FDA.reportPublic FDA data

EXTRA STRENGTH PAIN RELIEF PM

Product NDC
68210-0099
11-digit product format
682100099
Labeler code
68210
Product ID
68210-0099_ee515a9d-9b0f-ca05-e053-2a95a90ab099
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-04-10
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68210-0099-2EXTRA STRENGTH PAIN RELIEF PM24 in 1 BOTTLETABLET248
68210-0099-2EXTRA STRENGTH PAIN RELIEF PM1 in 1 CARTONTABLET18
68210-0099-3EXTRA STRENGTH PAIN RELIEF PM1 in 1 CARTONTABLET18
68210-0099-3EXTRA STRENGTH PAIN RELIEF PM50 in 1 BOTTLETABLET508
68210-0099-5EXTRA STRENGTH PAIN RELIEF PM375 in 1 PACKAGETABLET3758

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0099EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SPIRIT PHARMACEUTICAL LLC]8Legacy NDC, 5 package rows20250101_e8f71439-5c07-44ab-9c4d-42ed41eb159a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNe8f71439-5c07-44ab-9c4d-42ed41eb159a8
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDe8f71439-5c07-44ab-9c4d-42ed41eb159a8
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYe8f71439-5c07-44ab-9c4d-42ed41eb159a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-0099-2682100099021 BOTTLE in 1 CARTON (68210-0099-2) > 24 TABLET in 1 BOTTLE1 bottle2018-04-110000-00-00NoNoCurrent
68210-0099-3682100099031 BOTTLE in 1 CARTON (68210-0099-3) > 50 TABLET in 1 BOTTLE1 bottle2018-04-110000-00-00NoNoCurrent
68210-0099-568210009905375 TABLET in 1 PACKAGE (68210-0099-5) 375 tablet2020-03-120000-00-00NoNoCurrent