FDA.reportPublic FDA data

Ulcerease

Product NDC
0316-0100
11-digit product format
003160100
Labeler code
0316
Product ID
0316-0100_ccfc1c97-5d26-70ac-e053-2a95a90a21c9
Type
HUMAN OTC DRUG
Nonproprietary name
phenol 0.6% anesthetic oral rinse
Dosage form
RINSE
Route
ORAL
Labeler
Crown Laboratories
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1977-03-28
Marketing end
0000-00-00
Substance
PHENOL
Active strength
6 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct0316-0100DDiscontinued by firm2026-08-17
excluded packagepackage0316-01000316-0100-06DDiscontinued by firm2026-08-17

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0316-0100DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0316-01000316-0100-06DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0100-062023-02-13C16284748780-1f386c64a-42bd-0266-e053-dadaa90a7c1aUlcerease Anesthetic Mouth Rinse
0316-0100-062023-01-30C16284748780-1f386c64a-42bd-0266-e053-dadaa90a7c1aUlcerease Anesthetic Mouth Rinse

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0100-06ML - Milliliter0316-0100c5ac1572-106c-4341-9c81-3062dd9313d612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0100ULCEREASE (PHENOL 0.6% ANESTHETIC ORAL RINSE) RINSE [CROWN LABORATORIES]4Legacy NDC20231216_89689542-1741-466c-e053-2995a90a7d2b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0100-0600316010006178 mL in 1 BOTTLE (0316-0100-06) 178 ml1977-03-280000-00-00NoNoCurrent