Home NDC 58809-389-08 TEXACLEAR PAIN RELIEVER
Product NDC 58809-389
Requested package NDC 58809-389-08
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 72 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Tension Headache ACETAMINOPHEN, CAFFEINE Haleon US Holdings LLC 12c074d1-81ac-47d2-8747-b018cda0058a 2024-03-13 Warnings Exact identifier application number: M013 Menstrual Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE Strive Pharmaceuticals Inc. 78c12459-3b27-4ed0-943d-520794eb438d 2024-03-07 Warnings Exact identifier application number: M013 Pain Reliever fever Reducer Extra Strength ACETAMINOPHEN CVS Pharmacy 7b5263ad-01b7-4fc5-9384-4da8efe89e35 2024-03-06 Warnings Exact identifier application number: M013 Excedrin Extra Strength Geltabs ACETAMINOPHEN, ASPRIN, CAFFEINE Haleon US Holdings LLC 11a8439b-0159-4351-b0f5-fe7fad6a33c0 2024-03-05 Warnings Exact identifier application number: M013 Winco Foods Effervescent Pain Relief ASPIRIN Winco Foods, LLC 128afdd7-a9d1-8957-e063-6294a90af569 2024-03-05 Warnings Exact identifier application number: M013 Aspirin Low Dose Safety Coated ASPIRIN Care One (Retail Business Services, LLC.) 6659e103-fa03-4de0-af42-d2fbd548a87c 2024-03-05 Warnings Exact identifier application number: M013 Dolex Children Pain and Fever ACETAMINOPHEN Pharmadel LLC f9158463-aeb1-5de0-e053-6294a90a748b 2024-03-04 Warnings Exact identifier application number: M013 SEDALMEX FORTE ACETAMINOPHEN, ASPIRIN, CAFFEINE Belmora LLC 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d 2024-02-28 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AMERISOURCE BERGEN 2b923a97-836c-4dac-a8c0-3047a35fb62e 2024-02-23 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL BJWC (Berkley & Jensen / BJ's) b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 2024-02-22 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack 31a41976-7f65-42d7-acf5-de9c2c5ca58e 2024-02-20 Warnings Exact identifier application number: M013 Publix Fast Relief Effervescent - Original Flavor ASPIRIN PUBLIX SUPER MARKETS INC. 0a342f72-45fd-3e12-e063-6394a90ae33e 2024-02-16 Warnings Exact identifier application number: M013 Equaline Effervescent Pain Reliever ASPIRIN UNITED NATURAL FOODS, INC. DBA UNFI 0761299a-e913-7665-e063-6394a90a6003 2024-02-16 Warnings Exact identifier application number: M013 TopCare Effervescent Pain Relief ASPIRIN TOPCO ASSOCIATES LLC 075f36e1-110c-e839-e063-6294a90a89d7 2024-02-16 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 115d0b4f-6f0f-79a9-e063-6394a90ab18a 2024-02-14 Warnings Exact identifier application number: M013 PANADOL ACETAMINOPHEN Haleon US Holdings LLC e1799765-c247-42b4-ad6a-8ba7d136abf2 2024-02-06 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC f626ab17-01c9-4493-ba9e-0c8c11146384 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra ACETAMINOPHEN AND CAFFEINE Haleon US Holdings LLC e5c2d88a-d903-4ca0-b895-f27e791dfc4e 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC 9d384e88-5c11-4600-ac6c-a38371570138 2024-02-06 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