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

Additional Listing Data#

Finished product
Yes
Brand name base
TexaClear Kids Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/30mL
PYRILAMINE MALEATE25 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii69QQ58998Y, R35D29L3ZA
Rxcui1808189

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-925-08TexaClear Kids Allergy237 mL in 1 BOTTLELIQUID2379

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-925TEXACLEAR KIDS ALLERGY (CHLOPHEDIANOL HCL PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20241009_3b8a686f-d8e8-56db-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808189chlophedianol HCl 12.5 MG / pyrilamine maleate 25 MG in 30 mL Oral SolutionPSN3b8a686f-d8e8-56db-e054-00144ff8d46c9
1808189chlophedianol hydrochloride 0.417 MG/ML / pyrilamine maleate 0.833 MG/ML Oral SolutionSCD3b8a686f-d8e8-56db-e054-00144ff8d46c9
1808189chlophedianol HCl 12.5 MG / pyrilamine maleate 25 MG per 30 ML Oral SolutionSY3b8a686f-d8e8-56db-e054-00144ff8d46c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-925-0858809092508237 mL in 1 BOTTLE (58809-925-08) 237 ml2016-06-150000-00-00NoNoCurrent