Topcare Nasal

Product NDC: 36800-304
11-digit product format: 368000304
Labeler code: 36800
Product ID: 36800-304_44e042ee-c643-4058-9db8-00442eb010e3
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Topco Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1989-12-15
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

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	36800-304	36800-304-72	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
f2b2467f-2d9b-4742-b90a-95975c3b694f	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	SPL version
36800-304-10	Topcare Nasal	1 in 1 CARTON	SPRAY	1	9
36800-304-10	Topcare Nasal	30 mL in 1 BOTTLE, SPRAY	SPRAY	30	9
36800-304-72	Topcare Nasal	1 in 1 CARTON	SPRAY	1	9
36800-304-72	Topcare Nasal	37 mL in 1 BOTTLE, SPRAY	SPRAY	37	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-304-10	ML - Milliliter	36800-304	478ea9f1-bed9-4ac2-bb6a-87c3a84fc728	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-304	TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	8	Current NDC, Legacy NDC, 4 package rows	20240913_f2b2467f-2d9b-4742-b90a-95975c3b694f.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 101 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens PediaClear 8	PYRILAMINE MALEATE	GM Pharmaceuticals, INC	8e524967-d01c-4c93-9198-c42f15fe3fe0	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear PD	TRIPROLIDINE HYDROCHLORIDE	GM Pharmaceuticals, INC	f3ede5b7-1b0f-493a-b647-4459affc7e54	2025-10-03	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	InvaTech Pharma Solutions LLC	40288ecf-043d-eb9e-e063-6394a90ac0a7	2025-10-02	Warnings	Exact identifier application number: M012
Guaifenesin 400	GUAIFENESIN TABLETS 400	InvaTech Pharma Solutions LLC	40291505-55ca-0759-e063-6394a90acee1	2025-10-02		Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3dd5b783-5b64-24b5-e063-6394a90ab4ee	2025-10-02	Warnings	Exact identifier application number: M012
Acetaminophen and Diphenhydramine citrate	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	InvaTech Pharma Solutions LLC	403a88fa-e06b-9b6e-e063-6394a90a97b8	2025-10-02	Warnings	Exact identifier application number: M012
Equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	United Natural Foods, Inc. dba UNFI	3053f6d7-0eff-488c-8901-770dcc62af06	2025-10-02	Warnings	Exact identifier application number: M012
Rompe Pecho CF	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	401a97af-36ae-4e54-e063-6294a90ab3ee	2025-10-01	Warnings	Exact identifier application number: M012
NyQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	724d0889-5ba5-3125-e053-2a91aa0a92c1	2025-10-01	Warnings	Exact identifier application number: M012
DayQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	724f2833-34bd-6a9e-e053-2991aa0a073d	2025-10-01	Warnings	Exact identifier application number: M012
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	InvaTech Pharma Solutions LLC	b8d360fa-0d80-f6a8-e053-2a95a90a8bd4	2025-10-01		Exact identifier application number: M012
LEADER TUSSIN CF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	f4ffe87b-0a62-44ac-b84a-08cf77cda7f5	2025-10-01	Warnings	Exact identifier application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-Eleven	OXYMETAZOLINE HCL NASAL SOLUTION 0.05%	Lil' Drug Store Products, Inc.	3e781417-9ffc-f2c9-e063-6294a90a7205	2025-09-30	Warnings	Exact identifier application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf	2025-09-30	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3ff240ba-90b2-4c17-e063-6394a90ac56f	2025-09-29	Warnings	Exact identifier application number: M012
Dometuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	3fcace53-a81f-e774-e063-6294a90a32fa	2025-09-27	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	f6a3680a-3ac6-4fd4-be52-ce29064c4aa1	2025-09-26	Warnings	Exact identifier application number: M012
No Drip Severe Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5	2025-09-26	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa0b3be-2124-ed1d-e063-6294a90aaf48	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3fa17255-514f-db47-e063-6294a90ae454	2025-09-25	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	f2b2467f-2d9b-4742-b90a-95975c3b694f	9
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	f2b2467f-2d9b-4742-b90a-95975c3b694f	9
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	f2b2467f-2d9b-4742-b90a-95975c3b694f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-304-10	36800030410	1 BOTTLE, SPRAY in 1 CARTON (36800-304-10) / 30 mL in 1 BOTTLE, SPRAY	1989-12-15	0000-00-00	No	No	Current
36800-304-72	36800030472	1 BOTTLE, SPRAY in 1 CARTON (36800-304-72) > 37 mL in 1 BOTTLE, SPRAY	2009-03-17	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	2025-12-13	HUMAN OTC DRUG LABEL	9