Home NDC 58809-389 TEXACLEAR PAIN RELIEVER
Product NDC 58809-389
11-digit product format 588090389
Labeler code 58809
Product ID 58809-389_4139160a-f694-24ee-e063-6294a90a1f52
Type HUMAN OTC DRUG
Nonproprietary name Caffeine, Choline salicylate
Dosage form LIQUID
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-12-14
Substance CHOLINE SALICYLATE; CAFFEINE
Active strength 870; 65 mg/30mL; mg/30mL
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
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 TEXACLEAR PAIN RELIEVER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLINE SALICYLATE 870 mg/30mL CAFFEINE 65 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KD510K1IQW Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1994320 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 58809-389-08 TEXACLEAR PAIN RELIEVER 237 mL in 1 BOTTLE LIQUID 237 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-389 TEXACLEAR PAIN RELIEVER (CAFFEINE, CHOLINE SALICYLATE) LIQUID [GM PHARMACEUTICALS, INC] 8 Current NDC, Legacy NDC, 1 package rows 20241009_065bd10c-3bcf-486f-a49c-40544127007f.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 83 · 1,657 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 58809-389-08 58809038908 237 mL in 1 BOTTLE (58809-389-08) 237 ml 2017-12-14 0000-00-00 No No Current