Home NDC 52412-992 Pediacare Childrens Cough and Congestion Grape
Product NDC 52412-992
11-digit product format 524120992
Labeler code 52412
Product ID 52412-992_2a815f27-d222-bc77-e063-6294a90a5f7a
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
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 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5; 100 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Congestion Grape
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020138 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 52412-992-01 Pediacare Childrens Cough and Congestion Grape 118 mL in 1 BOTTLE SYRUP 118 2 52412-992-01 Pediacare Childrens Cough and Congestion 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 52412-992 PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SYRUP [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH] 2 Current NDC, Legacy NDC, 2 package rows 20250101_9576723b-748c-45e7-bc0d-cc109b9f6735.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 52412-992-01 52412099201 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE 1 bottle 2023-01-03 0000-00-00 No No Current