FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67751-16767751-167-04DDiscontinued by firm2026-10-05
excluded packagepackage67751-16767751-167-03DDiscontinued by firm2026-10-05

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-167-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-167-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-167-041332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67751-167-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67751-167-01fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67751-167-04fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67751-167-03fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67751-167-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67751-167-0186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67751-167-0486f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67751-167-0386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67751-167-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67751-167-01bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67751-167-04bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67751-167-03bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67751-167-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67751-167-038dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67751-167-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67751-167-039bebd1f3094a…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
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86b6ac01-3866-4cd8-a1be-9babb6ff311bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
67751-167-012024-04-17d6a99b39-4b62-a426-e053-dadaa90af4c2Tylenol Extra Strength
67751-167-022024-04-17d6a99b39-4b62-a426-e053-dadaa90af4c2Tylenol Extra Strength
67751-167-032024-04-179d75b9cf-e68d-f424-e053-dadaa90a57ceTylenol Extra Strength
67751-167-042024-04-17d6a99b39-4b62-a426-e053-dadaa90af4c2Tylenol Extra Strength
67751-167-012022-01-28d6a99b39-4b62-a426-e053-dadaa90af4c2Tylenol Extra Strength
67751-167-022022-01-28d6a99b39-4b62-a426-e053-dadaa90af4c2Tylenol Extra Strength
67751-167-042022-01-28d6a99b39-4b62-a426-e053-dadaa90af4c2Tylenol Extra Strength
67751-167-032020-01-319d75b9cf-e68d-f424-e053-dadaa90a57ceTylenol Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-167-01Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED16
67751-167-01Tylenol Extra Strength2 in 1 POUCHTABLET, FILM COATED26
67751-167-02Tylenol Extra Strength4 in 1 POUCHTABLET, FILM COATED46
67751-167-02Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED16
67751-167-04Tylenol Extra Strength12 in 1 TRAYTABLET, FILM COATED126
67751-167-04Tylenol Extra Strength1 in 1 POUCHTABLET, FILM COATED16
67751-167-03Tylenol Extra Strength12 in 1 TRAYTABLET, FILM COATED122
67751-167-03Tylenol Extra Strength2 in 1 POUCHTABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-167TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]6Current NDC, Legacy NDC, 6 package rows20241004_86b6ac01-3866-4cd8-a1be-9babb6ff311b.zip
67751-167TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, Legacy NDC, 2 package rows20240418_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 50 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INC8f221fdb-8138-c1a8-e053-2995a90a29c22025-01-11WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions3294ba24-f198-485e-88fc-435964434b802025-01-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals32ea1230-f9ae-46b0-910e-05cd187cee342025-01-09WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLCe817bc4a-43ef-4126-b903-aabd1390cd0c2025-01-08WarningsExact identifier
application number: M013
GeriCare Liquid Pain ReliefACETAMINOPHENGeri-Care Pharmaceuticals, Corp85a074da-14b7-4db5-9d47-8ad19f5207212025-01-06WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINMeijer Distribution Inceb29d6be-f095-44b2-b6ed-7e4167b596f82025-01-02WarningsExact identifier
application number: M013
Headache, Circle KACETAMINOPHEN, CAFFEINE, ASPIRIN TABLETLil' Drug Store Products, Inc.e711ff0a-2fa0-1f2a-e053-2a95a90a4e382024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Lil Drug StoreEXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0c41deda-490b-f5d2-e063-6394a90a50472024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache, Circle KACETAMINOPHEN/ASPIRIN/CAFFEINE TABLETLil' Drug Store Products, Inc.d18e1631-de43-4b29-e053-2995a90af56d2024-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN 500 MG, FILM-COATED TABLETLil' Drug Store Products, Inc.e5f9def4-4cf5-4e06-e053-2995a90a07ea2024-12-31WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp6158e954-32d8-4718-e053-2a91aa0a27f32024-12-31WarningsExact identifier
application number: M013
AspirinASPIRINAdvanced Rx Pharmacy of Tennessee, LLCf8375029-e567-c6a5-e053-6394a90a5b672024-12-31WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEDollar General4907056d-6013-46b1-ae86-469dc30015912024-12-31WarningsExact identifier
application number: M013
Pediacare Childrens GrapeACETAMINOPHENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTHf9d531a2-234c-4feb-8f05-212dbee83dfe2024-12-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459Tylenol Extra Strength 500 MG Oral TabletPSN86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD86b6ac01-3866-4cd8-a1be-9babb6ff311b6
198440acetaminophen 500 MG Oral TabletSCD86b6ac01-3866-4cd8-a1be-9babb6ff311b6
198440APAP 500 MG Oral TabletSY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459APAP 500 MG Oral Tablet [Tylenol]SY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459Tylenol 500 MG Oral TabletSY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459Tylenol Extra Strength 500 MG Oral TabletSY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
198440acetaminophen 500 MG Oral TabletPSN65bf1556-f25a-9439-e053-2a91aa0a31942
209459Tylenol Extra Strength 500 MG Oral TabletPSN65bf1556-f25a-9439-e053-2a91aa0a31942
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD65bf1556-f25a-9439-e053-2a91aa0a31942
198440acetaminophen 500 MG Oral TabletSCD65bf1556-f25a-9439-e053-2a91aa0a31942
198440APAP 500 MG Oral TabletSY65bf1556-f25a-9439-e053-2a91aa0a31942
209459APAP 500 MG Oral Tablet [Tylenol]SY65bf1556-f25a-9439-e053-2a91aa0a31942
209459Tylenol 500 MG Oral TabletSY65bf1556-f25a-9439-e053-2a91aa0a31942
209459Tylenol Extra Strength 500 MG Oral TabletSY65bf1556-f25a-9439-e053-2a91aa0a31942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-167-01677510167011 POUCH in 1 CARTON (67751-167-01) / 2 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent
67751-167-02677510167021 POUCH in 1 CARTON (67751-167-02) / 4 TABLET, FILM COATED in 1 POUCH1 pouch2016-09-220000-00-00NoNoCurrent
67751-167-036775101670312 in 1 TRAYHistorical
67751-167-046775101670412 POUCH in 1 TRAY (67751-167-04) > 1 TABLET, FILM COATED in 1 POUCH12 pouch2016-09-220000-00-00NoNoCurrent