Pain Relief PM

Product NDC
68998-071
11-digit product format
689980071
Labeler code
68998
Product ID
68998-071_252770f2-36e3-8ae4-e063-6294a90aae06
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-15
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 Relief 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
68998-071-03Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED13
68998-071-03Pain Relief PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-071PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [MARC GLASSMAN, INC.]3Current NDC, Legacy NDC, 2 package rows20241025_e237550d-711d-5d87-e053-2995a90affce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNe237550d-711d-5d87-e053-2995a90affce3
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDe237550d-711d-5d87-e053-2995a90affce3
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYe237550d-711d-5d87-e053-2995a90affce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68998-071-03689980071031 BOTTLE, PLASTIC in 1 CARTON (68998-071-03) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC2022-09-150000-00-00NoNoCurrent