Genexa Acetaminophen PM

Product NDC
69676-0063
11-digit product format
696760063
Labeler code
69676
Product ID
69676-0063_2e9472c4-b466-e4fd-e063-6394a90ad2f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Genexa Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-17
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
Genexa Acetaminophen 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0063-2Genexa Acetaminophen PMExtra Strength100 in 1 BOTTLETABLET, COATED1005
69676-0063-2Genexa Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED15
69676-0063-5Genexa Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED15
69676-0063-5Genexa Acetaminophen PMExtra Strength50 in 1 BOTTLETABLET, COATED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0063GENEXA ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [GENEXA INC.]5Current NDC, Legacy NDC, 4 package rows20250228_d82cf6f3-a291-ca2b-e053-2a95a90a6de1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNd82cf6f3-a291-ca2b-e053-2a95a90a6de15
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDd82cf6f3-a291-ca2b-e053-2a95a90a6de15
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYd82cf6f3-a291-ca2b-e053-2a95a90a6de15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69676-0063-2696760063021 BOTTLE in 1 CARTON (69676-0063-2) / 100 TABLET, COATED in 1 BOTTLE1 bottle2022-02-170000-00-00NoNoCurrent
69676-0063-5696760063051 BOTTLE in 1 CARTON (69676-0063-5) / 50 TABLET, COATED in 1 BOTTLE1 bottle2022-02-170000-00-00NoNoCurrent