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 30 of 152 · 3,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8ed9a9f0-d37e-5c10-e053-2a95a90a559f2026-05-01WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENSavings Distributors LLC8ed90757-833e-f4d9-e053-2995a90a29db2026-05-01WarningsExact identifier
unii: 362O9ITL9D
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
unii: 362O9ITL9D
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP6980bfc5-15e4-48ec-9346-6f09f8f789002026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCd621b526-4d9a-48a9-9a3e-d29d6aea2f312026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
unii: 362O9ITL9D
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact identifier
unii: 362O9ITL9D
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
unii: 362O9ITL9D
Up and Up Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINETarget Corporationacaffae6-2964-4529-b61a-19ddfc5fd6692026-04-29WarningsExact identifier
unii: 362O9ITL9D
EQUATE MENSTRUAL PAIN RELIEFACETAMINOPHENWALMART INC.e387ae77-27e9-455a-b708-43288411b2c12026-04-29WarningsExact identifier
unii: 362O9ITL9D
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Ibuprofen Back PainACETAMINOPHEN AND IBUPROFENAurohealth LLC62d7ce90-63a4-4383-87c9-3a458eac29bf2026-04-28WarningsExact identifier
unii: 362O9ITL9D
8HR Arthritis Pain ReliefACETAMINOPHEN 650MGCVS Pharmacy2eb6eba1-46af-32a4-e063-6294a90a499c2026-04-28WarningsExact identifier
unii: 362O9ITL9D
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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