Home NDC 52412-920 Pediacare Childrens Cough and Cold Grape
Product NDC 52412-920
11-digit product format 524120920
Labeler code 52412
Product ID 52412-920_2a813b38-77a1-e4a0-e063-6394a90a9303
Type HUMAN OTC DRUG
Nonproprietary name BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form SYRUP
Route ORAL
Labeler RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-03
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 10; 5 mg/10mL; mg/10mL; mg/10mL
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 2027-12-31
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 Pediacare Childrens Cough and Cold Grape
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
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 52412-920-01 Pediacare Childrens Cough and Cold Grape 118 mL in 1 BOTTLE SYRUP 118 2 52412-920-01 Pediacare Childrens Cough and Cold Grape 1 in 1 CARTON SYRUP 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52412-920 PEDIACARE CHILDRENS COUGH AND COLD GRAPE (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH] 2 Current NDC, Legacy NDC, 2 package rows 20250101_fabafdc1-9dd8-4258-af49-bab1e29ad109.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 98 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 52412-920-01 52412092001 1 BOTTLE in 1 CARTON (52412-920-01) / 118 mL in 1 BOTTLE 1 bottle 2023-01-03 0000-00-00 No No Current