Antiseptic Mouth Rinse

Product NDC
55316-072
Requested package NDC
55316-072-86
11-digit product format
553160072
Labeler code
55316
Product ID
55316-072_d11a870d-7a8f-4646-9522-75c745741845
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
DZA Brands, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2001-06-29
Marketing end
0000-00-00
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
0 kg/100L; kg/100L; kg/100L; kg/100L
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55316-07255316-072-86DDiscontinued by firm2026-11-06

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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [DZA BRANDS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55316-072-86553160072861 L in 1 BOTTLE, PLASTIC (55316-072-86) 1 l2001-06-290000-00-00NoNoCurrent