FDA.reportPublic FDA data

Extra Strength Pain Relief PM

Product NDC
63941-095
11-digit product format
639410095
Labeler code
63941
Product ID
63941-095_45b0d446-7d54-c0c8-e063-6294a90a5230
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-02-01
Marketing end
2028-03-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Pain Relief PM

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
63941-095-02Extra Strength Pain Relief PM1 in 1 CARTONTABLET, COATED14
63941-095-02Extra Strength Pain Relief PM50 in 1 BOTTLE, PLASTICTABLET, COATED504
63941-095-03Extra Strength Pain Relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1004
63941-095-03Extra Strength Pain Relief PM1 in 1 CARTONTABLET, COATED14
63941-095-09Extra Strength Pain Relief PM2 in 1 CARTONTABLET, COATED24
63941-095-09Extra Strength Pain Relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-095EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [VALU MERCHANDISERS COMPANY]3Current NDC, Legacy NDC, 6 package rows20241017_f8820150-feec-4062-85bb-14525ddf691f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf8820150-feec-4062-85bb-14525ddf691f4
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf8820150-feec-4062-85bb-14525ddf691f4
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf8820150-feec-4062-85bb-14525ddf691f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-095-02639410095021 BOTTLE, PLASTIC in 1 CARTON (63941-095-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2010-02-012027-10-31NoNoCurrent
63941-095-03639410095031 BOTTLE, PLASTIC in 1 CARTON (63941-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2011-10-042027-12-31NoNoCurrent
63941-095-09639410095092 BOTTLE, PLASTIC in 1 CARTON (63941-095-09) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2012-02-032028-03-31NoNoCurrent