FDA.reportPublic FDA data

pain relief PM

Product NDC
41250-195
11-digit product format
412500195
Labeler code
41250
Product ID
41250-195_243471b8-1836-664c-e063-6294a90abce7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-01
Marketing end
2026-09-30
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
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
41250-195-02pain relief PM1 in 1 CARTONTABLET, COATED13
41250-195-02pain relief PM50 in 1 BOTTLE, PLASTICTABLET, COATED503
41250-195-03pain relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1003
41250-195-03pain relief PM1 in 1 CARTONTABLET, COATED13
41250-195-09pain relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1003
41250-195-09pain relief PM2 in 1 CARTONTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-195PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [MEIJER]3Current NDC, Legacy NDC, 6 package rows20241013_8504a0ea-b020-58ba-e053-2a91aa0a81a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8504a0ea-b020-58ba-e053-2a91aa0a81a83
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8504a0ea-b020-58ba-e053-2a91aa0a81a83
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8504a0ea-b020-58ba-e053-2a91aa0a81a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41250-195-02412500195021 BOTTLE, PLASTIC in 1 CARTON (41250-195-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2017-05-012026-09-30NoNoCurrent
41250-195-03412500195031 BOTTLE, PLASTIC in 1 CARTON (41250-195-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2017-05-012026-09-30NoNoCurrent
41250-195-09412500195092 BOTTLE, PLASTIC in 1 CARTON (41250-195-09) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2017-05-012026-09-30NoNoCurrent