FDA.reportPublic FDA data

NDC 0031-2251 - Dimetapp Paediatric

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
0031-2251
Package NDCs from labels
0031-2251-12, 0031-2251-04, 0031-2251-05
Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dimetapp Paediatric - Haleon US Holdings LLCHaleon US Holdings LLC2024-04-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2251-04Dimetapp Paediatric118 mL in 1 BOTTLEELIXIR1187
0031-2251-04Dimetapp Paediatric1 in 1 CARTONELIXIR17
0031-2251-05Dimetapp Paediatric1 in 1 CARTONELIXIR17
0031-2251-05Dimetapp Paediatric118 mL in 1 BOTTLEELIXIR1187
0031-2251-12Dimetapp Paediatric1 in 1 CARTONELIXIR17
0031-2251-12Dimetapp Paediatric118 mL in 1 BOTTLEELIXIR1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-2251DIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [HALEON US HOLDINGS LLC]76 package rows20240426_e180b654-0e83-4874-b947-30d19d2bb7d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03DIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
WATERINACTIVE INGREDIENT059QF0KO0RDIMETAPP PAEDIATRIC (BROMPHENERAMINE MALEATE, PSEDUEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1

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 2 of 46 · 917 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: XF417D3PSL
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
foster and thrive mucus relief dGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLC12460719-ff39-49b3-95f8-85e547ad00762026-08-04WarningsExact identifier
unii: 6V9V2RYJ8N
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
LEADER 12HR ALLERGY AND CONGESTION RELIEFFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader1400014a-2fa6-4a4f-8eb9-85ac049b4b702026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
EQUATE ALLERGY RELIEF DFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.6daeb739-a112-4a37-abbb-0bbc41b42df32026-08-03WarningsExact identifier
unii: 6V9V2RYJ8N
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: 6V9V2RYJ8N
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
unii: 6V9V2RYJ8N
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: 6V9V2RYJ8N
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
unii: 6V9V2RYJ8N
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDESportpharm LLCf3afca82-ba8f-4741-8332-b7939aa0ee5e2026-07-23Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
unii: IXA7C9ZN03
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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