Extra Strength Pain Relief PM

Product NDC: 53943-024
11-digit product format: 539430024
Labeler code: 53943
Product ID: 53943-024_e85c204f-2be9-4650-95d6-65ba5e89f915
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen 500mg Diphenhydramine HCl 25mg
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Discount Drug Mart
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-06-20
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53943-024		I	Inactivated by FDA	2026-10-05
excluded package	package	53943-024	53943-024-01	I	Inactivated by FDA	2026-10-05
excluded package	package	53943-024	53943-024-03	I	Inactivated by FDA	2026-10-05
excluded package	package	53943-024	53943-024-50	I	Inactivated by FDA	2026-10-05

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 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53943-024-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53943-024-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53943-024-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53943-024-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53943-024-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53943-024-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53943-024-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53943-024-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53943-024-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53943-024-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53943-024-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53943-024-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53943-024-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53943-024-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53943-024-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53943-024-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53943-024-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53943-024-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53943-024-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53943-024-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53943-024-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53943-024-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53943-024-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53943-024-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53943-024-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53943-024-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53943-024-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53943-024-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53943-024-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53943-024-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53943-024-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53943-024-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53943-024-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53943-024-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53943-024-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53943-024-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53943-024-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53943-024-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53943-024-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53943-024-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53943-024-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53943-024-50	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53943-024-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53943-024-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53943-024-50	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-024-01	2020-01-31	C162847	48780-1	9d75b9d1-1a19-f424-e053-dadaa90a57ce	e85c204f-2be9-4650-95d6-65ba5e89f915
53943-024-03	2020-01-31	C162847	48780-1	9d75b9d1-1a19-f424-e053-dadaa90a57ce	e85c204f-2be9-4650-95d6-65ba5e89f915
53943-024-50	2020-01-31	C162847	48780-1	9d75b9d1-1a19-f424-e053-dadaa90a57ce	e85c204f-2be9-4650-95d6-65ba5e89f915

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53943-024-01	Extra Strength Pain Relief PM	1 in 1 CARTON	TABLET, COATED	1	1
53943-024-01	Extra Strength Pain Relief PM	100 in 1 BOTTLE	TABLET, COATED	100	1
53943-024-03	Extra Strength Pain Relief PM	300 in 1 BOTTLE	TABLET, COATED	300	1
53943-024-50	Extra Strength Pain Relief PM	1 in 1 CARTON	TABLET, COATED	1	1
53943-024-50	Extra Strength Pain Relief PM	50 in 1 BOTTLE	TABLET, COATED	50	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-024	EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN 500MG DIPHENHYDRAMINE HCL 25MG) TABLET, COATED [DISCOUNT DRUG MART]	1	Legacy NDC, 5 package rows	20130620_e85c204f-2be9-4650-95d6-65ba5e89f915.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	e85c204f-2be9-4650-95d6-65ba5e89f915	1
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	e85c204f-2be9-4650-95d6-65ba5e89f915	1
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	e85c204f-2be9-4650-95d6-65ba5e89f915	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53943-024-01	53943002401	1 in 1 CARTON	Historical
53943-024-03	53943002403	300 in 1 BOTTLE	Historical
53943-024-50	53943002450	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Extra Strength Pain Relief PM - Discount Drug Mart	Discount Drug Mart	2013-06-18	Human OTC Drug Label	1