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 42 of 45 · 883 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyabecb791-b635-482f-bb99-3ee4b7093e782022-06-24WarningsExact identifier
unii: 6V9V2RYJ8N
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.4dee850b-b170-4ef9-ae02-3db9bfa05abe2022-06-08WarningsExact identifier
unii: 6V9V2RYJ8N
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
unii: B22547B95K
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INCc857bcd9-6696-40d5-93c0-65097598cd4b2022-04-08WarningsExact identifier
unii: 6V9V2RYJ8N
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEProficient Rx LP1b79a7d8-a8f4-4525-8b94-3e317fc5a7172022-04-01Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
unii: IXA7C9ZN03
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.a63da38d-1fea-4ee0-a70b-55c891a5ebcc2022-02-11Exact identifier
unii: B22547B95K
Sodium Citrate Blood-Pack Units, (PL 146 Plastic)ANTICOAGULANT SODIUM CITRATE SOLUTIONFenwal, Inc.ac8971a9-36d0-43c9-9121-ba5e58c28bed2022-02-11Exact identifier
unii: B22547B95K
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCd139fd8d-66fd-4484-8e78-ed90c505d9992022-02-08WarningsExact identifier
unii: 6V9V2RYJ8N
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAurohealth LLC6adf9292-b4af-4cb4-99f3-dda03734570a2022-01-21WarningsExact identifier
unii: 6V9V2RYJ8N
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
unii: B22547B95K
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
unii: B22547B95K
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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