Home NDC 68391-004 Berkley and Jensen Pain Relief
Product NDC 68391-004
11-digit product format 683910004
Labeler code 68391
Product ID 68391-004_c7b92375-0d31-4457-9517-8722eb8e2f7a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BJWC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-11-30
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Berkley and Jensen Pain Relief
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68391-004-79 Berkley and Jensen Pain Relief 400 in 1 BOTTLE TABLET, FILM COATED 400 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-004 BERLEY AND JENSEN PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [BJWC] 4 Current NDC, Legacy NDC, 1 package rows 20240418_d3ee3341-93b8-487c-921e-2892d213efbb.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 48 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin 81 mg ASPIRIN Asclemed USA, Inc. 878dab20-668b-4d7a-a5f8-794a587564d5 2025-02-13 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN CVS HEALTH CORP bbc48c9e-7eb8-2c67-e053-2a95a90a8552 2025-02-13 Warnings Exact identifier application number: M013 Dye Free Infants Pain and Fever ACETAMINOPHEN CVS 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 2025-02-13 Warnings Exact identifier application number: M013 NOTTS - Extra Strength 500 mg ACETAMINOPHEN VIVUNT PHARMA LLC e677f43d-b4ce-e5b0-e053-2a95a90ad67e 2025-02-12 Warnings Exact identifier application number: M013 Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN, ASPIRIN, CAFFEINE LEADER/ Cardinal Health 110, Inc. b3773f02-02a9-33c8-e053-2995a90a2235 2025-02-11 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC. c9f80d24-bd05-e1ce-e053-2995a90aa646 2025-02-10 Warnings Exact identifier application number: M013 Low dose Aspirin ASPIRIN 81 MG DELAYED RELEASE TABLETS WALGREENS c25c55aa-9932-0a55-e053-2a95a90a3d1e 2025-02-10 Warnings Exact identifier application number: M013 AeroTab Pain Reliever PAIN RELIEVER Aero Healthcare 40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f 2025-02-10 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Time-Cap Labs, Inc 5fbd8bb3-46f9-4089-9a21-b6af97a06106 2025-02-08 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABS INC c193dbc0-cc80-4a7c-aa29-457a20edf835 2025-02-08 Warnings Exact identifier application number: M013 Daytime Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HBR Genexa Inc. 22f23aeb-f874-6e54-e063-6394a90a9565 2025-02-07 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN BETTER LIVING BRANDS LLC. f3008928-c555-64ad-e053-2995a90a7307 2025-02-05 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN BETTER LIVING BRANDS LLC. f300dfbc-7137-79d1-e053-2995a90a636e 2025-02-05 Warnings Exact identifier application number: M013 Low dose aspirin 81mg ASPIRIN BETTER LIVING BRANDS LLC. f300c30b-ab1a-a1b4-e053-2a95a90a1294 2025-02-05 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 5d174187-cf89-41ff-9a64-10e0276daf17 2025-02-05 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN Bryant Ranch Prepack c226205d-7c3c-49af-b3e2-fc7b09ad7857 2025-02-05 Warnings Exact identifier application number: M013 Dye Free Childrens Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma a69fca9d-c0a0-4321-bf03-5c8e99cc07cc 2025-02-04 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN-CAFFEINE TARGET CORPORATION 8ed1679d-d3a1-11b1-e053-2995a90a61ad 2025-01-31 Warnings Exact identifier application number: M013 ValuMeds Extra Strength Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Cabinet Health P.B.C. 0f864e73-e4b8-4e23-8990-8439ac17bd58 2025-01-31 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN TABLETS 500 MG WALGREENS c25bfe92-0196-0489-e053-2995a90abea1 2025-01-30 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68391-004-79 68391000479 400 TABLET, FILM COATED in 1 BOTTLE (68391-004-79) 2015-11-30 0000-00-00 No No Current