FDA.reportPublic FDA data

Feverall

Product NDC
51672-2115
11-digit product format
516722115
Labeler code
51672
Product ID
51672-2115_49e3a099-4616-d038-e063-6394a90a90a6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA018337
Marketing category
NDA
Marketing start
2013-12-12
Substance
ACETAMINOPHEN
Active strength
120 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Feverall
Brand name suffix
Childrens
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198434, 209353

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2115-0Feverall Childrens1 in 1 BLISTER PACKSUPPOSITORY17
51672-2115-2Feverall Childrens6 in 1 CARTONSUPPOSITORY67
51672-2115-4Feverall Childrens50 in 1 CARTONSUPPOSITORY507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2115-2EA - Each51672-21157659ca73-8890-47ae-a224-c2ab49a095fd12014-09-03
51672-2115-4EA - Each51672-21150a358158-1f9b-444c-a8a1-2ad54dfbc93d12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DFEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DFEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4FEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]2
hydrogenated palm kernel oilINACTIVE INGREDIENTFM8D1RE2VPFEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]2
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RFEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2115FEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [TARO PHARMACEUTICALS U.S.A. INC.]6Current NDC, Legacy NDC, 3 package rows20241211_861e2987-5473-45b0-b2a6-f980a9b0e809.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198434acetaminophen 120 MG Rectal SuppositoryPSN861e2987-5473-45b0-b2a6-f980a9b0e8097
209353Feverall Children's 120 MG Rectal SuppositoryPSN861e2987-5473-45b0-b2a6-f980a9b0e8097
209353acetaminophen 120 MG Rectal Suppository [Feverall]SBD861e2987-5473-45b0-b2a6-f980a9b0e8097
198434acetaminophen 120 MG Rectal SuppositorySCD861e2987-5473-45b0-b2a6-f980a9b0e8097
198434APAP 120 MG Rectal SuppositorySY861e2987-5473-45b0-b2a6-f980a9b0e8097
209353APAP 120 MG Rectal Suppository [Feverall]SY861e2987-5473-45b0-b2a6-f980a9b0e8097
209353Feverall Children's 120 MG Rectal SuppositorySY861e2987-5473-45b0-b2a6-f980a9b0e8097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2115-0516722115001 in 1 BLISTER PACKHistorical
51672-2115-2516722115026 BLISTER PACK in 1 CARTON (51672-2115-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) 6 blister pack2013-12-120000-00-00NoNoCurrent
51672-2115-45167221150450 BLISTER PACK in 1 CARTON (51672-2115-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) 50 blister pack2013-12-120000-00-00NoNoCurrent