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 39 of 45 · 898 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: PDC6A3C0OX
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
unii: PDC6A3C0OX
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
unii: PDC6A3C0OX
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: XF417D3PSL
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLWALGREEN CO.1cc6e3f0-64f7-4974-a62c-5db46ca9e7c52023-09-08WarningsExact identifier
unii: 6V9V2RYJ8N
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
unii: XF417D3PSL
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: OJ245FE5EU
unii: 506T60A25R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
unii: H3R47K3TBD
unii: 506T60A25R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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