FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
69607-8630
11-digit product format
696078630
Labeler code
69607
Product ID
69607-8630_a93c6c12-674e-425e-9015-e40fe4b059f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WR Group, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-28
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
69607-8630-1Pain Reliever PM24 in 1 BOTTLE, PLASTICTABLET, COATED242
69607-8630-1Pain Reliever PM1 in 1 BOXTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69607-8630PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [WR GROUP, INC.]2Current NDC, 2 package rows20250331_8281771c-485c-42a9-9a1c-9a7a4298c5b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8281771c-485c-42a9-9a1c-9a7a4298c5b82
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8281771c-485c-42a9-9a1c-9a7a4298c5b82
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8281771c-485c-42a9-9a1c-9a7a4298c5b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69607-8630-1696078630011 BOTTLE, PLASTIC in 1 BOX (69607-8630-1) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2025-02-28NoNoHistorical