Gilphex

Product NDC: 58552-336
11-digit product format: 585520336
Labeler code: 58552
Product ID: 58552-336_40b9f8d7-5f71-656f-e063-6294a90a3b8b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Gil Pharmaceutical Corp.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-05
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 390; 10 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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: Gilphex
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	390 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2603663	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
e7c8fb97-02cf-4df6-b477-9ff69d6b675d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58552-336-01	Gilphex	100 in 1 BOTTLE	TABLET	100		5
58552-336-02	Gilphex	2 in 1 BLISTER PACK	TABLET	2		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-336-01	EA - Each	58552-336	8ae47051-d076-4783-a98d-35f5b573910e	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-336	GILPHEX (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP.]	4	Current NDC, Legacy NDC, 2 package rows	20241027_e7c8fb97-02cf-4df6-b477-9ff69d6b675d.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 99 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freegells Cough Drops Menthol Honey Lemon 80ct	MENTHOL	R.L. ALBERT & SON, INC	61deea94-d0a9-4563-926b-53f255a7c425	2025-10-08	Warnings	Exact identifier application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS	MENTHOL	R.L. ALBERT & SON, INC	c6b36350-386b-4346-bef0-a37ec11319c0	2025-10-08	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	3314b174-d5bb-4843-9288-9b9c5fce79d5	2025-10-08	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	407b7cbb-7ebd-7b7e-e063-6394a90af501	2025-10-06	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc	2025-10-06	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	2b19fdd2-8088-47f2-be20-f220a6b825fc	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	40802fb6-c1ec-d7b0-e063-6394a90ab423	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Diabetic	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	3f64c81a-bbfc-4575-e063-6294a90a6ed7	2025-10-06	Warnings	Exact identifier application number: M012
TexaClear Severe Cough, Cold and Flu	CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GM Pharmaceuticals, INC	cb99e5b3-1908-43c9-b31f-d35e7ce58b44	2025-10-06	Warnings	Exact identifier application number: M012
RoboHBr Cough SUPPRESSANT	DEXTROMETHORPHAN HBR	DXM Pharmaceutical, Inc	0af624ce-191f-45e1-882b-e8acb90cc77b	2025-10-06	Warnings	Exact identifier application number: M012
RoboTablets	DEXTROMETHORPHAN	DXM Pharmaceutical, Inc	b92cf698-032d-4d8d-b19c-456c6338b094	2025-10-06	Warnings	Exact identifier application number: M012
SinuLief	LORATADINE	RoseWell Pharmaceuticals LLC	32619143-a782-3497-e063-6394a90aaaec	2025-10-06	Warnings	Exact identifier application number: M012
STAHIST AD	CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Magna Pharmaceuticals, Inc.	ccedbc38-2479-4c35-9f86-a9f29bcfab3f	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear 8	PYRILAMINE MALEATE	GM Pharmaceuticals, INC	8e524967-d01c-4c93-9198-c42f15fe3fe0	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear PD	TRIPROLIDINE HYDROCHLORIDE	GM Pharmaceuticals, INC	f3ede5b7-1b0f-493a-b647-4459affc7e54	2025-10-03	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	InvaTech Pharma Solutions LLC	40288ecf-043d-eb9e-e063-6394a90ac0a7	2025-10-02	Warnings	Exact identifier application number: M012
Guaifenesin 400	GUAIFENESIN TABLETS 400	InvaTech Pharma Solutions LLC	40291505-55ca-0759-e063-6394a90acee1	2025-10-02		Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3dd5b783-5b64-24b5-e063-6394a90ab4ee	2025-10-02	Warnings	Exact identifier application number: M012
Acetaminophen and Diphenhydramine citrate	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	InvaTech Pharma Solutions LLC	403a88fa-e06b-9b6e-e063-6394a90a97b8	2025-10-02	Warnings	Exact identifier application number: M012
Equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	United Natural Foods, Inc. dba UNFI	3053f6d7-0eff-488c-8901-770dcc62af06	2025-10-02	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2603663	guaiFENesin 390 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	e7c8fb97-02cf-4df6-b477-9ff69d6b675d	5
2603663	guaifenesin 390 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	e7c8fb97-02cf-4df6-b477-9ff69d6b675d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-336-01	58552033601	100 TABLET in 1 BOTTLE (58552-336-01)	100 tablet	2022-05-05	0000-00-00	No	No	Current
58552-336-02	58552033602	2 TABLET in 1 BLISTER PACK (58552-336-02)	2 tablet	2022-05-05	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gilphex	Gil Pharmaceutical Corp. \| Syntho Pharmaceuticals, Inc.	2025-10-09	HUMAN OTC DRUG LABEL	5