FDA.reportPublic FDA data

TopCare Cold Sore Treatment

Product NDC
36800-407
Requested package NDC
36800-407-01
11-digit product format
368000407
Labeler code
36800
Product ID
36800-407_5bc0faa6-bf49-4eaf-b00d-2da6df220eff
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-10
Marketing end
2021-10-05
Substance
BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC)
Active strength
1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-40736800-407-01DDiscontinued by firm2026-10-16

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-407-012021-03-03C16284748780-1ba0f9c33-34a4-a910-e053-dadaa90a0b85BPC 407 - Topco
36800-407-012021-01-29C16284748780-1ba0f9c33-34a4-a910-e053-dadaa90a0b85BPC 407 - Topco

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7TOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
BenzalkoniumACTIVE MOIETY7N6JUD5X6YTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
AlcoholINACTIVE INGREDIENT3K9958V90MTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
ArginineINACTIVE INGREDIENT94ZLA3W45FTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8TOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
CeresinINACTIVE INGREDIENTQ1LS2UJO3ATOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Cetearyl IsononanoateINACTIVE INGREDIENTP5O01U99NITOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Corymbia Citriodora Leaf OilINACTIVE INGREDIENTM63U6N96EBTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Dipropylene Glycol Caprate/Caprylate DiesterINACTIVE INGREDIENTR6G12EY23XTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
EthylparabenINACTIVE INGREDIENT14255EXE39TOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
HexyldecanolINACTIVE INGREDIENT151Z7P1317TOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Hexyldecyl LaurateINACTIVE INGREDIENT0V595C1P6MTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
LevomentholINACTIVE INGREDIENTBZ1R15MTK7TOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2TOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
ThymolINACTIVE INGREDIENT3J50XA376ETOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
TOCOPHERYL NICOTINATE, D-.ALPHA.INACTIVE INGREDIENTWI1J5UCY5CTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2
Zinc ChlorideINACTIVE INGREDIENT86Q357L16BTOPCARE COLD SORE TREATMENT (CAMPHOR) CREAM [TOPCO ASSOCIATES LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-407-01368000407011 TUBE in 1 PACKAGE (36800-407-01) > 2 g in 1 TUBE1 tube2013-04-102021-10-05NoNoCurrent