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		2026-10-20

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 90 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
G-Supress DX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5dd44337-f3aa-4e73-a206-4a29850a2f7c	2025-11-12	Warnings	Exact identifier application number: M012
Allergy Relief Complete	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	15b3de6c-7ccc-408b-8789-d0e2f21a8835	2025-11-12	Warnings	Exact identifier application number: M012
PRESGEN PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE	KRAMER NOVIS	12fb91e5-6059-4b3a-a2de-762aa51a25b7	2025-11-12	Warnings	Exact identifier application number: M012
Sorbugen	DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE	Kramer Novis	a8f2a2d7-0360-45a8-9635-c852f4a7d7ba	2025-11-12	Warnings	Exact identifier application number: M012
DESGEN DM	DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL	Kramer Novis	6ab47174-e1fd-47ce-8788-06b7cdad5218	2025-11-12	Warnings	Exact identifier application number: M012
Presgen	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Kramer Novis	edad7a86-0d27-4a98-85b2-4b6725904f28	2025-11-12	Warnings	Exact identifier application number: M012
TUSSI PRES PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE	KRAMER NOVIS	b01a45df-3cea-4729-80c1-7f35b7f707f0	2025-11-12	Warnings	Exact identifier application number: M012
TUSICOF	DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE	Kramer Novis	e966b75c-4bb4-4216-8247-baada8f5d759	2025-11-12	Warnings	Exact identifier application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	52327ed0-ea49-4d1c-b928-20ab381be9f2	2025-11-11	Warnings	Exact identifier application number: M012
TOPCO Childrens Cough Relief	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Topco Associates, LLC	ee0f5627-5104-4990-88ee-2fb46965bc1e	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Childrens Cold and Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates, LLC	8931d4ca-c599-49be-87e1-8c0598f38b77	2025-11-11	Warnings	Exact identifier application number: M012
TOPCARE Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	01c517e5-d693-4926-9eb5-4b894a2f6917	2025-11-11	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435b4a2a-d6bf-ec25-e063-6294a90a3f06	2025-11-11	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435e6387-1ee0-c20f-e063-6294a90adac5	2025-11-11	Warnings	Exact identifier application number: M012
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b	2025-11-10	Warnings	Exact identifier application number: M012
TOPCARE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	Topco Associates, LLC	b5e15dd1-6e99-411c-9183-8a4265eae404	2025-11-08	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	103de130-ef12-4c58-bbcf-234b3f3b2cbf	2025-11-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	2b3fbab9-92b5-42a7-b27b-ff46350ce055	2025-11-07	Warnings	Exact identifier application number: M012
Robitussin Day and Night Maximum Strength Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b43d8fbd-1977-4465-aa64-79e7b7f54e09	2025-11-07	Warnings	Exact identifier application number: M012
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	093649a4-f968-49bd-83af-bb7e0f448ecf	2025-11-07	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	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