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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bb31f66c-80a9-4bdb-983b-cef5d21de5ff	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-013-71	2020-01-31	C162847	48780-1	9d75b9d0-b84e-f424-e053-dadaa90a57ce	Duralgina

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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mapap	ACETAMINOPHEN	Major Pharmaceuticals	efec6af2-8b26-47f6-88c8-b0a6d69a2d7d	2026-06-03	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	ae3114c3-8cfe-4b81-8ac7-c281fe68b462	2026-06-03	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	COSTCO WHOLESALE CORPORATION	3745aa18-a711-43ed-9bc4-1f087b3c53c0	2026-06-03	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3f653262-b931-7d42-e063-6394a90adddd	2026-06-03	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walgreen Company	0b1bef50-7957-4ea1-9ae3-91f59ea2dbb4	2026-06-03	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	42310898-cf3a-4ffb-88bb-b8b84449156e	2026-06-02	Warnings	Exact identifier application number: M013
PAIN RELIEF	ACETAMINOPHEN	Meijer, Inc.	1319bab8-8f17-44fb-9d91-099b0ba38a8d	2026-06-01	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Family Dollar (FAMILY WELLNESS)	7a98d4d9-54e2-45c1-a76a-7f1907566e95	2026-06-01	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	58840cf4-aceb-c7cf-e063-6294a90a5ff4	2026-06-01	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS Pharmacy	832acd72-1dda-4490-978f-5f31748942df	2026-06-01	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	786dbcd5-f5c2-4491-e053-2991aa0a3437	2026-05-29	Warnings	Exact identifier application number: M013
Back and Body Extra Strength	ASPIRIN, CAFFEINE	Meijer Distribution Inc	e513f2d9-d591-4790-a117-6176ce2279dc	2026-05-29	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	5460a4b7-5da3-4fc2-a565-0b0dd11bbf44	2026-05-29	Warnings	Exact identifier application number: M013
Extra Strength Mini Softgels Pain Reliever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f55d3663-7007-41cd-ae2d-5aca6311be81	2026-05-28	Warnings	Exact identifier application number: M013
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	5130c695-a80e-2dd3-e063-6294a90a404f	2026-05-28	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	1622f694-4d63-4c56-8737-fae31f0ecfb7	2026-05-27	Warnings	Exact identifier application number: M013
INFANTS Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	257436e1-e0f3-4a87-bffe-4f176b836caf	2026-05-27	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	6509a545-0036-460a-8f0d-b31caae17855	2026-05-27	Warnings	Exact identifier application number: M013
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Select Consumer Group	3ca80d74-1e8b-49d9-e063-6394a90a4312	2026-05-24	Warnings	Exact identifier application number: M013
Pain and Fever Chewables Childrens	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	bad8ac0a-518d-4639-9b92-a39e0d437238	2026-05-22	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313782	acetaminophen 325 MG Oral Tablet	PSN	bb31f66c-80a9-4bdb-983b-cef5d21de5ff	11
313782	acetaminophen 325 MG Oral Tablet	SCD	bb31f66c-80a9-4bdb-983b-cef5d21de5ff	11
313782	APAP 325 MG Oral Tablet	SY	bb31f66c-80a9-4bdb-983b-cef5d21de5ff	11

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