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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANADOL Extra	ACETAMINOPHEN AND CAFFEINE	Haleon US Holdings LLC	e5c2d88a-d903-4ca0-b895-f27e791dfc4e	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	9d384e88-5c11-4600-ac6c-a38371570138	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	95801755-db54-4ad7-bec1-52671914f6ca	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	01e7dddb-755c-4745-b701-edcdb6209064	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	fe7cd1f2-9b00-4ded-99c2-8a152c71093c	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	9064943f-836f-4853-b6f2-2c4879941eeb	2024-02-02	Warnings	Exact identifier application number: M013
Quality Choice Effervescent Pain Relief	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	079af5d7-1be8-2a93-e063-6294a90a496d	2024-02-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin	ACETAMINOPHEN	Proficient Rx LP	4c84948d-3a95-4c53-8529-7e7b9d8bb6df	2024-02-01	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	9c7d65e4-df2f-47c1-a185-66aaf19aad2b	2024-02-01	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	57e4820c-b4eb-442e-9c49-93eedfbc5e5e	2024-02-01	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	Proficient Rx LP	73013074-9c6e-43c7-acde-4d9d8ed0133d	2024-02-01	Warnings	Exact identifier application number: M013
MEDIQUE APAP Extra Strength	ACETAMINOPHEN	Proficient Rx LP	c466a07f-2339-4cf5-8377-e0f109649c52	2024-02-01	Warnings	Exact identifier application number: M013
Percogesic Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE	Medtech Products Inc.	2c5f1140-fb83-42c9-b0b1-5e2bd69340bb	2024-02-01	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Proficient Rx LP	3c7783a7-2b28-4968-b766-0a49dc70ce6d	2024-02-01	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	102bdcde-cb90-f248-e063-6394a90aac79	2024-01-30	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Haleon US Holdings LLC	61802b27-c9ec-4386-9d44-45e8b1e558b7	2024-01-28	Warnings	Exact identifier application number: M013
AGRIFEN	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	0fde22da-cdfc-36cc-e063-6294a90a3885	2024-01-26	Warnings	Exact identifier application number: M013
DOLODOL	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e80536f1-92cc-5bb3-e053-2995a90a9540	2024-01-26	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	d913d11f-c7a1-49d2-a2d3-9a29fc032806	2024-01-18	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