Home NDC 53145-013 Duralgina
Product NDC 53145-013
11-digit product format 531450013
Labeler code 53145
Product ID 53145-013_3a893b13-e7ee-c5b1-e063-6394a90a4253
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Menper Distributors Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-01-01
Substance ACETAMINOPHEN
Active strength 325 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53145-013-71 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53145-013-71 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53145-013-71 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53145-013-71 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53145-013-71 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53145-013-71 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-013-71 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-013-71 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-013-71 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Duralgina
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 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 313782 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 53145-013-71 Duralgina 30 in 1 BOTTLE TABLET 30 11
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 Units Marketing start Sample Exclude flag Status 53145-013-71 53145001371 30 TABLET in 1 BOTTLE (53145-013-71) 30 tablet 2017-01-01 No No Current