Home NDC 58809-925 TexaClear Kids Allergy
Product NDC 58809-925
11-digit product format 588090925
Labeler code 58809
Product ID 58809-925_413912d6-8c4d-3486-e063-6294a90a00bb
Type HUMAN OTC DRUG
Nonproprietary name Chlophedianol HCl Pyrilamine Maleate
Dosage form LIQUID
Route ORAL
Labeler GM Pharmaceuticals, Inc.
Application M12
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-06-15
Substance CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength 12.5; 25 mg/30mL; mg/30mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 58809-925 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58809-925 58809-925-08 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 TexaClear Kids Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg/30mL PYRILAMINE MALEATE 25 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 69QQ58998Y Internal UNII lookup R35D29L3ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1808189 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 58809-925-08 TexaClear Kids Allergy 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 58809-925 TEXACLEAR KIDS ALLERGY (CHLOPHEDIANOL HCL PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241009_3b8a686f-d8e8-56db-e054-00144ff8d46c.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 1 of 1 · 2 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 58809-925-08 58809092508 237 mL in 1 BOTTLE (58809-925-08) 237 ml 2016-06-15 0000-00-00 No No Current