FDA.reportPublic FDA data

Abridge Cold Sore Treatment

Product NDC
66923-407
Requested package NDC
66923-407-01
11-digit product format
669230407
Labeler code
66923
Product ID
66923-407_ba4ac15b-be2d-4687-a89b-526b85608584
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor
Dosage form
CREAM
Route
TOPICAL
Labeler
Ranir LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-05
Marketing end
2021-05-12
Substance
CAMPHOR (SYNTHETIC); BENZALKONIUM CHLORIDE
Active strength
30 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 packagepackage66923-40766923-407-01DDiscontinued by firm2026-10-05

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, 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
66923-407-012021-02-02C16284748780-1ba0f9c33-3ebe-a910-e053-dadaa90a0b85BPC 407 - Abridge
66923-407-012021-01-29C16284748780-1ba0f9c33-3ebe-a910-e053-dadaa90a0b85BPC 407 - Abridge

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7ABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
BenzalkoniumACTIVE MOIETY7N6JUD5X6YABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
AlcoholINACTIVE INGREDIENT3K9958V90MABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
ArginineINACTIVE INGREDIENT94ZLA3W45FABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
ButylparabenINACTIVE INGREDIENT3QPI1U3FV8ABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
CeresinINACTIVE INGREDIENTQ1LS2UJO3AABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Cetearyl IsononanoateINACTIVE INGREDIENTP5O01U99NIABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Corymbia Citriodora Leaf OilINACTIVE INGREDIENTM63U6N96EBABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Dipropylene Glycol Caprate/Caprylate DiesterINACTIVE INGREDIENTR6G12EY23XABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
EthylparabenINACTIVE INGREDIENT14255EXE39ABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
HexyldecanolINACTIVE INGREDIENT151Z7P1317ABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Hexyldecyl LaurateINACTIVE INGREDIENT0V595C1P6MABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
LevomentholINACTIVE INGREDIENTBZ1R15MTK7ABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2ABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
ThymolINACTIVE INGREDIENT3J50XA376EABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
TOCOPHERYL NICOTINATE, D-.ALPHA.INACTIVE INGREDIENTWI1J5UCY5CABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4
Zinc ChlorideINACTIVE INGREDIENT86Q357L16BABRIDGE COLD SORE TREATMENT (CAMPHOR) CREAM [RANIR LLC]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66923-407-01669230407011 TUBE in 1 PACKAGE (66923-407-01) > 2 g in 1 TUBE1 tube2013-04-052021-05-12NoNoCurrent