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 45 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ASPIRIN LOW DOSE	ASPIRIN LOW DOSE	AARNA USA INC.	347edc8f-6391-b75e-e063-6394a90a1cf5	2025-05-06	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Infants Pain and Fever	ACETAMINOPHEN	Amerisource Bergen	2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2	2025-05-06	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	AARNA USA INC.	34157f6a-3031-4388-e063-6394a90a670f	2025-05-01	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	HF Acquisition Co LLC, DBA HealthFirst	2553d0cb-3f5c-7ea0-e063-6294a90a3cd4	2025-05-01	Warnings, Adverse reactions	Exact identifier application number: M013
Aspirin 81mg Enteric Coated	ASPIRIN	Advanced Rx LLC	606067bb-b07f-444e-9465-d1e187735f3a	2025-05-01	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	AARNA USA INC.	33f0e822-28af-9bb2-e063-6294a90a5175	2025-04-29	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	27fcca07-f845-77fe-e063-6394a90aa2f8	2025-04-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	46a6bbb9-ccd1-47a8-9e58-485f71f57063	2025-04-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	061c91d5-5aa8-4556-a344-197b7e8a10b8	2025-04-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	A-S Medication Solutions	c4f0f591-8501-4c6d-bf8e-ca3068ff65b5	2025-04-24	Warnings	Exact identifier application number: M013
Extra Strength No-Pain	ACETAMINOPHEN	Safrel Pharmaceuticals, LLC.	873f01dd-0701-5fd3-e053-2a95a90a6463	2025-04-23	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Chain Drug Consortium	60d4b392-6ed0-4115-8154-24eaf72504a5	2025-04-16	Warnings	Exact identifier application number: M013
Premsyn pms Premenstrual Pain Relief	ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE	Focus Consumer Healthcare, LLC	5b6f6260-69ae-cfeb-e053-2a91aa0a6b49	2025-04-14	Warnings	Exact identifier application number: M013
BackAid Max	ACETAMINOPHEN, PAMABROM	Kobayashi Healthcare International, Inc.	fb9a5647-b7c9-4820-b148-91060e34cb83	2025-04-14	Warnings	Exact identifier application number: M013
RIGHT REMEDIES LOW DOSE Aspirin 81mg	ASPIRIN	Strive Pharmaceuticals Inc.	322c0e50-cf75-51ab-e063-6294a90a9235	2025-04-14	Warnings	Exact identifier application number: M013
Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange	ASPIRIN	Bayer HealthCare LLC.	0c6ae05f-760f-34d1-e054-00144ff88e88	2025-04-11	Warnings	Exact identifier application number: M013
Arthriten Inflammatory Pain Formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Kobayashi Healthcare International, Inc	c280ca89-4fb5-4050-90ee-d706a550a1ef	2025-04-11	Warnings	Exact identifier application number: M013
Bayer Back and Body Extra Strength	ASPIRIN,CAFFEINE	Bayer HealthCare LLC.	0c77c484-6caf-12ca-e054-00144ff88e88	2025-04-10	Warnings	Exact identifier application number: M013
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	NuCare Pharmaceuticals, Inc.	324937c3-c558-bc79-e063-6294a90acc8e	2025-04-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN 500MG	CVS Pharmacy, Inc.	1fde6487-6682-99a3-e063-6294a90a3670	2025-04-04	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