Pain Relief PM

Product NDC: 55910-655
Requested package NDC: 55910-655-31
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 49 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	38b839b6-de7d-4f33-a19a-efc92cdad92c	2025-01-24	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	523b68da-cd2a-4960-95e7-de5d51ce33c1	2025-01-23	Warnings	Exact identifier application number: M013
Safety Coated Aspirin 81 mg Low Dose	ASPIRIN 81MG	Ulai Health LLC	3d225a11-a53b-4dc2-9c25-13cab007900f	2025-01-20	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 325 MG	Ulai Health LLC	55bb7e6c-e98c-48bd-b7bb-9848ff0273ca	2025-01-20	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MG	Ulai Health LLC	d4a568c9-a721-48d1-aebc-fc65444947ce	2025-01-20	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	c9d3cee1-531c-439f-ae19-07acd366aad6	2025-01-20	Warnings	Exact identifier application number: M013
Percogesic Original Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Medtech Products Inc.	529974c2-0121-4892-8e47-c2c447581091	2025-01-17	Warnings	Exact identifier application number: M013
Little Remedies Childrens Fever Pain Reliever	ACETAMINOPHEN	Medtech Products Inc.	e1e44c85-d10c-4997-8f85-064cda7906eb	2025-01-17	Warnings	Exact identifier application number: M013
Stanback	ASPIRIN AND CAFFEINE	Medtech Products Inc.	caaa1313-09e4-45aa-8836-346f6a370196	2025-01-17	Warnings	Exact identifier application number: M013
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	Precision Dose Inc.	5cc698fa-0841-4851-ae21-0aac8b40eb0a	2025-01-16	Warnings	Exact identifier application number: M013
Ecotrin	ASPIRIN	Medtech Products Inc.	222d187b-aae6-410b-baeb-b2bd42f5c676	2025-01-16	Warnings	Exact identifier application number: M013
Children Pain and Fever Reliever	ACETAMINOPHEN	Target Corporation	0dd643a4-3cbc-423d-95b4-ba373b09d895	2025-01-16	Warnings	Exact identifier application number: M013
Chewable Low Dose Aspirin	ASPIRIN	TARGET CORPORATION	f934e72a-2e9f-da17-e053-6394a90a1a2e	2025-01-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	2651bf11-4d66-43ba-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M013
ASPIRIN 325 MG EC	ASPIRIN	Reliable 1 Laboratories LLC	2ab8564f-f958-7512-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 325 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	25626b46-78f8-7226-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Reliable 1 Laboratories LLC	b247fe39-7f65-e502-e053-2a95a90a08f1	2025-01-15	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	e64ce7b1-4501-4b51-b012-1882ed153b42	2025-01-13	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN 325MG	Ulai Health LLC	26942d32-d6e6-464d-8fc4-ffd9806d3e62	2025-01-12	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	WAL-MART STORES INC	a354b24e-0913-829f-e053-2995a90ad407	2025-01-11	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
55910-655-31	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