Giltuss Cough and Cold

Product NDC: 58552-331
11-digit product format: 585520331
Labeler code: 58552
Product ID: 58552-331_5746a790-450c-79d7-e063-6394a90a7077
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Gil Pharmaceutical Corp
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-01
Marketing end: 2027-01-30
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 388; 28; 10 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
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: Giltuss Cough and Cold

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	388 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	28 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
9D2RTI9KYH	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
2167784	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
8590fcc9-c0dd-f43b-e053-2991aa0a692e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58552-331-20	Giltuss Cough and Cold	2 in 1 CARTON	TABLET	2		7
58552-331-20	Giltuss Cough and Cold	10 in 1 BLISTER PACK	TABLET	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-331-20	EA - Each	58552-331	d108afdb-aecd-4da1-97e1-bd810c74905c	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-331	GILTUSS COUGH AND COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP]	6	Current NDC, Legacy NDC, 2 package rows	20250315_8590fcc9-c0dd-f43b-e053-2991aa0a692e.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 147 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sinus pressure and pain pe	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a7931e4c-8a5e-66e2-e053-2995a90af2a4	2024-10-18	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	570ea130-6a99-446e-9f97-14fc95809006	2024-10-18	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a14999e3-a9d9-0a1f-e053-2995a90af7b3	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a793000b-3ef9-5662-e053-2a95a90ad0da	2024-10-18	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime and Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	37455f86-ab21-472b-9e80-40324699f3ca	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3396a27-8643-71fa-e053-2a95a90a713d	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3397f69-3267-ca0b-e053-2995a90a7db5	2024-10-18	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	747512a2-3b6d-496b-ab80-819060314163	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	9daf7f40-d9c5-4367-be41-894208358fc1	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	608e6808-29e4-40bc-8496-24c092681a1b	2024-10-18	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	665db127-ee04-46c4-bff0-e0fe9950c3e2	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8	2024-10-18	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	604d7e53-4bfd-4cdd-aed2-b304ae82ce44	2024-10-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	4d93a703-c905-4fb3-b772-11c207065d4d	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	62c35320-87b5-46e2-9f6f-cb0882bdb52e	2024-10-17	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dcf6cf-373c-ea83-e053-2a95a90ae57a	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5918-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5916-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
ALLERGY MULTISYMPTOM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e9ab8e-2252-180d-e053-2a95a90a788f	2024-10-17	Warnings	Exact identifier application number: M012
COLD PLUS HEAD CONGESTION SEVERE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	3430c7e4-e142-407e-bed5-358dd6bd10f7	2024-10-17	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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2167784	dextromethorphan HBr 28 MG / guaiFENesin 388 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	8590fcc9-c0dd-f43b-e053-2991aa0a692e	7
2167784	dextromethorphan hydrobromide 28 MG / guaifenesin 388 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	8590fcc9-c0dd-f43b-e053-2991aa0a692e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-331-20	58552033120	2 BLISTER PACK in 1 CARTON (58552-331-20) / 10 TABLET in 1 BLISTER PACK	2 blister pack	2021-04-01	2027-01-30	No	No	Current