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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	United Natural Foods, Inc. dba UNFI	739237a5-cc62-8ad6-e053-2991aa0a91f8	2024-12-17	Warnings	Exact identifier application number: M013
NOTTS - Muscle Aches and Pain	ACETAMINOPHEN	VIVUNT PHARMA LLC	e6741300-4573-2580-e053-2a95a90a599c	2024-12-17	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever, Caseys 4good	ACETAMINOPHEN 500MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fc5340-c224-e02b-e053-2a95a90a5297	2024-12-16	Warnings	Exact identifier application number: M013
Pain Reliever, Caseys 4good	ACETAMINOPHEN 500 MG, TABLET	Lil' Drug Store Products, Inc.	039d2cf1-57f6-4d9d-e063-6394a90a5492	2024-12-16	Warnings	Exact identifier application number: M013
Extra Strength Headache, Caseys 4good	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0425c6a8-a3ea-24ad-e063-6294a90ae15a	2024-12-16	Warnings	Exact identifier application number: M013
Lil Drug Store Childrens Pain and Fever	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	5fcd41ad-449f-4090-be19-eae4171de891	2024-12-16	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e75551-1e50-9896-e053-2a95a90aafd4	2024-12-14	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e5df0e-06d3-6f72-e053-2995a90a2d07	2024-12-14	Warnings	Exact identifier application number: M013
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	2928e140-c868-5bf5-e063-6394a90ab024	2024-12-13	Warnings	Exact identifier application number: M013
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	b8ee568c-80cf-4e35-865e-35516bdab0fd	2024-12-13	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	c0de0bd2-4868-46dc-a20f-3ca02caaa26b	2024-12-11	Warnings	Exact identifier application number: M013
Rite Aid Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Rite Aid	b4797380-9cef-d640-e053-2a95a90a0665	2024-12-11	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE	Tower Laboratories Ltd	44babed8-cf38-1c12-e054-00144ff8d46c	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	b5e2300a-b77b-53cc-e053-2a95a90a7a6e	2024-12-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH Headache Relief geltabs	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	b432771a-4f7d-4d39-a038-d1561d8f6708	2024-12-11	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6	2024-12-10	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	UNFI	e689c9e3-dd4d-c646-e053-2a95a90a4b6a	2024-12-09	Warnings	Exact identifier application number: M013
DrKids Childrens Pain and Fever	ACETAMINOPHEN 80MG/PIECE	CalmCo LLC	ff4b0528-39a0-80d5-e053-6394a90a8a83	2024-12-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	972f09a7-2aa1-4b1b-a6dc-2c4578a07803	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6feff0a-3347-194d-e053-2a95a90acd20	2024-12-05	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