pain reliever fever reducer

Product NDC
0363-0579
11-digit product format
003630579
Labeler code
0363
Product ID
0363-0579_00ca8084-a5af-4e64-b58a-e8806fe1f101
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Walgreen Company
Application
ANDA070607
Marketing category
ANDA
Marketing start
2010-02-19
Substance
ACETAMINOPHEN
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
pain reliever fever reducer
Brand name suffix
childrens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198434

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0579-53pain reliever fever reducerchildrens12 in 1 CARTONSUPPOSITORY124
0363-0579-53pain reliever fever reducerchildrens1 in 1 BLISTER PACKSUPPOSITORY14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0579-53EA - Each0363-0579c080f625-f4d8-4fcd-82b9-1532832f0c4012024-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER FEVER REDUCER CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [WALGREEN COMPANY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER FEVER REDUCER CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0579PAIN RELIEVER FEVER REDUCER CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [WALGREEN COMPANY]4Current NDC, Legacy NDC, 2 package rows20230525_f2085b26-5778-4656-8de3-9edd83f914dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198434acetaminophen 120 MG Rectal SuppositoryPSNf2085b26-5778-4656-8de3-9edd83f914dd4
198434acetaminophen 120 MG Rectal SuppositorySCDf2085b26-5778-4656-8de3-9edd83f914dd4
198434APAP 120 MG Rectal SuppositorySYf2085b26-5778-4656-8de3-9edd83f914dd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0579-530036305795312 BLISTER PACK in 1 CARTON (0363-0579-53) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2011-03-110000-00-00NoNoCurrent