Pain Relief PM

Product NDC: 69168-267
11-digit product format: 691680267
Labeler code: 69168
Product ID: 69168-267_66e9c2e8-6406-4818-925a-214810f6b126
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen 500 mg and Diphenhydramine HCl 25 mg
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-12-23
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69168-267		I	Inactivated by FDA	2026-10-20
excluded package	package	69168-267	69168-267-02	I	Inactivated by FDA	2026-10-20
excluded package	package	69168-267	69168-267-24	I	Inactivated by FDA	2026-10-20
excluded package	package	69168-267	69168-267-50	I	Inactivated by FDA	2026-10-20
excluded package	package	69168-267	69168-267-99	I	Inactivated by FDA	2026-10-20

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 · 105 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	69168-267-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69168-267-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69168-267-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69168-267-99	`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	69168-267-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69168-267-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69168-267-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69168-267-99	`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	69168-267-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69168-267-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69168-267-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69168-267-99	`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	69168-267-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69168-267-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69168-267-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69168-267-99	`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	69168-267-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69168-267-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69168-267-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69168-267-99	`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	69168-267-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69168-267-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69168-267-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69168-267-99	`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	69168-267-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69168-267-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69168-267-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69168-267-99	`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	69168-267-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69168-267-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69168-267-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69168-267-99	`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	69168-267-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69168-267-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69168-267-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69168-267-99	`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	69168-267-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69168-267-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69168-267-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69168-267-99	`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	69168-267-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69168-267-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69168-267-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69168-267-99	`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	69168-267-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69168-267-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69168-267-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69168-267-99	`557ba5c1ecfa…`	`9c80585c8c6e…`

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, Related label table
NDC	Related label
69168-267-02	Drug Facts
69168-267-24	Drug Facts
69168-267-50	Drug Facts
69168-267-99	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-267-02	Pain Relief PMExtra Strength	150 in 1 BOTTLE	TABLET	150	4
69168-267-24	Pain Relief PMExtra Strength	24 in 1 CARTON	TABLET	24	4
69168-267-50	Pain Relief PMExtra Strength	50 in 1 CARTON	TABLET	50	4
69168-267-99	Pain Relief PMExtra Strength	365 in 1 BOTTLE	TABLET	365	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-267	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG) TABLET [ALLEGIANT HEALTH]	4	Legacy NDC, 4 package rows	20181222_91ba1618-1b2e-4281-a5e1-ba7acbae8346.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	91ba1618-1b2e-4281-a5e1-ba7acbae8346	4
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	91ba1618-1b2e-4281-a5e1-ba7acbae8346	4
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	91ba1618-1b2e-4281-a5e1-ba7acbae8346	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69168-267-02	69168026702	150 in 1 BOTTLE	Historical
69168-267-24	69168026724	24 in 1 CARTON	Historical
69168-267-50	69168026750	50 in 1 CARTON	Historical
69168-267-99	69168026799	365 in 1 BOTTLE	Historical