Topcare Nasal

Product NDC: 36800-907
11-digit product format: 368000907
Labeler code: 36800
Product ID: 36800-907_fc76c4ee-54de-4f9a-a9a9-95563e4426fd
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline hydrochloride
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Topco Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-07-14
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: Topcare Nasal
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
f1dd78e0-f700-4469-85d6-18cc299e8746	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-907-10	Topcare Nasal	1 in 1 CARTON	SPRAY, METERED	1		5
36800-907-10	Topcare Nasal	30 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-907	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240906_f1dd78e0-f700-4469-85d6-18cc299e8746.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 116 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	37a88914-6234-4191-86f5-103c396c52af	2025-05-20	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	1ea15426-4f3d-4a97-a590-6bd73bc6cbcd	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	3833e781-f6ee-4c6d-8756-d8ea2293a1f2	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d45e99e5-ce66-4458-8d23-63a5dc7ae509	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choicel Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	460f0cc1-6a85-4d79-af87-a94fd151769e	2025-05-19	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	812a093f-cf83-4f7a-927a-1b5695be7f90	2025-05-19	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	SDA Laboratories, Inc.	1fd16b06-0c3e-4a30-ae6a-7b1632189c20	2025-05-16	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	79a6b8c7-0e81-4a46-a854-31f449042709	2025-05-16	Warnings	Exact identifier application number: M012
Tussin DM Sugar free	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	3a521b65-fb35-4cc3-b826-88513afda0f9	2025-05-16	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	51c7628a-c7cf-498f-8fb1-db732e2b8b6e	2025-05-16	Warnings	Exact identifier application number: M012
BACTIMICINA CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	DLC Laboratories, Inc.	eaf554d4-a758-4ed6-bec5-d6cbfedae408	2025-05-15	Warnings	Exact identifier application number: M012
Bactimicina Childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	DLC Laboratories, Inc.	d407a583-07ae-4d47-b15a-24b5865c82da	2025-05-15	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	RB Health (US) LLC	35322238-d498-1a52-e063-6394a90ac9c4	2025-05-15	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	a1405038-80f2-45e5-bd8c-8c6b0ee348be	2025-05-15	Warnings	Exact identifier application number: M012
Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	b919f0fe-fae0-4bd8-9ccd-d7569b2a7070	2025-05-13	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	2025-05-13	Warnings	Exact identifier application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	77be57fb-0ae5-4fad-97f3-b6a4b57383a9	2025-05-13	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	c948e612-a491-4ad0-adb9-cf31ef76e4d8	2025-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	c3d0b70f-d213-4e38-88ab-1c89d93a391d	2025-05-10	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Safeway, Inc.	c639a36d-c683-4a4d-90b7-eadec7464aa2	2025-05-08	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	f1dd78e0-f700-4469-85d6-18cc299e8746	5
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	f1dd78e0-f700-4469-85d6-18cc299e8746	5
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	f1dd78e0-f700-4469-85d6-18cc299e8746	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-907-10	36800090710	1 BOTTLE, SPRAY in 1 CARTON (36800-907-10) / 30 mL in 1 BOTTLE, SPRAY	2016-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Nasal Spray Drug Facts	Topco Associates LLC	2024-08-28	HUMAN OTC DRUG LABEL	5