FDA.reportPublic FDA data

NDC 51672-2115-0 - Feverall Childrens

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-2115
Requested NDC
51672-2115-0
Package NDCs from labels
51672-2115-0, 51672-2115-2, 51672-2115-4
Manufacturer
Sun Pharmaceutical Industries, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC
Effective date
2026-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Feverall ® Children'sSun Pharmaceutical Industries, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC2026-08-24HUMAN OTC DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 95 of 151 · 3,018 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect_Rxe8a7c995-e473-ca87-e053-2995a90a5b802025-01-22Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE/APAPHYDROCODONE/APAPDirect_Rxefe3b2eb-5c26-3783-e053-2995a90a6ba82025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PercocetOXYCODONE/APAPDirect_Rxee151649-b52a-0a51-e053-2a95a90a6c352025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
NorcoHYDROCODONE/APAPDirect_Rxee248dfd-7aa7-7dcc-e053-2995a90af19f2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rxf0e66441-668a-7ab8-e053-2995a90aba4f2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN PMACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MGUlai Health LLCd4a568c9-a721-48d1-aebc-fc65444947ce2025-01-20WarningsExact identifier
unii: 362O9ITL9D
PharbetolACETAMINOPHEN 500MGUlai Health LLCc9d3cee1-531c-439f-ae19-07acd366aad62025-01-20WarningsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRxcc0e654d-1eaa-7d17-e053-2995a90ab1db2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
unii: 362O9ITL9D
Kroger DayTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Co.2499210b-c162-76b9-e063-6294a90adbc32025-01-17WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepackb9df47cf-f999-49d8-95b9-374c0539b6a12025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Little Remedies Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
unii: 362O9ITL9D
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
unii: 362O9ITL9D
Dye Free Childrens AcetaminophenACETAMINOPHENPrecision Dose Inc.5cc698fa-0841-4851-ae21-0aac8b40eb0a2025-01-16WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENRITE AIDd1f18c32-c043-7c97-e053-2a95a90a203e2025-01-16WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINESUNRISE PHARMACEUTICAL, INCee7630f8-f4b8-4eb0-b34d-d908567030c42025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Children Pain and Fever RelieverACETAMINOPHENTarget Corporation0dd643a4-3cbc-423d-95b4-ba373b09d8952025-01-16WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.