infants pain and fever	ACETAMINOPHEN	Amazon.com Services LLC	aaa2b462-5ccf-43b0-9d71-71de74653a21	2024-04-29	Warnings	Exact identifier application number: M013
St. Joseph Low Dose Aspirin	ASPIRIN	Foundation Consumer Healthcare	dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f	2024-04-26	Warnings	Exact identifier application number: M013
Aspirin 50 CT	ASPIRIN	JHK Inc dba American Safety & First Aid	6009842a-c6ae-4582-a80f-364fc8a13a7a	2024-04-26	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