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 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediacare Childrens Acetaminophen Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	596372c7-eca3-4527-8e22-ab0751e2526b	2024-12-30	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	BAYER GENUINE ASPIRIN	Lil' Drug Store Products, Inc.	d17834d7-cb3e-6bf2-e053-2a95a90ae5c1	2024-12-30	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fd2b46-683e-4cf5-e053-2995a90a5512	2024-12-30	Warnings	Exact identifier application number: M013
Night Time Severe Cold and Cough Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Chain Drug Consortium, LLC	c8e9b57b-83e9-46c5-9791-02c4c2b94004	2024-12-29	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC.	1608b4f0-bf20-4024-b8f2-20a4df7a4b21	2024-12-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	f6a9ea44-08b8-4a33-bfbd-68cb2d852c39	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	cfc7eac3-35be-4002-b8ef-be1dfc8caf69	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	a3031139-4709-43f2-95a8-89840c595f7f	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	WALGREENS CO.	98bb28ed-d146-ca3d-e053-2a95a90a9eaf	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg	ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG	WALGREENS CO.	982faa74-d498-cd1e-e053-2995a90afa1e	2024-12-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	11bf6e1b-aed9-4f8f-9f03-ea911ae9f702	2024-12-23	Warnings	Exact identifier application number: M013
Rugby Regular Strength Acetaminophen	ACETAMINOPHEN	RUGBY LABORATORIES	295b0d00-4d4a-405f-9325-d01c5d4f3ed4	2024-12-20	Warnings	Exact identifier application number: M013
Walgreens Pain Relief Powder	ASPIRIN AND CAFFEINE	Walgreens Co.	61493d34-2432-4683-9b32-e1851a4337be	2024-12-18	Warnings	Exact identifier application number: M013
Reese Headache Powders	ASPIRIN AND CAFFEINE	Reese Pharmaceutical Co	386f7a6c-4bfc-4140-a67b-07f6b520d58f	2024-12-18	Warnings	Exact identifier application number: M013
NobleAid PAIN RELIEVER	ASPIRIN	Noble Otc LLC	aa08e488-2f69-4d7e-86ba-ccfad563edcf	2024-12-18	Warnings	Exact identifier application number: M013
Dollar General Headache Powders	ASPIRIN AND CAFFEINE	Dolgencorp, LLC	11b0271b-d65c-49c4-a081-d71044a0e04c	2024-12-18	Warnings	Exact identifier application number: M013
Family Wellness Pain Relief Powder	ASPIRIN AND CAFFEINE	Family Dollar Services Inc	b2e55de7-3c36-49cc-8f7f-1013fd1ec359	2024-12-18	Warnings	Exact identifier application number: M013
Best Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Value Merch	a95b9b22-ea5c-4a02-b35d-c8ae1e117604	2024-12-18	Warnings	Exact identifier application number: M013
Walmart Pain Relief Powder	ASPIRIN AND CAFFEINE	Walmart	c69aa61f-6a74-40a3-8737-195fa545e261	2024-12-18	Warnings	Exact identifier application number: M013
Quality Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Chain Drug Marketing Association	8e1f4057-4968-4523-9b3f-55aea421b674	2024-12-18	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	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