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 4 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gencare-Aspirin Low Dose Pain reliever (NSAID) ASPIRIN Pioneer Life Sciences, LLC 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc 2026-08-09 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN DOLGENCORP, LLC b4064039-2345-4227-b83d-54dc13a838d3 2026-08-07 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN United Natural Foods, Inc. dba UNFI 87def9e0-0246-42cf-b8ea-2513d52e9f68 2026-08-07 Warnings Exact identifier application number: M013 berkley and jensen acetaminophen ACETAMINOPHEN BJWC dee57d73-73ac-48bb-b1da-9971f1ff21c4 2026-08-07 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Salado Sales, Inc. aef30709-f33d-48ff-b2d4-0639ffbd1ffd 2026-08-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN P & L Development, LLC 4cd74cec-a209-4e92-b853-fbe5c95f7678 2026-08-06 Warnings Exact identifier application number: M013 Tension Headache Aspirin-Free ACETAMINOPHEN, CAFFEINE Rite Aid Corporation 093a7c26-f2b1-4416-b193-81133d247d2e 2026-08-06 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bc17b2e5-4828-6a2e-e053-2995a90a8c63 2026-08-05 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 997b9551-c222-4a9c-8ba1-09a5f97495fa 2026-08-05 Warnings Exact identifier application number: M013 Mantra Pain Gel raspberry ACETAMINOPHEN MOREMED INC. 7c8bdf49-a6d2-4e42-b006-375f103fd0ac 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER d2d2846d-4e0b-4d42-b300-60dd3b2cca1b 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER 960f5676-d8c5-470b-a663-4b8d152339b4 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER a60f6439-2033-4bd2-b78c-6c083414a12b 2026-08-05 Warnings Exact identifier application number: M013 pain relief PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE HARRIS TEETER 0afb6181-d0b1-4845-8230-faabf1b997dc 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Harris Teeter 8a3e3439-90ae-4fc9-8ff2-44b8363fa338 2026-08-05 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Harris Teeter 50e7b939-e0eb-44ea-82ea-034e844e2c29 2026-08-05 Warnings Exact identifier application number: M013 pain relief aspirin Low Dose ASPIRIN Rite Aid Corporation df7835c9-f10f-40c6-8955-61423d94b677 2026-08-05 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN DOLGENCORP, LLC 7396c97e-8a51-4a21-8208-f13258b5285c 2026-08-05 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN Rite Aid Corporation 3b5d4a5a-8c65-4db1-bf01-e8df6523f45a 2026-08-04 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN WinCo Foods, LLC 4749a843-9c93-4edd-9b5f-a1e32666544e 2026-08-04 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