FDA.reportPublic FDA data

NDC 0031-2231 - Dimetapp

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
0031-2231
Package NDCs from labels
0031-2231-89, 0031-2231-86, 0031-2231-88
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 - Haleon US Holdings LLCHaleon US Holdings LLC2024-04-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2231-86Dimetapp1 in 1 CARTONELIXIR16
0031-2231-86Dimetapp118 mL in 1 BOTTLEELIXIR1186
0031-2231-88Dimetapp118 mL in 1 BOTTLEELIXIR1186
0031-2231-88Dimetapp1 in 1 CARTONELIXIR16
0031-2231-89Dimetapp118 mL in 1 BOTTLEELIXIR1186
0031-2231-89Dimetapp1 in 1 CARTONELIXIR16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-2231DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [HALEON US HOLDINGS LLC]66 package rows20240426_4f7b773b-950f-41fb-b024-689a89019fda.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03DIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) ELIXIR [RICHMOND DIVISION OF WYETH]1
WATERINACTIVE INGREDIENT059QF0KO0RDIMETAPP (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE 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 19 of 28 · 553 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact identifier
unii: 6V9V2RYJ8N
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
unii: 6V9V2RYJ8N
Sudafed Sinus Congestion 12 HourPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCd600b5d5-7d95-4ad6-a95b-6d73502743d72024-11-08WarningsExact identifier
unii: 6V9V2RYJ8N
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
unii: 6V9V2RYJ8N
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
unii: 6V9V2RYJ8N
Sudafed Sinus 12 Hour Pressure plus PainNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC305adca3-cdae-41e5-a10a-99d9dd0fe3902024-11-08WarningsExact identifier
unii: 6V9V2RYJ8N
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
unii: 6V9V2RYJ8N
SUDOGEST NASAL DECONGESTANTPSEUDOEPHEDRINE HCLA-S Medication Solutions09feb5f0-c22d-4a1b-97a0-d5767e5f77302024-11-07WarningsExact identifier
unii: 6V9V2RYJ8N
AddiclenzBOLDO, CARDUUS MARIANUS, 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.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: OJ245FE5EU
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 2968PHW8QP
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCc01116d3-32f8-41f0-8e31-c4142265ef562024-10-24WarningsExact identifier
unii: 6V9V2RYJ8N
Guaifenesin and Pseudoephedrine HClGUAIFENESIN AND PSEUDOEPHEDRINE HCLOhm Laboratories, Inc.2521ecd3-28f3-a13c-e063-6394a90a72452024-10-23WarningsExact identifier
unii: 6V9V2RYJ8N
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEChartwell RX, LLC30f0317c-4793-4b88-8c06-c0f3cb12b3ea2024-10-21Warnings, Adverse reactionsExact identifier
unii: 6V9V2RYJ8N
unii: IXA7C9ZN03
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 506T60A25R
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Nasal DecongestantPSEUDOEPHEDRINE HCLPublix Super Markets Inc94c21df5-c631-4748-a833-288b2298055c2024-10-12WarningsExact identifier
unii: 6V9V2RYJ8N
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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