FDA.reportPublic FDA data

Tylenol Extra Strength

Product NDC
67751-167
Requested package NDC
67751-167-01
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

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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 9 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINARMY AND AIR FORCE EXCHANGE SERVICEe273ead7-7cbc-4fd5-a136-9d3558a353602026-06-24WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
application number: M013
Pain Relief Aspirin Chewable, Low DoseASPIRINRite Aid Corporation65cdce0f-be04-43ba-8c68-bdce7983cfa12026-06-22WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leader88f425df-712d-4911-824b-94085c7190b62026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMeijer Distribution, Inc.3716a7d4-a555-4e54-aa0a-7b8f3e32addb2026-06-19WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.2f6ec676-3832-420e-be91-fce83f6586c82026-06-19WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINFamora Inc.4dc6f119-bbde-db5f-e063-6294a90a94862026-06-16WarningsExact identifier
application number: M013
Childrens Pain and Fever ReliefACETAMINOPHENChain Drug Marketing Association, Inc.420a1e05-caa6-481f-bdab-a670f0220f962026-06-16WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDOLGENCORP, LLCce9f4e0d-43fb-499a-b8a2-a997a14841c42026-06-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENL.N.K. International, Inc.734cc3d2-6fc5-4dcc-93ed-0b57c1f013452026-06-15WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d63671d-cf7c-bbdd-e063-6294a90affef2026-06-15WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENShield Pharmaceuticals Corp.96eb7f9f-ff2d-4661-bbe6-1860aafe03f62026-06-15WarningsExact identifier
application number: M013
Duralgina Extra StrengthACETAMINOPHENMenper Distributors, Inc.544e3d7e-a759-384f-e063-6294a90a5baa2026-06-15WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporationbe2286a1-946b-4bf5-b14c-8e86da6695942026-06-15WarningsExact identifier
application number: M013
Aspirin 81ASPIRINAmerisource Bergen4491faca-f30b-4eb0-bea9-f518f6b2f0952026-06-15WarningsExact 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