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 128 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussnex FM Severe cough and congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	387df403-7803-4031-915e-8de9b103a162	2024-12-19	Warnings	Exact identifier application number: M012
Maximum strength Tussnex FM DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Guardian Drug Company	0bae53e3-9661-4bc6-9fcc-da7fa131b034	2024-12-19	Warnings	Exact identifier application number: M012
Vicks Vaposteam Lavender	CAMPHOR, (-)-	Kaz USA, Inc	03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9	2024-12-19	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Reese Pharmaceutical Co	6046dc50-f162-4e2d-aa3c-7d27efad477d	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	f94ae469-4c79-4ce9-9a3d-3bdc645be6d9	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	1c33a01f-1186-4a19-b639-a9cd49245220	2024-12-18	Warnings	Exact identifier application number: M012
HealthMart Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c	2024-12-18	Warnings	Exact identifier application number: M012
DG Health Immediate Release Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	f60a9d1b-7a63-43d3-b843-e1f31cf78873	2024-12-18	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80cad8d-da4c-049d-e053-2a95a90ac20e	2024-12-18	Warnings	Exact identifier application number: M012
Afrin Original	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	8a97c012-6a47-4607-9389-58a4eed17b08	2024-12-18	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Orazen Inc	ecddaa3b-e18f-1c74-e053-2995a90ad86a	2024-12-18	Warnings	Exact identifier application number: M012
Rite Aid Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Rite Aid	dfedbef1-8062-432d-e053-2a95a90a09e9	2024-12-18	Warnings	Exact identifier application number: M012
TheraCare Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	f7801843-f96c-710e-e053-6294a90a5086	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief G450	GUAIFENESIN	Rugby Laboratories	a6aa8cbd-21ff-4f84-b338-c05c2d46e6df	2024-12-18	Warnings	Exact identifier application number: M012
Refenesen Mucus Relief	GUAIFENESIN	Reese Pharmaceutical Co	861dffb7-8bf4-4f03-bcc2-ed8a35bc341d	2024-12-18	Warnings	Exact identifier application number: M012
Marcs Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Marc Glassman Inc	be3ad54f-522c-440d-b8c7-9664f6015566	2024-12-18	Warnings	Exact identifier application number: M012
Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee	2024-12-18	Warnings	Exact identifier application number: M012
Family Wellness Chest Congestion Relief	GUAIFENESIN	Family Dollar Services Inc	412f3459-4c22-4822-86bd-011fc3e91ca6	2024-12-18	Warnings	Exact identifier application number: M012
Marcs Mucus Relief	GUAIFENESIN	Marc Glassman Inc	455b9f01-206c-4534-a006-292d2bd48f47	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief G450	GUAIFENESIN	Cardinal Health	4586a83f-077c-4fb3-adfe-7a9497a78d97	2024-12-18	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