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 94 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	17640528-c1f7-4881-ba86-bb3f488a952c	2025-10-24	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	33e259d6-b065-a677-e063-6394a90ab314	2025-10-23	Warnings	Exact identifier application number: M012
Severe Nighttime Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	1ec3fc79-4f38-439f-99be-646b82231aa5	2025-10-23	Warnings	Exact identifier application number: M012
Rycontuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories, Inc	41afb883-1158-9764-e063-6294a90a1712	2025-10-21	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE	CVS Pharmacy, Inc	1532ee21-e114-ded7-e063-6294a90ab025	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Method Pharmaceuticals	1538bf63-d020-3ba2-e063-6294a90aecc5	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Method Pharmaceuticals	389230e5-775e-5b0d-e054-00144ff88e88	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Method Pharmaceuticals, LLC	1539c3d4-d982-7d4e-e063-6394a90ad7d6	2025-10-21	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Method Pharmaceuticals, LLC	312ce620-4841-7488-e054-00144ff88e88	2025-10-21	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	5a60c923-8bb7-427f-9636-08ed5474f71b	2025-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	97ed70a0-b692-4c12-90d6-72b3c87e554c	2025-10-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	311e2b6b-21cb-4b4c-a78d-a0732d29602f	2025-10-21	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	13910ea1-37dd-43bb-9fe8-e843f59201b7	2025-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Amerisource Bergen	d6f185b6-8538-4eac-98da-83760c34b488	2025-10-20	Warnings	Exact identifier application number: M012
Quantum Health Bing Cherry Flavor	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	94d40c95-fa2b-42cf-b9f5-a5027d86401d	2025-10-20	Warnings	Exact identifier application number: M012
Quantum Health Meyer Lemon and Honey Flavor	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	fe780067-5a20-4d55-a108-91237cd9e5f4	2025-10-20	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	4157e680-37ac-eb4c-e063-6394a90a2a99	2025-10-17	Warnings	Exact identifier application number: M012
Norel AD	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL	U.S. PHARMACEUTICAL CORPORATION	53d9ed3c-212d-4b12-ac35-8bd49382b49d	2025-10-17	Warnings	Exact identifier application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	92c570ff-139f-49ff-a7bd-8a540ecc07c7	2025-10-17	Warnings	Exact identifier application number: M012
NoHist DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Larken Laboratories, Inc.	6aafe912-28ff-442f-8e07-b3c5993ac943	2025-10-16	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