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 49 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	97554f40-f9aa-4dbf-a6f2-de6197236ab4	2026-02-25	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Family Dollar Stores, Inc	1b50b865-3dfc-4b3f-86d5-5e91ca772445	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Vaproizing	CAMPHOR	H E B	577fda09-588a-4c2e-ada5-eeda32d1aabe	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	Major Pharmaceuticals	11416620-4892-44ba-9780-db27efff6743	2026-02-24	Warnings	Exact identifier application number: M012
Family Wellness SF Honey Lemon Cough Drops	MENTHOL	Family Dollar	4437853d-1f42-a41d-e063-6294a90aa81e	2026-02-24	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	64a93715-e7b1-4de1-8099-8ad6c585d517	2026-02-24	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	86af74c2-9183-4ee9-ad1e-d88dfc8bf47d	2026-02-24	Warnings	Exact identifier application number: M012
Cough DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	39adf23e-76f3-42e1-a9f4-55feb38078e5	2026-02-24	Warnings	Exact identifier application number: M012
Revasol Tussin DM Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Rnv LLC	4b7fd320-2f39-fa1a-e063-6294a90ada9e	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	47317865-4310-4f07-8815-f3130963307d	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Brands	42720fa0-fcdd-4614-80b2-16d0ada345b1	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	cc09a8c5-d173-4261-b838-96e6a16e2ff9	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	96a1055f-e831-4f4b-8af3-7a41838c194c	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Brands	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	2026-02-23	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Better Living Brands, LLC	0948648c-1c5f-4225-a754-120ca8859f19	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Tussin	GUAIFENESIN	Rnv LLC	f66dc593-9023-40e8-9cc3-0380b04b4305	2026-02-23	Warnings	Exact identifier application number: M012
Equate Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	3006971b-784c-43fd-91a6-d96876bbf185	2026-02-23	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	04e70311-6412-4a20-84e3-f6e26d5f19ab	2026-02-20	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	7f2b72cc-d4f7-431f-be61-c103cf8c489e	2026-02-20	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	dca04d80-e781-40b1-e053-2995a90a7010	2026-02-20	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