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
Ingredient	Strength
CHLOPHEDIANOL HYDROCHLORIDE	25 mg/30mL
PYRILAMINE MALEATE	50 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69QQ58998Y	Internal UNII lookup
R35D29L3ZA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
17a2f643-fa98-21ee-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58809-360-08	Texaclear Fast Acting Allergy Relief	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLOPHEDIANOL HYDROCHLORIDE	ACTIVE INGREDIENT	69QQ58998Y	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
PYRILAMINE MALEATE	ACTIVE INGREDIENT	R35D29L3ZA	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
CHLOPHEDIANOL	ACTIVE MOIETY	42C50P12AP	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
PYRILAMINE	ACTIVE MOIETY	HPE317O9TL	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-360	TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC]	9	Current NDC, Legacy NDC, 1 package rows	20241009_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 168 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	62f7fcb9-e31a-4634-b1c2-44a9567e3a61	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Caplets	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	8e22f6bc-33ce-4bb0-99be-7947aa21f60e	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Severe Cold and Flu Syrup	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Haleon US Holdings LLC	777d2ac7-e3cc-4513-8b6f-b90b2ff2c672	2024-03-07	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	4c6025ff-4982-4408-b077-75dd5f5b65b2	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	423fd5e6-5d90-4539-81e0-0ae23881ee3a	2024-03-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	917df706-1982-4240-9f56-42d426b76cc5	2024-03-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	21a29998-29d6-4a36-a370-291d23bfb197	2024-03-05	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Care One (Retail Business Services, LLC.)	3c7ef3cf-f7f9-42bc-bf20-e36954b9671f	2024-03-05	Warnings	Exact identifier application number: M012
QUALITY CHOICE NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	da06e994-6848-4c1e-9432-31de5e626ea4	2024-03-02	Warnings	Exact identifier application number: M012
QUALITY CHOICE DayTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	417c4fa9-6458-40d0-b22a-2415194e250f	2024-03-02	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Aurohealth LLC	8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2	2024-03-01	Warnings	Exact identifier application number: M012
APRODINE	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	A-S Medication Solutions	bbc268b8-fa66-4dc5-b935-f77ae39d28c8	2024-02-29	Warnings	Exact identifier application number: M012
XtraCare Vaporizing Chest Rub	CAMPHOR, MENTHOL	Rejoice International	c3e220d6-fff4-452f-99a9-bd701fc608a0	2024-02-28	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	ebbb2f4b-ba84-40ad-96f6-60225119a33b	2024-02-27	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	1c93c45d-1141-4599-83ba-6d3b38f9ffc4	2024-02-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	3dc293c9-736b-4bd8-b993-ff83b9909bcd	2024-02-23	Warnings	Exact identifier application number: M012
Childrens Dibromm Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health (Leader) 70000	10cc7d67-30c4-4451-bf74-78abae3c8e25	2024-02-23	Warnings	Exact identifier application number: M012
Nasal Spray, 24-7 for Life	OXYMETAZOLINE HYDROCHLORIDE 0.05%	Lil' Drug Store Products, Inc.	11d27c75-fd95-f9da-e063-6394a90ac6b0	2024-02-20	Warnings	Exact identifier application number: M012
Nighttime Cold and Cough childrens	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	11652e8a-2242-4449-8a41-a8e75509025e	2024-02-20	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE
R35D29L3ZA	PYRILAMINE MALEATE	59-33-6	PYRILAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2672917	chlophedianol HCl 25 MG / pyrilamine maleate 50 MG in 30 mL Oral Solution	PSN	17a2f643-fa98-21ee-e054-00144ff88e88	12
2672917	chlophedianol hydrochloride 0.833 MG/ML / pyrilamine maleate 1.67 MG/ML Oral Solution	SCD	17a2f643-fa98-21ee-e054-00144ff88e88	12
2672917	chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 25 MG per 15 ML Oral Solution	SY	17a2f643-fa98-21ee-e054-00144ff88e88	12
2672917	chlophedianol hydrochloride 25 MG / pyrilamine maleate 50 MG per 30 ML Oral Solution	SY	17a2f643-fa98-21ee-e054-00144ff88e88	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58809-360-08	58809036008	237 mL in 1 BOTTLE, PLASTIC (58809-360-08)	237 ml	2014-10-21	0000-00-00	No	No	Current