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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1000990

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-388-10Topcare Nasal30 mL in 1 BOTTLE, PUMPSPRAY, METERED305
36800-388-10Topcare Nasal1 in 1 CARTONSPRAY, METERED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-388-10ML - Milliliter36800-38847c0eedb-9609-4ca8-a1ed-b4a0dd825e3b12015-04-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-388TOPCARE NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 2 package rows20240906_b5434599-5485-4949-9d76-b1ef3ad17c1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNb5434599-5485-4949-9d76-b1ef3ad17c1a5
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDb5434599-5485-4949-9d76-b1ef3ad17c1a5
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYb5434599-5485-4949-9d76-b1ef3ad17c1a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-388-10368000388101 BOTTLE, PUMP in 1 CARTON (36800-388-10) / 30 mL in 1 BOTTLE, PUMP2002-11-260000-00-00NoNoCurrent