Home NDC 0031-2235 CHILDRENS DIMETAPP COLD AND ALLERGY
Product NDC 0031-2235
11-digit product format 000312235
Labeler code 0031
Product ID 0031-2235_5e2f8778-6595-4885-b0e4-4b94c0529271
Type HUMAN OTC DRUG
Nonproprietary name brompheniramine maleate, phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-02-07
Marketing end 2022-04-30
Substance BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0031-2235-13 00031223513 1 BOTTLE in 1 CARTON (0031-2235-13) > 118 mL in 1 BOTTLE 1 bottle 2007-02-07 0000-00-00 No No Current 0031-2235-19 00031223519 1 BOTTLE in 1 CARTON (0031-2235-19) > 237 mL in 1 BOTTLE 1 bottle 2007-02-07 0000-00-00 No No Current