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 41 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense pain relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3c1f505d-0319-a179-e063-6294a90a0b17	2025-08-11	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PROSTAT FIRST AID	3bdb9d89-9000-69f9-e063-6294a90a0c97	2025-08-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3bdbea6a-3f11-9142-e063-6294a90a20ea	2025-08-08	Warnings	Exact identifier application number: M013
Aspi-Cor	ASPIRIN	L.N.K. International, Inc.	9f919a48-ffd8-49fa-b6fd-ec71cc12e64b	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	8575ef9d-2eae-412a-a252-82b03f4d5275	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	7a91b1df-8d6d-4205-9822-bc4d800555f7	2025-08-08	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	3d6bf733-800c-420a-a9ab-ae4a26134799	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	44b8c203-37c5-425e-9110-f7eb614f9c2d	2025-08-08	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	c46688ec-e976-4f76-9265-645f59970ff5	2025-08-06	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	P & L Development, LLC	c54ad829-f2e8-4367-b439-af20b0ef8ad2	2025-08-06	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	398d8996-b522-a3cd-e063-6394a90ac2c8	2025-08-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Marlex Pharmaceuticals Inc.	cc7013ea-cf30-6f59-e053-2a95a90a1148	2025-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3ba313db-bafe-1947-e063-6294a90a528c	2025-08-05	Warnings	Exact identifier application number: M013
MEDIQUE APAP acetaminophen	MEDIQUE APAP ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	3ba5c802-fe5a-e42a-e063-6394a90ae67e	2025-08-05	Warnings	Exact identifier application number: M013
meijer EXTRA STRENGTH Pain Relief PM CAPLET	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	376fed3b-7625-6379-e063-6394a90a188d	2025-08-05	Warnings	Exact identifier application number: M013
CAREONE INFANTS ACETAMINOPHEN	ACETAMINOPHEN	Retail Business Services, LLC	b8024ec2-97c6-4aa1-b1dd-894164f48811	2025-08-04	Warnings	Exact identifier application number: M013
Exaprin Plus	ASPIRIN, ACETAMINOPHEN, CAFFEINE	HART Health	8a9ca680-e6cf-4ee4-8a5f-bd6d7470b848	2025-08-04	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Proficient Rx LP	2ef0757a-fe5f-47de-906a-a4d47a0d0534	2025-08-01	Warnings	Exact identifier application number: M013
Good Sense Pain Relief	ACETAMINOPHEN	Proficient Rx LP	b4cb4a62-9ef7-4185-8770-e9a806c2fb3f	2025-08-01	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad21a3-6229-e91b-e063-6394a90a7933	2025-07-29	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