Home NDC 58809-770 Childrens PediaClear 8
Product NDC 58809-770
11-digit product format 588090770
Labeler code 58809
Product ID 58809-770_404600cf-672a-ccf7-e063-6394a90a1b51
Type HUMAN OTC DRUG
Nonproprietary name Pyrilamine Maleate
Dosage form LIQUID
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-19
Substance PYRILAMINE MALEATE
Active strength 12.5 mg/15mL
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 PediaClear 8
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRILAMINE MALEATE 12.5 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2178279 Internal RxNorm lookup 2178281 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 58809-770-08 Childrens PediaClear 8 237 mL in 1 BOTTLE LIQUID 237 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-770 CHILDRENS PEDIACLEAR 8 (PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC] 8 Current NDC, Legacy NDC, 1 package rows 20241009_8e524967-d01c-4c93-9198-c42f15fe3fe0.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 58809-770-08 58809077008 237 mL in 1 BOTTLE (58809-770-08) 237 ml 2019-08-19 0000-00-00 No No Current