Pain Reliever PM

Product NDC
57243-235
11-digit product format
572430235
Labeler code
57243
Product ID
57243-235_c3e081b6-59d1-472c-a56f-579cf8b0e222
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Reliever PM
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57243-235-15Pain Reliever PMExtra Strength1 in 1 CARTONTABLET, FILM COATED114
57243-235-15Pain Reliever PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-235PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SALADO SALES, INC.]13Current NDC, Legacy NDC, 2 package rows20240825_aef30709-f33d-48ff-b2d4-0639ffbd1ffd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNaef30709-f33d-48ff-b2d4-0639ffbd1ffd14
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDaef30709-f33d-48ff-b2d4-0639ffbd1ffd14
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYaef30709-f33d-48ff-b2d4-0639ffbd1ffd14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57243-235-15572430235151 BOTTLE, PLASTIC in 1 CARTON (57243-235-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1994-05-150000-00-00NoNoCurrent