Topcare Nasal

Product NDC: 36800-388
11-digit product format: 368000388
Labeler code: 36800
Product ID: 36800-388_e8544cb0-cf27-4fa0-809b-a156bf589aee
Type: HUMAN OTC DRUG
Nonproprietary name: Oxymetazoline HCl
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Topco Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-11-26
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
b5434599-5485-4949-9d76-b1ef3ad17c1a	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
36800-388-10	Topcare Nasal	30 mL in 1 BOTTLE, PUMP	SPRAY, METERED	30		5
36800-388-10	Topcare Nasal	1 in 1 CARTON	SPRAY, METERED	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-388-10	ML - Milliliter	36800-388	47c0eedb-9609-4ca8-a1ed-b4a0dd825e3b	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-388	TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [TOPCO ASSOCIATES LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240906_b5434599-5485-4949-9d76-b1ef3ad17c1a.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 150 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	838d2f11-2ee4-4081-98c8-b87e79aa47c4	2024-10-11	Warnings	Exact identifier application number: M012
Menthol	COUGH SUPPRESSANT	McKesson	9d4def70-480f-f2fa-e053-2995a90a9877	2024-10-10	Warnings	Exact identifier application number: M012
Menthol	COUGH SUPPRESSANT	McKesson	9d5b4ef6-4eb8-41f6-e053-2a95a90a1350	2024-10-10	Warnings	Exact identifier application number: M012
Tukol Sugar Free Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Genomma Lab USA	95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841	2024-10-08	Warnings	Exact identifier application number: M012
Rompe Pecho CF CF	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06e96e0c-f21f-e706-e063-6294a90a0780	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	United Natural Foods, Inc.	f9f0d020-e031-245e-e053-6294a90addb5	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	United Natural Foods, Inc.	fb7ee463-8003-a306-e053-6294a90a8259	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	United Natural Foods, Inc.	fb7e4a84-d2c2-65e5-e053-6394a90a0c72	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	CHERRY	United Natural Foods, Inc.	f9f0e853-6997-a49b-e053-6294a90aa4b8	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	United Natural Foods, Inc.	fb7fa728-911d-aaf0-e053-6394a90ace31	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	United Natural Foods, Inc.	fb7f3b84-1e61-eadf-e053-6394a90a9e5c	2024-10-08	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	United Natural Foods, Inc.	fb7f515f-7302-d153-e053-6394a90a0834	2024-10-08	Warnings	Exact identifier application number: M012
Rompe Pecho NT NT	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Efficient Laboratories Inc	06faafaa-50a6-c16e-e063-6294a90a49cb	2024-10-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough and Congestion DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Bryant Ranch Prepack	8c25285e-e2cd-4e10-af63-5dce8098b615	2024-10-08	Warnings	Exact identifier application number: M012
Severe Throat Sore Drops	MENTHOL	Target Corporation Inc.	949543d5-5043-ac06-e053-2995a90ab398	2024-10-07	Warnings	Exact identifier application number: M012
Natural Herbal Cough Drops	COUGH DROPS	Target Corporation Inc.	a23ddfa9-19e0-99ee-e053-2a95a90a6856	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	SIMPLY MENTHOL COUGH DROPS	Perrigo Direct, Inc.	fb809c63-94f1-bb7a-e053-6294a90a0a39	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	SIMPLY CHERRY COUGH DROPS	Perrigo Direct, Inc.	fb808dc5-bf63-836c-e053-6294a90a80aa	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	SIMPLY HONEY LEMON	Perrigo Direct Inc.	fb898616-d604-b4c3-e053-6294a90a23bf	2024-10-07	Warnings	Exact identifier application number: M012
Natural Herb Cough Drops	MENTHOL HERB	CVS Pharmacy	fcd16063-abca-49a0-e053-6294a90acb26	2024-10-07	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	b5434599-5485-4949-9d76-b1ef3ad17c1a	5
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	b5434599-5485-4949-9d76-b1ef3ad17c1a	5
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	b5434599-5485-4949-9d76-b1ef3ad17c1a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-388-10	36800038810	1 BOTTLE, PUMP in 1 CARTON (36800-388-10) / 30 mL in 1 BOTTLE, PUMP	2002-11-26	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