Pain Relief

Product NDC: 42507-437
11-digit product format: 425070437
Labeler code: 42507
Product ID: 42507-437_e51575cc-8d80-47d9-93b7-96c19ce5f4d3
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: HyVee Inc
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-11-19
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500; 25 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42507-437	42507-437-78	D	Discontinued by firm		2026-10-16

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 · 36 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	42507-437-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-437-78	`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	42507-437-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-437-78	`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	42507-437-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-437-78	`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	42507-437-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-437-78	`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	42507-437-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-437-78	`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	42507-437-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-437-78	`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	42507-437-71	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42507-437-78	`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	42507-437-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42507-437-78	`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	42507-437-71	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42507-437-78	`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	42507-437-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-437-78	`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	42507-437-71	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-437-78	`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	42507-437-71	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-437-78	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Pain Relief
Brand name suffix: PM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1092189	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
4f45a750-1220-4a81-801e-bf08c9d117d6	Available on FDA.report

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [HYVEE INC]	2

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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chewable Aspirin	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d68ea-7f25-881f-e053-2995a90aa47f	2024-10-15	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d750e-5a85-77f5-e053-2995a90a6915	2024-10-15	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Walgreen Company	9e08eb38-7538-4fa0-a0e1-047ab6cb1680	2024-10-15	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	PUBLIX SUPER MARKETS INC	9e779cc6-4641-6132-e053-2a95a90a3493	2024-10-11	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	CHAIN DRUG CONSORTIUM	5c1a3081-ae25-4895-bf76-ebcbb9fc8072	2024-10-11	Warnings	Exact identifier application number: M013
Aspirin 81 MG	ASPIRIN	Meijer	b3e5711c-9529-4eec-871d-de8efa858b86	2024-10-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	9586e830-a285-4a07-8b34-969875442348	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	5de40821-3218-4320-bf11-9493bf01d489	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	475becec-1a56-4cfa-a0c5-562f8772adfb	2024-10-11	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Topco Associates LLC	6036c15b-1168-4103-9471-6a74a2140e53	2024-10-10	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	46d9d8cd-e3db-492c-9386-7e8255beff64	2024-10-08	Warnings	Exact identifier application number: M013
dg health aspirin	ASPIRIN	Dolgencorp, LLC	0ab34dc7-0110-4fc3-ae53-234e7d7bca3c	2024-10-07	Warnings	Exact identifier application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	19ba1fb6-22ea-488e-9e52-94c14ceb80d1	2024-10-07	Warnings	Exact identifier application number: M013
foster and thrive aspirin	ASPIRIN	Strategic Sourcing Services LLC	4d66a8a8-a1c1-4430-8845-21ae67700c39	2024-10-07	Warnings	Exact identifier application number: M013
leader aspirin	ASPIRIN	Cardinal Health 110, LLC. dba Leader	ca603b12-e0f7-4d79-8e0d-4651a788ba9b	2024-10-07	Warnings	Exact identifier application number: M013
foster and thrive aspirin	ASPIRIN	McKesson Medical-Surgical, Inc.	e9342478-93d6-45de-948f-f4162ee675b2	2024-10-07	Warnings	Exact identifier application number: M013
Maximum Strength Backache Relief	MAGNESIUM SALICYLATE	JHK DBA American Safety & First Aid	f8cbcd4e-cfad-4592-8774-52e681494c45	2024-10-07	Warnings	Exact identifier application number: M013
Alka-Seltzer Original Flavor	ALKA-SELTZER ORIGINAL FLAVOR	Navajo Manufacturing Company Inc.	f70875ab-241c-4876-e053-6294a90a8092	2024-10-03	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Navajo Manufacturing Company Inc.	86b6ac01-3866-4cd8-a1be-9babb6ff311b	2024-10-02	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
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-437-71	42507043771	1 BOTTLE in 1 CARTON (42507-437-71) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	1992-11-19	No	No	Current