FDA.reportPublic FDA data

Texaclear Fast Acting Allergy Relief

Product NDC
58809-360
11-digit product format
588090360
Labeler code
58809
Product ID
58809-360_42b3cfc3-8903-edc1-e063-6394a90aa6fe
Type
HUMAN OTC DRUG
Nonproprietary name
Chlophedianol Hydrochloride, Pyrilamine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
GM Pharmaceuticals, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-21
Substance
CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength
25; 50 mg/30mL; mg/30mL
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 Fast Acting Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE25 mg/30mL
PYRILAMINE MALEATE50 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
69QQ58998YInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2672917Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
17a2f643-fa98-21ee-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-360-08Texaclear Fast Acting Allergy Relief237 mL in 1 BOTTLE, PLASTICLIQUID23712

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998YTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZATEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
CHLOPHEDIANOLACTIVE MOIETY42C50P12APTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
PYRILAMINEACTIVE MOIETYHPE317O9TLTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-360TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC]9Current NDC, Legacy NDC, 1 package rows20241009_17a2f643-fa98-21ee-e054-00144ff88e88.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 122 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLThe Kroger COf6da2e02-42c7-1ede-e053-6394a90aff5f2025-02-09WarningsExact identifier
application number: M012
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
application number: M012
Childrens Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC5d56ccd2-1c28-4750-9454-44809091ad2f2025-02-05WarningsExact identifier
application number: M012
SanaTos Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
application number: M012
SofSkin Vaporizing Chest Rub and Cough SuppressantCAMPHOR, MENTHOL, EUCALYPTUS OILViny Health and Beauty Inc34626cf5-64fc-15c0-e063-6294a90aa3102025-02-04WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY, INC17922df7-7867-4300-bd99-55aee7b606062025-02-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healthf4b8ff54-47b5-4d18-bf4e-b101abb22a242025-02-03WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf40bfdfc-1cb4-4604-9790-fb8d1d5173c62025-01-31WarningsExact identifier
application number: M012
NIGHTIME COLD AND FLUNIGHTIME COLD AND FLUTARGET CORP9dee9b92-eac9-b07d-e053-2995a90a06022025-01-31WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
application number: M012
BENADRYL AllergyDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC224ba2a3-1a93-29c8-e063-6394a90a9bef2025-01-30WarningsExact identifier
application number: M012
Extra Strength Nite-Time Pain Relief430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLETWALGREENSc25cff5a-93f5-62aa-e053-2a95a90aa7b42025-01-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALGREENSdbf5c814-4e69-13ac-e053-2a95a90a49a32025-01-30WarningsExact identifier
application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWALGREENSf3770976-de73-52b8-e053-2995a90aad4f2025-01-30WarningsExact identifier
application number: M012
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26c82bc3-5753-4d56-96a4-a3f9c8c267d02025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8095b211-8ae7-44e5-b89a-b7f730e28d512025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2cf2f35b-5d59-e3ff-e063-6294a90a9b452025-01-30WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c52025-01-30WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672917chlophedianol HCl 25 MG / pyrilamine maleate 50 MG in 30 mL Oral SolutionPSN17a2f643-fa98-21ee-e054-00144ff88e8812
2672917chlophedianol hydrochloride 0.833 MG/ML / pyrilamine maleate 1.67 MG/ML Oral SolutionSCD17a2f643-fa98-21ee-e054-00144ff88e8812
2672917chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 25 MG per 15 ML Oral SolutionSY17a2f643-fa98-21ee-e054-00144ff88e8812
2672917chlophedianol hydrochloride 25 MG / pyrilamine maleate 50 MG per 30 ML Oral SolutionSY17a2f643-fa98-21ee-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-360-0858809036008237 mL in 1 BOTTLE, PLASTIC (58809-360-08) 237 ml2014-10-210000-00-00NoNoCurrent