Home NDC 67751-167-04 Tylenol Extra Strength
Product NDC 67751-167
Requested package NDC 67751-167-04
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 date Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…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 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67751-167-04 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