Nostrilla

Product NDC: 63736-730
11-digit product format: 637360730
Labeler code: 63736
Product ID: 63736-730_5ab00067-efa6-fc48-e063-6294a90a6499
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline Hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Insight Pharmaceuticals LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-08
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .05 mg/100mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63736-730	63736-730-02	D	Discontinued by firm		2026-10-23

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: Nostrilla
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.05 mg/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup
1001058	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
86217847-8e2b-48cc-b289-4987fd3aa7c3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63736-730-01	2020-04-10	Nostrilla
63736-730-01	2020-04-10	Nostrilla
63736-730-02	2020-04-10	Nostrilla
63736-730-02	2020-04-10	Nostrilla
63736-730-01	2020-01-31	Nostrilla
63736-730-01	2020-01-31	Nostrilla
63736-730-02	2020-01-31	Nostrilla
63736-730-02	2020-01-31	Nostrilla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63736-730-01	Nostrilla	1 in 1 CARTON	SPRAY, METERED	1	7
63736-730-01	Nostrilla	15 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	15	7
63736-730-02	Nostrilla	22.5 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	22.5	7
63736-730-02	Nostrilla	1 in 1 CARTON	SPRAY, METERED	1	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Oxymetazoline Hydrochloride	ACTIVE INGREDIENT	K89MJ0S5VY	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2
Oxymetazoline	ACTIVE MOIETY	8VLN5B44ZY	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2
glycine	INACTIVE INGREDIENT	TE7660XO1C	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2
water	INACTIVE INGREDIENT	059QF0KO0R	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-730	NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS LLC]	7	Current NDC, Legacy NDC, 4 package rows	20241113_86217847-8e2b-48cc-b289-4987fd3aa7c3.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 141 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.	Kenvue Brands LLC	f81d924e-10e9-0e9d-e053-6294a90a2ddf	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8b516736-86ac-47cb-a0ec-038d4c3a0020	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu plus Cough Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e85e5eb9-3ecf-4784-999e-111e38e306f5	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ef8a846d-4b29-4fd8-a683-fada04d0a2b9	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD Plus FLU	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	9761c807-75a1-4498-a8c6-1f2b1c9ffde6	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Mucus Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	24ac94e8-b223-424e-bcd2-9c027c8ff9ed	2024-11-07	Warnings	Exact identifier application number: M012
Primatene	EPHEDRINE HYDROCHLORIDE	Foundation Consumer Brands	2170f081-c03f-47e8-bc63-4052c5e653fa	2024-11-07	Warnings	Exact identifier application number: M012
Rompe Pecho Max Multi Symptoms	ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN	EFFICIENT LABORATORIES INC	938e4e47-d2d9-4b0d-bf88-e9f41b501945	2024-11-07	Warnings	Exact identifier application number: M012
topcare sinus nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	ca1fefed-e9d7-430a-9da4-972b1a6fb786	2024-11-07	Warnings	Exact identifier application number: M012
Leader Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	dd82a389-9ec5-4b3f-a9ea-1a56871ebd17	2024-11-07	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	1a8e2e03-e11b-4da1-945b-e2caadea7243	2024-11-07	Warnings	Exact identifier application number: M012
SUDOGEST NASAL DECONGESTANT	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	09feb5f0-c22d-4a1b-97a0-d5767e5f7730	2024-11-07	Warnings	Exact identifier application number: M012
up and up childrens allergy melts	DIPHENHYDRAMINE HCL	Target Corporation	f98d1d54-8e11-4bb1-825a-ab5447d37847	2024-11-07	Warnings	Exact identifier application number: M012
good sense severe day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	44130a1b-63cc-42ac-9590-fdf21a12d164	2024-11-07	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	a5ff1134-8985-4585-8e61-a5fd5f60afeb	2024-11-07	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	50528d29-ce8c-4efb-a86c-17246b017db0	2024-11-07	Warnings	Exact identifier application number: M012
cooling severe daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS Pharmacy	d4a21760-b2bd-4e26-bff0-6fc1b05d26b3	2024-11-07	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	60870311-3234-44ba-95dd-09cf4ea3d508	2024-11-07	Warnings	Exact identifier application number: M012
adult dm max cough and chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution Inc	3a6855c1-da6d-4fa9-81fe-d2e61355989f	2024-11-06	Warnings	Exact identifier application number: M012
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	e51dfb62-40d0-4bec-9574-90057cb35bcc	2024-11-06	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
1001058	Nostrilla 12 Hour 0.05 % Nasal Spray	PSN	86217847-8e2b-48cc-b289-4987fd3aa7c3	7
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	86217847-8e2b-48cc-b289-4987fd3aa7c3	7
1001058	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Nostrilla]	SBD	86217847-8e2b-48cc-b289-4987fd3aa7c3	7
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	86217847-8e2b-48cc-b289-4987fd3aa7c3	7
1001058	Nostrilla 0.05 % Nasal Spray	SY	86217847-8e2b-48cc-b289-4987fd3aa7c3	7
1001058	Nostrilla 0.5 MG/ML Nasal Spray	SY	86217847-8e2b-48cc-b289-4987fd3aa7c3	7
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	86217847-8e2b-48cc-b289-4987fd3aa7c3	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-730-01	63736073001	1 BOTTLE, SPRAY in 1 CARTON (63736-730-01) / 15 mL in 1 BOTTLE, SPRAY	2009-06-08	0000-00-00	No	No	Current
63736-730-02	63736073002	1 BOTTLE, SPRAY in 1 CARTON (63736-730-02) > 22.5 mL in 1 BOTTLE, SPRAY	2009-06-08	0000-00-00	No	No	Current