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 90 of 151 · 3,018 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRONCOCHEM COLD AND FLU CAPLETSACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL6fa52bb3-ac22-4df1-b31b-41c00181c67d2025-03-23WarningsExact identifier
unii: 362O9ITL9D
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack03475828-eae2-49ed-a1c0-8074f35c712d2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackab3646f2-1f09-4dec-9b4b-535ee9c0d3fe2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackddb58213-79b7-466b-bac4-01fd2d410cba2025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack3aa038f9-f837-466f-aa3c-68a7bd0b23882025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka5f2b04d-d1ed-4070-9239-2fd3c36994cb2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen Regular strengthACETAMINOPHENPD-Rx Pharmaceuticals, Inc.4181efc2-d183-410c-b647-233444c57e322025-03-20WarningsExact identifier
unii: 362O9ITL9D
CounterAct PainACETAMINOPHENMelaleuca, Inc.7faf76b4-7f25-377d-e053-2a91aa0a19d42025-03-20Boxed warning, WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackc9f7f4c1-c4e2-4f9b-bb02-72fb35eb43252025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackb1e520d2-0347-4399-a765-fcacbc50f2882025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackde918a56-c43e-44c7-941c-f9dd581845a72025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack58f5603e-01c9-44f8-b947-3918fd14e0492025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
unii: 362O9ITL9D
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
unii: 362O9ITL9D
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
unii: 362O9ITL9D
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
unii: 362O9ITL9D
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTARGET Corporation1fc3806e-a5c4-4a6e-951b-dfbf9f5771f12025-03-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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