TOPCARE No Drip Extra Moisturizing

Product NDC
36800-561
11-digit product format
368000561
Labeler code
36800
Product ID
36800-561_656aa667-2b3c-486c-b722-8c71441a1ae3
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCL
Dosage form
SPRAY
Route
NASAL
Labeler
Topco Associates LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-04-30
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 g/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-561IInactivated by FDA2026-10-05
excluded packagepackage36800-56136800-561-30IInactivated by FDA2026-10-05

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-561-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-561-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-561-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage36800-561-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage36800-561-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage36800-561-301332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-561-302024-11-21C16284748780-11030e365-4344-111a-e063-dadaa90a10e27a7fdaac-fafd-4cc1-8e6a-e843735ca6e7
36800-561-302024-01-30C16284748780-11030e365-4344-111a-e063-dadaa90a10e27a7fdaac-fafd-4cc1-8e6a-e843735ca6e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-561-30TOPCARE No Drip Extra Moisturizing30 mL in 1 BOTTLE, PUMPSPRAY303
36800-561-30TOPCARE No Drip Extra Moisturizing1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-561TOPCARE NO DRIP EXTRA MOISTURIZING (OXYMETAZOLINE HCL) SPRAY [TOPCO ASSOCIATES LLC]3Legacy NDC, 2 package rows20241122_7a7fdaac-fafd-4cc1-8e6a-e843735ca6e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN7a7fdaac-fafd-4cc1-8e6a-e843735ca6e73
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD7a7fdaac-fafd-4cc1-8e6a-e843735ca6e73
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY7a7fdaac-fafd-4cc1-8e6a-e843735ca6e73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-561-30368000561301 BOTTLE, PUMP in 1 CARTON (36800-561-30) > 30 mL in 1 BOTTLE, PUMP2022-04-300000-00-00NoNoCurrent