Pain Reliever PM

Product NDC: 57243-235
11-digit product format: 572430235
Labeler code: 57243
Product ID: 57243-235_ac1496d2-7b9e-468f-acdf-607a6efd98e8
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Salado Sales, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1994-05-15
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 Reliever 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
aef30709-f33d-48ff-b2d4-0639ffbd1ffd	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	Strength	SPL version
57243-235-15	Pain Reliever PMExtra Strength	1 in 1 CARTON	TABLET, FILM COATED	1		14
57243-235-15	Pain Reliever PMExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57243-235	PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240825_aef30709-f33d-48ff-b2d4-0639ffbd1ffd.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFANTS PAIN AND FEVER	ACETAMINOPHEN	Amazon.com Services LLC	112076c4-cac2-45ab-9c77-5573edae7180	2026-07-10	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Wal-Mart Stores Inc	8ae16aa2-54bc-4c1a-aa36-93524199a67b	2026-07-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Wildman Business Group	943c8f49-e65e-40bc-b364-3274df4d21a2	2026-07-09	Warnings	Exact identifier application number: M013
Aspirin Regular Strength	ASPIRIN	FOODHOLD U.S.A., LLC	9e09b4fb-e015-45ea-8b1c-27faf65572aa	2026-07-09	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Walgreen Company	f13fb7e9-50ea-4e2c-a442-38b1b5b315d7	2026-07-09	Warnings	Exact identifier application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60	ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETS	Health Pharma USA LLC	34eb8a9b-d0ee-13e8-e063-6294a90a2fef	2026-07-08	Warnings	Exact identifier application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg	ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG	Health Pharma USA LLC	3590d417-272b-ae4d-e063-6394a90a5dc6	2026-07-08	Warnings	Exact identifier application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN	ACETAMINOPHEN	Cabinet Health P.B.C.	88884253-5a79-4ac1-b8ce-03966d8b509d	2026-07-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Health Pharma USA LLC	671adabe-5f82-4599-a133-3f67ccb34079	2026-07-07	Warnings	Exact identifier application number: M013
Pain Reliever Plus	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Rugby Laboratories	c3df1652-96a8-6043-e053-2995a90a2d26	2026-07-07	Warnings	Exact identifier application number: M013
Rapidol Aspirin	ASPIRIN	Pharmadel LLC	00d9ab0d-ff25-784f-e063-6294a90a8497	2026-07-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Trifecta Pharmaceuticals USA LLC	227cefca-acc4-41d0-e063-6394a90a35b9	2026-07-06	Warnings	Exact identifier application number: M013
Extra Strength Pain Aid	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Hi-Tech Nutaceuticals, LLC	a39e4b99-700d-0f5c-e053-2a95a90a6bd3	2026-07-06	Warnings	Exact identifier application number: M013
Nighttime Sleep Aid	ACETAMINOPHEN, DIPHENHYDRAMINE	Hi-Tech Nutraceuticals, LLC	a39e2bd6-3d0a-642b-e053-2995a90a42a0	2026-07-06	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a36be487-7a36-550f-e053-2a95a90a95c1	2026-07-06	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a39c524e-c131-d7fb-e053-2995a90a785b	2026-07-06	Warnings	Exact identifier application number: M013
PAIN RELIEVER	ASPIRIN 81 MG	Health Pharma USA, LLC	d60aed37-3a9e-46d1-e053-2995a90a1d1f	2026-07-06	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Select Consumer Group	55d0dceb-c9a9-778e-e063-6294a90a2ad7	2026-07-04	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Select Consumer Group	3ca776c2-47ed-5107-e063-6394a90ac5df	2026-07-03	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Rugby Laboratories	f7ca9f4a-f8ef-46d2-9536-b69541e6653d	2026-07-02	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

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	aef30709-f33d-48ff-b2d4-0639ffbd1ffd	14
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	aef30709-f33d-48ff-b2d4-0639ffbd1ffd	14
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	aef30709-f33d-48ff-b2d4-0639ffbd1ffd	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57243-235-15	57243023515	1 BOTTLE, PLASTIC in 1 CARTON (57243-235-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	1994-05-15	0000-00-00	No	No	Current