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		2026-10-05
excluded package	package	67751-167	67751-167-03	D	Discontinued by firm		2026-10-05

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 43 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	4005f8dd-3050-4590-8703-6997444e8df3	2025-08-13	Warnings	Exact identifier application number: M013
good sense headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	4cae0580-7ee3-4f38-8d13-79c7d7615f8f	2025-08-12	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Exact identifier application number: M013
Dr Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Farmacias De Similares TX LLC	3c19ad99-6e0f-3116-e063-6394a90a914c	2025-08-11	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3c1f505d-0319-a179-e063-6294a90a0b17	2025-08-11	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PROSTAT FIRST AID	3bdb9d89-9000-69f9-e063-6294a90a0c97	2025-08-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3bdbea6a-3f11-9142-e063-6294a90a20ea	2025-08-08	Warnings	Exact identifier application number: M013
Aspi-Cor	ASPIRIN	L.N.K. International, Inc.	9f919a48-ffd8-49fa-b6fd-ec71cc12e64b	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	8575ef9d-2eae-412a-a252-82b03f4d5275	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	7a91b1df-8d6d-4205-9822-bc4d800555f7	2025-08-08	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	3d6bf733-800c-420a-a9ab-ae4a26134799	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	44b8c203-37c5-425e-9110-f7eb614f9c2d	2025-08-08	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	c46688ec-e976-4f76-9265-645f59970ff5	2025-08-06	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	P & L Development, LLC	c54ad829-f2e8-4367-b439-af20b0ef8ad2	2025-08-06	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	398d8996-b522-a3cd-e063-6394a90ac2c8	2025-08-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Marlex Pharmaceuticals Inc.	cc7013ea-cf30-6f59-e053-2a95a90a1148	2025-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3ba313db-bafe-1947-e063-6294a90a528c	2025-08-05	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