FDA.reportPublic FDA data

basic care acetaminophen pm

Product NDC
72288-437
11-digit product format
722880437
Labeler code
72288
Product ID
72288-437_6c749fda-de71-476d-a163-63f53d2c06df
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-11
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
basic care acetaminophen pm
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72288-437-782024-01-30C16284748780-11030e365-422c-111a-e063-dadaa90a10e2Amazon Acetaminophen PM Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-437-78basic care acetaminophen pm1 in 1 CARTONTABLET, FILM COATED12
72288-437-78basic care acetaminophen pm100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-437BASIC CARE ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 2 package rows20240722_64a0084a-e29e-4c1a-8704-13a3e1238f76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN64a0084a-e29e-4c1a-8704-13a3e1238f762
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD64a0084a-e29e-4c1a-8704-13a3e1238f762
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY64a0084a-e29e-4c1a-8704-13a3e1238f762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-437-78722880437781 BOTTLE in 1 CARTON (72288-437-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-08-110000-00-00NoNoCurrent