FDA.reportPublic FDA data

Acetaminophen PM

Product NDC
81522-095
11-digit product format
815220095
Labeler code
81522
Product ID
81522-095_2499e0c3-bbc3-58aa-e063-6294a90a4ed5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
FSA STORE INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-02
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-095-03Acetaminophen PM1 in 1 CARTONTABLET, COATED13
81522-095-03Acetaminophen PM100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-095ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.]3Current NDC, 2 package rows20241018_f4322f34-ac19-371e-e053-2a95a90ac864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf4322f34-ac19-371e-e053-2a95a90ac8643
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf4322f34-ac19-371e-e053-2a95a90ac8643
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf4322f34-ac19-371e-e053-2a95a90ac8643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81522-095-03815220095031 BOTTLE, PLASTIC in 1 CARTON (81522-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-05-02NoNoHistorical