Home NDC 53041-577 Childrens Metapp Daytime
Product NDC 53041-577
11-digit product format 530410577
Labeler code 53041
Product ID 53041-577_985528fa-a496-4fe2-b7ae-0d894b8e26b1
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Guardian Drug Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-06-06
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Metapp Daytime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 1 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090463 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53041-577-03 Childrens Metapp Daytime 1 in 1 CARTON LIQUID 1 4 53041-577-03 Childrens Metapp Daytime 118 mL in 1 BOTTLE LIQUID 118 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-577 CHILDRENS METAPP DAYTIME (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] 4 Current NDC, Legacy NDC, 2 package rows 20241220_40565500-944b-47f2-8563-5df05469e418.zip
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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53041-577-03 53041057703 1 BOTTLE in 1 CARTON (53041-577-03) / 118 mL in 1 BOTTLE 1 bottle 2012-06-06 0000-00-00 No No Current