Pain Relief PM

Product NDC
68998-195
11-digit product format
689980195
Labeler code
68998
Product ID
68998-195_252639e3-38cf-04f0-e063-6294a90a94ad
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
2022-10-05
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
68998-195-02Pain Relief PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED503
68998-195-02Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-195PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [MARC GLASSMAN, INC.]3Current NDC, Legacy NDC, 2 package rows20241025_e221bbce-83de-0f03-e053-2995a90abca5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNe221bbce-83de-0f03-e053-2995a90abca53
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDe221bbce-83de-0f03-e053-2995a90abca53
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYe221bbce-83de-0f03-e053-2995a90abca53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68998-195-02689980195021 BOTTLE, PLASTIC in 1 CARTON (68998-195-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2022-10-050000-00-00NoNoCurrent