FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
52204-115
11-digit product format
522040115
Labeler code
52204
Product ID
52204-115_5db40826-6093-4adc-8f00-eeaffda69e7f
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Cispharma, Inc
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-03-28
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
52204-115-992019-10-29C16284748780-1960f7f55-d913-8e05-e053-dbdaa90a074aACETAMINOPHEN CAPLETS, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52204-115-99ACETAMINOPHEN26549 in 1 DRUMTABLET265492

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET [CISPHARMA, INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET [CISPHARMA, INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACETAMINOPHEN TABLET [CISPHARMA, INC]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ACETAMINOPHEN TABLET [CISPHARMA, INC]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN TABLET [CISPHARMA, INC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET [CISPHARMA, INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN TABLET [CISPHARMA, INC]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET [CISPHARMA, INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN TABLET [CISPHARMA, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN TABLET [CISPHARMA, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52204-115ACETAMINOPHEN TABLET [CISPHARMA, INC]2Legacy NDC, 1 package rows20110406_d4d0a7fd-f4b3-4d2b-89f0-1fc3184dd231.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNd4d0a7fd-f4b3-4d2b-89f0-1fc3184dd2312
198440acetaminophen 500 MG Oral TabletSCDd4d0a7fd-f4b3-4d2b-89f0-1fc3184dd2312
198440APAP 500 MG Oral TabletSYd4d0a7fd-f4b3-4d2b-89f0-1fc3184dd2312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52204-115-995220401159926549 in 1 DRUMHistorical