Home NDC 67751-167 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
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.
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 28 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN PUBLIX SUPERMARKETS, INC 08f57305-0c4b-96b1-e063-6394a90a77df 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine HCL ACETAMINOPHEN AND DIPHENHYDRAMINE HCL PUBLIX SUPERMARKETS, INC 08f549cf-042a-7bf2-e063-6394a90a83ef 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b8a855ae-c0a3-0b05-e053-2a95a90ac8a8 2025-12-19 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Marc Glassman, Inc. f708e1ec-cf2a-4e2b-851f-f6b703f359b2 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREEN CO. b375de90-25c7-aa55-e053-2995a90a3cf8 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN TARGET CORPORATION e64a3c32-5466-0662-e053-2a95a90ae963 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCL ACETAMINOPHEN DIPHENHYDRAMINE HCL WALGREENS CO. d92d97a8-0ee3-1206-e053-2a95a90a72a8 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN SAM'S WEST INC 0c8e7095-0806-4501-e063-6394a90a89aa 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCL ACETAMINOPHEN DIPHENHYDRAMINE HCL WALGREEN CO. b3763182-2428-155a-e053-2995a90ab578 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN WALGREENS e467b78e-9f23-5563-e053-2a95a90a586e 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen Diphenhydramine HCL ACETAMINOPHEN DIPHENHYDRAMINE HCL Walgreens fd7c3250-35d4-494a-e053-6394a90a2db5 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC 1ddb8a2b-3081-3eda-e063-6294a90ab82b 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC b1307d52-10e6-46e1-e053-2995a90a03b6 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC c2c6d6a1-b492-506d-e053-2995a90aac23 2025-12-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN FAMILY DOLLAR f8383108-0970-9f1e-e053-6294a90ad38f 2025-12-19 Warnings Exact identifier application number: M013 ACETAMINOPHEN 500 MG ACETAMINOPHEN NUVICARE LLC 591ee107-e953-4982-b75f-13a0afd7c4ae 2025-12-19 Warnings Exact identifier application number: M013 Nuvicare Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE NUVICARE LLC 3ede0fb6-c089-4253-9878-2b01c39e9c87 2025-12-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN NUVICARE LLC 3a4aa3c7-b726-4303-8803-74196fa5637a 2025-12-19 Warnings Exact identifier application number: M013 ACETAMINOPHEN 500 MG ACETAMINOPHEN NUVICARE LLC 95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e 2025-12-19 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE NUVICARE LLC 32a5611b-9bf6-4850-a7ff-fa240da04f45 2025-12-19 Warnings Exact identifier application number: M013
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 67751-167-01 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