Pain Relief PM

Product NDC: 55910-655
11-digit product format: 559100655
Labeler code: 55910
Product ID: 55910-655_576227a6-39d3-4f42-b52f-261ad038c632
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Diphenhydramine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: DOLGENCORP, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-12-17
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

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 PM
Brand name suffix: Extra Strength
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
8e65478b-7a7b-416c-b8e3-23dad79f8cc1	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55910-655-10	Pain Relief PMExtra Strength	1 in 1 CARTON	TABLET, COATED	1	16
55910-655-10	Pain Relief PMExtra Strength	40 in 1 BOTTLE, PLASTIC	TABLET, COATED	40	16
55910-655-31	Pain Relief PMExtra Strength	80 in 1 BOTTLE, PLASTIC	TABLET, COATED	80	16
55910-655-31	Pain Relief PMExtra Strength	1 in 1 CARTON	TABLET, COATED	1	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [DOLGENCORP, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-655	PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, COATED [DOLGENCORP, LLC]	15	Current NDC, Legacy NDC, 4 package rows	20250416_8e65478b-7a7b-416c-b8e3-23dad79f8cc1.zip

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

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	8e65478b-7a7b-416c-b8e3-23dad79f8cc1	16
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	8e65478b-7a7b-416c-b8e3-23dad79f8cc1	16
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	8e65478b-7a7b-416c-b8e3-23dad79f8cc1	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-655-10	55910065510	1 BOTTLE, PLASTIC in 1 CARTON (55910-655-10) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC	2007-12-17	0000-00-00	No	No	Current
55910-655-31	55910065531	1 BOTTLE, PLASTIC in 1 CARTON (55910-655-31) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC	2007-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dollar General 44-556	DOLGENCORP, LLC \| LNK International, Inc.	2026-04-16	HUMAN OTC DRUG LABEL	16