FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Nasal Four
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1087043

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-648-10Topcare Nasal Four1 in 1 CARTONSPRAY16
36800-648-10Topcare Nasal Four30 mL in 1 BOTTLE, SPRAYSPRAY306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-648-10ML - Milliliter36800-648733d32be-95aa-4c52-b3c8-540ce72ece7312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-648TOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 2 package rows20241022_99bc8829-167b-4cf8-8421-57da369f24cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSN99bc8829-167b-4cf8-8421-57da369f24cd6
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCD99bc8829-167b-4cf8-8421-57da369f24cd6
1087043phenylephrine hydrochloride 1 % Nasal SpraySY99bc8829-167b-4cf8-8421-57da369f24cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-648-10368000648101 BOTTLE, SPRAY in 1 CARTON (36800-648-10) / 30 mL in 1 BOTTLE, SPRAY2002-12-100000-00-00NoNoCurrent