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 16 of 28 · 553 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc821c3880-303d-470a-af6a-e13be7ab313f2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd3260111b-35da-4f95-8081-51eae4b1ef452025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and ColdNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC638a9664-4129-46fd-9ba1-d660a7366c9f2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
topcare all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDETopco Associates LLC103df878-1455-414f-94cb-5b32a2d3e4b82025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
equate allergy relief d nasal decongestantCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEWALMART INC.7b7b8cce-ede6-47c6-91c8-88fd94cb292d2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEKroger Company2f1df816-311b-444a-8040-21227016614b2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacyfe26cba3-5b84-462c-ac2b-e9e09612ad1d2025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
Rugby Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratories5c6ac9a2-4f0a-4297-9b83-988d54598f752025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
signature care allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDESafeway8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c802025-02-12WarningsExact identifier
unii: 6V9V2RYJ8N
allergy relief dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEH E Bb3ca8aae-04f2-4c00-9fb5-ce3ed7e6f1bb2025-02-11WarningsExact identifier
unii: 6V9V2RYJ8N
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
kirkland signature aller tec dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECostco Wholesale Companya8e57b21-4622-4315-8e8e-437243be2fe12025-02-04WarningsExact identifier
unii: 6V9V2RYJ8N
good sense all day allergy dCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companyc7154370-5d91-4dc4-90ed-1d07d9bc59432025-02-04WarningsExact identifier
unii: 6V9V2RYJ8N
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 2968PHW8QP
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC10a8a74b-11d1-490e-87e7-d705fe0e76022025-01-21WarningsExact identifier
unii: 6V9V2RYJ8N
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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