Giltuss Severe Sinus

Product NDC: 58552-142
11-digit product format: 585520142
Labeler code: 58552
Product ID: 58552-142_40b8f0e4-90a0-f6b2-e063-6394a90a083b
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline HCl
Dosage form: SPRAY
Route: NASAL
Labeler: Gil Pharmaceutical Corp
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-07-28
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 g/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [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: Giltuss Severe Sinus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	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
ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-01-31	Giltuss Severe Sinus Nasal Spray
2022-01-31	Giltuss Severe Sinus Nasal Spray
2022-01-28	Giltuss Severe Sinus Nasal Spray
2022-01-28	Giltuss Severe Sinus Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58552-142-15	Giltuss Severe Sinus	1 in 1 CARTON	SPRAY	1		6
58552-142-15	Giltuss Severe Sinus	15 mL in 1 BOTTLE, SPRAY	SPRAY	15		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58552-142-15	ML - Milliliter	58552-142	3cbe8963-a575-45bf-98a0-e85fd6974b70	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58552-142	GILTUSS SEVERE SINUS (OXYMETAZOLINE HCL) SPRAY [GIL PHARMACEUTICAL CORP]	5	Current NDC, Legacy NDC, 2 package rows	20241027_ab7fae3b-1f7d-5d0f-e053-2a95a90a148e.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 139 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUDAFED PE Head Congestion Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	1e528f78-0ced-4a06-935a-84056c921727	2024-11-08	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	657a1e59-104c-4152-b2c9-00a8b82dc78e	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	47c61858-72ce-409b-a3af-a63620cf7d13	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Benadryl Allergy Plus Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	b8b75904-3806-4258-89c1-d6ff486ed41c	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	464de5de-0e7a-41d6-875f-dd0e5fe7893c	2024-11-08	Warnings	Exact identifier application number: M012
McKesson Phenylephrine HCl	PHENYLEPHRINE HCL	McKesson Medical-Surgical	e09060f7-ca0b-5f7c-e053-2995a90ab344	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e0e216ef-300c-4f57-87e6-62a5327e09b4	2024-11-08	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	969c0718-ba6e-4edb-9f55-43bc9500450f	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	62a70d9a-4e78-497c-8f75-012ab94e92f6	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Publix Super Markets Inc	25b2ad8a-5835-4496-815f-73a7fb40dcfd	2024-11-08	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	296f20c0-8b5f-4a08-9329-f93c92e63867	2024-11-08	Warnings	Exact identifier application number: M012
topcare tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Topco Associates LLC	d3cae69e-41a5-4099-a3f4-ce25fd94df73	2024-11-08	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	9d147d1e-8ea5-4e0f-8ae8-1da16f119496	2024-11-08	Warnings	Exact identifier application number: M012
equate adult cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	WALMART INC.	e770bdb2-3662-4538-8199-fe4a4059c720	2024-11-08	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	23dcb627-c867-435f-9d1a-a9f49e58b58f	2024-11-08	Warnings	Exact identifier application number: M012
good neighbor pharmacy adult tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	ced71993-f535-4e28-bc1d-3fcb7d86e9b7	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy	2f1dc8f8-79c5-4724-99aa-a55330ed9d5f	2024-11-08	Warnings	Exact identifier application number: M012
good sense day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	4ac6b64a-8214-4b03-8aa5-0d3199cf0b72	2024-11-08	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	1dd9afb6-9b58-4274-a557-900a0cb23524	2024-11-08	Warnings	Exact identifier application number: M012
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	6
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	6
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58552-142-15	58552014215	1 BOTTLE, SPRAY in 1 CARTON (58552-142-15) / 15 mL in 1 BOTTLE, SPRAY	2020-07-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Giltuss Severe Sinus Nasal Spray	Gil Pharmaceutical Corp \| SEAWAY PHARMA	2025-10-09	HUMAN OTC DRUG LABEL	6