FDA.reportPublic FDA data

APINOPHEN

Product NDC
46084-061
11-digit product format
460840061
Labeler code
46084
Product ID
46084-061_5d9790ab-2120-4b04-a87c-d27e1e0640a2
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
A P J Laboratories Limited
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46084-061-112019-11-27C16284748780-19855e2a2-4b0c-60a7-e053-dbdaa90a05bdc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-222019-11-27C16284748780-19855e2a2-4b0c-60a7-e053-dbdaa90a05bdc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-232019-11-27C16284748780-19855e2a2-4b0c-60a7-e053-dbdaa90a05bdc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-242019-11-27C16284748780-19855e2a2-4b0c-60a7-e053-dbdaa90a05bdc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-252019-11-27C16284748780-19855e2a2-4b0c-60a7-e053-dbdaa90a05bdc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
46084-061-262019-11-27C16284748780-19855e2a2-4b0c-60a7-e053-dbdaa90a05bdc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-061-11APINOPHENEXTRA STRENGTH2 in 1 BLISTER PACKTABLET22
46084-061-22APINOPHENEXTRA STRENGTH60 in 1 BLISTER PACKTABLET602
46084-061-23APINOPHENEXTRA STRENGTH120 in 1 BLISTER PACKTABLET1202
46084-061-24APINOPHENEXTRA STRENGTH250 in 1 BLISTER PACKTABLET2502
46084-061-25APINOPHENEXTRA STRENGTH500 in 1 BLISTER PACKTABLET5002
46084-061-26APINOPHENEXTRA STRENGTH100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAPINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-061APINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [A P J LABORATORIES LIMITED]2Legacy NDC, 6 package rows20140103_c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d2
198440acetaminophen 500 MG Oral TabletSCDc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d2
198440APAP 500 MG Oral TabletSYc6ee8b69-c791-4ed0-a2bb-44a229dbcb0d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46084-061-11460840061112 in 1 BLISTER PACKHistorical
46084-061-224608400612260 in 1 BLISTER PACKHistorical
46084-061-2346084006123120 in 1 BLISTER PACKHistorical
46084-061-2446084006124250 in 1 BLISTER PACKHistorical
46084-061-2546084006125500 in 1 BLISTER PACKHistorical
46084-061-2646084006126100 in 1 BOTTLEHistorical