FDA.reportPublic FDA data

Topcare Nasal

Product NDC
36800-907
11-digit product format
368000907
Labeler code
36800
Product ID
36800-907_fc76c4ee-54de-4f9a-a9a9-95563e4426fd
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-14
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

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
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1dd78e0-f700-4469-85d6-18cc299e8746Available on FDA.report

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
36800-907-10Topcare Nasal1 in 1 CARTONSPRAY, METERED15
36800-907-10Topcare Nasal30 mL in 1 BOTTLE, SPRAYSPRAY, METERED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-907TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 2 package rows20240906_f1dd78e0-f700-4469-85d6-18cc299e8746.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 146 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeterc92b508b-e5f9-4149-8c4b-d21845943b3b2024-10-22WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHarris Teeter2924a691-b352-4263-b6ba-9ab97e95e2a52024-10-22WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHARRIS TEETERb2091281-a64a-190a-e053-2995a90a890a2024-10-22WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINSafewaycf04bdf7-fed4-4f06-a193-f2e83fcc531c2024-10-22WarningsExact identifier
application number: M012
Tukol Honey Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAc9572b16-8e28-4f98-bd87-8a07721a49c62024-10-21WarningsExact identifier
application number: M012
Tukol Honey Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAbf25f38e-3549-4f78-be90-46605b5f2c112024-10-21WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEBb5a6719e-746b-58ec-e053-2a95a90af0102024-10-21WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEHEBa6cdc084-c23b-e733-e053-2995a90a35062024-10-21WarningsExact identifier
application number: M012
Cold Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBea39a67d-8a99-4f7c-9925-94b07d0b10922024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb7920a3-3c25-6aa1-e053-2995a90ac2b92024-10-21WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB9cbb3ab1-5f32-421e-9f28-d99be9447e9f2024-10-21WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBeb791902-e2c3-5662-e053-2995a90a37fd2024-10-21WarningsExact identifier
application number: M012
Cold Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBc3849b66-697f-4f6e-93ab-76de031b3c702024-10-21WarningsExact identifier
application number: M012
Cold Flu Severe Day NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBee1477ed-00c4-46ea-bc57-aef214076dc22024-10-21WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTHACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEB774e8bee-1ab5-4587-82e4-31da8ec835442024-10-21WarningsExact identifier
application number: M012
Mucus Relief Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba8ade-3441-f243-e053-2995a90a12302024-10-21WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHEBb1ba22ac-c38d-a42e-e053-2995a90a69002024-10-21WarningsExact identifier
application number: M012
Diphenhydramine HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst25034563-6422-daf6-e063-6394a90af9802024-10-21WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER198add5f-20b7-75b0-e063-6394a90a6bd42024-10-21WarningsExact identifier
application number: M012
Tukol Honey Children Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAdae33df8-2294-4242-a25b-2d89d1f63b232024-10-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNf1dd78e0-f700-4469-85d6-18cc299e87465
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDf1dd78e0-f700-4469-85d6-18cc299e87465
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYf1dd78e0-f700-4469-85d6-18cc299e87465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-907-10368000907101 BOTTLE, SPRAY in 1 CARTON (36800-907-10) / 30 mL in 1 BOTTLE, SPRAY2016-07-140000-00-00NoNoCurrent