Giltuss Allergy Plus

Product NDC: 58552-334
11-digit product format: 585520334
Labeler code: 58552
Product ID: 58552-334_5746a65e-86da-77cd-e063-6394a90aefc7
Type: HUMAN OTC DRUG
Nonproprietary name: Chlophedianol HCl, Chlorpheniramine maleate, 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: 2027-06-30
Substance: PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE
Active strength: 10; 3.5; 24 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Allergy Plus

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1
CHLORPHENIRAMINE MALEATE	3.5 mg/1
CHLOPHEDIANOL HYDROCHLORIDE	24 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
V1Q0O9OJ9Z	Internal UNII lookup
69QQ58998Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1424872	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
85a0dc7f-ffb5-7d52-e053-2991aa0a602a	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
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
58552-334-20	Giltuss Allergy Plus	10 in 1 BOX	TABLET	10		7
58552-334-20	Giltuss Allergy Plus	2 in 1 POUCH	TABLET	2		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-334-20	EA - Each	58552-334	0bd033eb-0685-492e-bc5d-585aed9a613c	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-334	GILTUSS ALLERGY PLUS (CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP]	6	Current NDC, Legacy NDC, 2 package rows	20250315_85a0dc7f-ffb5-7d52-e053-2991aa0a602a.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 134 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	508a65ee-42fa-4c0b-b24d-9faac6b0eba7	2024-11-24	Warnings	Exact identifier application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	cb68eef0-b027-4bf1-b78f-f31844a8c06c	2024-11-22	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	de2a64ce-c169-4162-b79e-d3809bea2147	2024-11-22	Warnings	Exact identifier application number: M012
12 Hour Nasal Decongestant Extra Moisturizing	NASAL SPRAY	WinCo Foods LLC	13fbde45-958c-455f-b766-f6a34342ee95	2024-11-21	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a01abac3-c13e-40f2-ae98-34bd6c9b7504	2024-11-21	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6	2024-11-21	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	028b025e-2dde-4bef-ba7b-61774e855b4b	2024-11-21	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	856cb3c3-8f32-4285-8c13-25f01779a31a	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	3375a059-2939-438e-92b5-a7f1952bbb22	2024-11-21	Warnings	Exact identifier application number: M012
NiteTime Cold/Flu, Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	9033bf94-f444-4488-b717-050d04dee388	2024-11-21	Warnings	Exact identifier application number: M012
Day and Night Sinus Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	4b554ce8-9a6a-444f-b5ea-63359bbc0653	2024-11-21	Warnings	Exact identifier application number: M012
Day Severe Cold and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	7492b381-9eca-4b07-b356-63fdaea14f81	2024-11-21	Warnings	Exact identifier application number: M012
Severe sinus Congestion Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	e173bec9-14df-4535-a023-47d8cda8d4ec	2024-11-21	Warnings	Exact identifier application number: M012
COLD FLU and SORE THROAT RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	1161e5dc-0677-4fb9-964f-971a508098b6	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services, LLC	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2024-11-21	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	WinCo Foods LLC	b3b6065a-56da-45e9-b89d-f6553bc181c9	2024-11-21	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline Sinus Severe	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	13237d31-c60a-49f8-9b96-4414cf766a08	2024-11-21	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5b55d1df-275b-40d8-bde3-fc43313b7eb3	2024-11-20	Warnings	Exact identifier application number: M012
Halls Green Apple	MENTHOL	Mondelez Global LLC	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	2024-11-20	Warnings	Exact identifier application number: M012
Halls Blueberry	MENTHOL	Mondelez Global LLC	275a6935-ea44-486e-e063-6394a90ae19a	2024-11-20	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1424872	chlophedianol HCl 24 MG / chlorpheniramine maleate 3.5 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	85a0dc7f-ffb5-7d52-e053-2991aa0a602a	7
1424872	chlophedianol hydrochloride 24 MG / chlorpheniramine maleate 3.5 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	85a0dc7f-ffb5-7d52-e053-2991aa0a602a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-334-20	58552033420	10 POUCH in 1 BOX (58552-334-20) / 2 TABLET in 1 POUCH	10 pouch	2021-04-01	2027-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Giltuss Allergy Plus - Gil Pharmaceutical Corp	Gil Pharmaceutical Corp	2026-07-23	HUMAN OTC DRUG LABEL	8