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 9 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Kids Pain and Fever ACETAMINOPHEN CalmCo LLC 5534a784-a7b1-5599-e063-6294a90a7961 2026-06-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Select Consumer Group LLC 529d3a51-a248-7c02-e063-6294a90a10ae 2026-06-27 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sportpharm LLC 830ffcaa-7ff8-4732-bc84-6a8c5e78722d 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Strategic Sourcing Services LLC ea2ef485-429e-4c63-ba7b-0a6b32892ad2 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association, Inc. 055d8420-c189-4a9e-acdc-21627935c8eb 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Topco Associates, LLC 5f32cf74-dbea-496c-ba23-2040ea354f40 2026-06-25 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Salado Sales, Inc. cf3139a5-e36e-48e3-bb6c-e102b0cec555 2026-06-25 Warnings Exact identifier application number: M013 Pain Relief Aspirin ASPIRIN Rite Aid Corporation bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 2026-06-25 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN Walgreen Company 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef 2026-06-25 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Neo-Lubrina Children ACETAMINOPHEN OPMX LLC 5476f4cf-4a5d-2287-e063-6394a90a5ed5 2026-06-17 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013
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