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 57 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join aspirin ASPIRIN A-S Medication Solutions 65c41c20-2f9c-4012-900b-c2ffdf665144 2024-11-06 Warnings Exact identifier application number: M013 foster and thrive pain reliever ACETAMINOPHEN Strategic Sourcing Services LLC 338021bd-b92b-45eb-a4b8-bc4a100ab718 2024-11-06 Warnings Exact identifier application number: M013 basic care headache relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Amazon.com Services LLC f85d2f4c-8184-4555-a310-3979722e860b 2024-11-05 Warnings Exact identifier application number: M013 MENSTRUAL COMPLETE MENSTRUAL COMPLETE Allegiant Health d197b886-67e4-4aba-8582-305576c07604 2024-11-05 Warnings Exact identifier application number: M013 dg health headache relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp Inc ddf40cc4-d73f-4460-be72-9486134329a7 2024-11-05 Warnings Exact identifier application number: M013 DOLO- NeuroBion Acetaminophen 500mg ACETAMINOPHEN BENARD INDUSTRIES INC 16f8415d-8190-4212-b487-c0caf7d3bee2 2024-11-04 Warnings Exact identifier application number: M013 basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC 8c3343ee-d7b6-496d-9702-6736539a7270 2024-11-02 Warnings Exact identifier application number: M013 dg health pain relief ACETAMINOPHEN Dolgencorp, LLC 382fa2cc-1c39-4bee-b528-08b11ec945af 2024-11-02 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN Bryant Ranch Prepack f7e20527-1d4b-434c-997b-3eb8211fdaa1 2024-11-01 Warnings Exact identifier application number: M013 Aspirin Enteric Safety Coated ASPIRIN Publix Supermarkets, Inc. a661a9ed-9b31-46b1-aafb-61d1ba8a4918 2024-11-01 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 614e69c7-d3cb-4d47-9603-c1c14b87544c 2024-11-01 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation baee03b8-fcfd-440e-90ea-1ee2a18516ef 2024-11-01 Warnings Exact identifier application number: M013 good neighbor pharmacy infants pain and fever ACETAMINOPHEN Amerisource Bergen bfb954b7-3a79-4bca-95e8-d39e1074b07f 2024-11-01 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE Proficient Rx LP bf365bfc-35cc-47f9-a50b-ff2b38d7316b 2024-11-01 Warnings Exact identifier application number: M013 Infants Pain Relief ACETAMINOPHEN Publix Super Markets Inc 0bc33897-afc2-4d11-be6c-a26480f448bf 2024-10-31 Warnings Exact identifier application number: M013 equate infants pain and fever ACETAMINOPHEN WALMART INC. 34b2512e-743b-45db-92cb-ea05e2f47b3d 2024-10-31 Warnings Exact identifier application number: M013 foster and thrive infants pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC 45770ad6-9bf7-41bd-a724-e5260cd31fa1 2024-10-31 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET Lil' Drug Store Products, Inc. d20425a4-f074-4154-e053-2995a90ae9fd 2024-10-30 Warnings Exact identifier application number: M013 up and up infants acetaminophen ACETAMINOPHEN Target Corporation 31104956-04d7-41b5-82be-219ded5c02a9 2024-10-30 Warnings Exact identifier application number: M013 Sunmark Aspirin ASPIRIN Strategic Sourcing Services LLC a7139686-b351-47dc-a395-832429aaa569 2024-10-30 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