Topcare Nasal Four

Product NDC: 36800-648
11-digit product format: 368000648
Labeler code: 36800
Product ID: 36800-648_7d5fce56-1a65-4e69-afda-9123589511de
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Topco Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-12-10
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1 g/100mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [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 Four
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087043	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
99bc8829-167b-4cf8-8421-57da369f24cd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-648-10	Topcare Nasal Four	1 in 1 CARTON	SPRAY	1		6
36800-648-10	Topcare Nasal Four	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-648-10	ML - Milliliter	36800-648	733d32be-95aa-4c52-b3c8-540ce72ece73	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	TOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	TOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-648	TOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241022_99bc8829-167b-4cf8-8421-57da369f24cd.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 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise Chest Rub Lavender	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	2472ce85-c701-4fcd-e063-6394a90a2765	2024-10-14	Warnings	Exact identifier application number: M012
HealthWise Chest Rub Lemon	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Veridian Healthcare	24740d5a-aba1-0bd4-e063-6394a90ab2ca	2024-10-14	Warnings	Exact identifier application number: M012
Childrens Plus Cough and Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43	2024-10-14	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN	Haleon US Holdings LLC	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	2024-10-14	Warnings	Exact identifier application number: M012
Cough Relief Adult	DEXTROMETHORPHAN HBR	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f5c57b32-69cb-469e-ad2d-64c00b5e66dc	2024-10-14	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Publix Super Markets Inc	94c21df5-c631-4748-a833-288b2298055c	2024-10-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	8eab9d79-69c1-44b8-9145-a7ebd887d54d	2024-10-11	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	e4963eec-fb4a-425c-be19-f514b4f10a7f	2024-10-11	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	1b4e87f8-3f9e-4865-9128-527d2d621593	2024-10-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	ff433512-55b7-4fc9-8a55-aff5cbb749ef	2024-10-11	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3170354a-4752-49a0-97ed-3d9db266a059	2024-10-11	Warnings	Exact identifier application number: M012
Tukol Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	235a6d2b-7302-410c-be35-4d5ff7bbdfce	2024-10-11	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS Pharmacy	6c7b0ea6-bff9-4fd2-9e00-64015c326ee8	2024-10-11	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Meijer Distribution Inc	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	2024-10-11	Warnings	Exact identifier application number: M012
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1087043	phenylephrine HCl 1 % Nasal Spray	PSN	99bc8829-167b-4cf8-8421-57da369f24cd	6
1087043	phenylephrine hydrochloride 10 MG/ML Nasal Spray	SCD	99bc8829-167b-4cf8-8421-57da369f24cd	6
1087043	phenylephrine hydrochloride 1 % Nasal Spray	SY	99bc8829-167b-4cf8-8421-57da369f24cd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-648-10	36800064810	1 BOTTLE, SPRAY in 1 CARTON (36800-648-10) / 30 mL in 1 BOTTLE, SPRAY	2002-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Nasal Four Drug Facts	Topco Associates LLC	2024-10-04	HUMAN OTC DRUG LABEL	6