FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
70677-1149
11-digit product format
706771149
Labeler code
70677
Product ID
70677-1149_69a8d4f7-a4b9-4685-be9f-166047114b02
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-01
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
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
70677-1149-1Pain Reliever PM1 in 1 BOXTABLET, COATED13
70677-1149-1Pain Reliever PM50 in 1 BOTTLE, PLASTICTABLET, COATED503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1149PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20250207_5d174187-cf89-41ff-9a64-10e0276daf17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN5d174187-cf89-41ff-9a64-10e0276daf173
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD5d174187-cf89-41ff-9a64-10e0276daf173
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY5d174187-cf89-41ff-9a64-10e0276daf173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70677-1149-1706771149011 BOTTLE, PLASTIC in 1 BOX (70677-1149-1) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2023-04-01NoNoHistorical